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PAPILLON Trial

Phase 3 trial of amivantamab (Rybrevant) plus carboplatin-pemetrexed vs chemotherapy alone as first-line treatment for EGFR exon 20 insertion advanced NSCLC. Presented at ESMO 2023, published in NEJM; basis for the March 2024 FDA full approval.

FDA Approved · Mar 2024EGFR Exon20ins NSCLC1st-LinePhase 3Amivantamab + Chemo · Johnson & Johnson

KOL Leaders Discussing PAPILLON

Stephen V Liu, MD
Stephen V Liu, MD
@StephenVLiu
61,272 impressions
Rami Manochakian MD, FASCO 🇺🇸🇸🇾CancerEducation
Rami Manochakian MD, FASCO 🇺🇸🇸🇾CancerEducation
@RManochakian
20,917 impressions
Aakash Desai, MD, MPH
Aakash Desai, MD, MPH
@ADesaiMD
15,809 impressions
Eric K. Singhi, MD
Eric K. Singhi, MD
@lungoncdoc
13,812 impressions
Noemi Reguart
Noemi Reguart
@NReguart
6,499 impressions
Dr. Antonio Calles 🫁🚭
Dr. Antonio Calles 🫁🚭
@Tony_Calles
6,145 impressions
Dr Amol Akhade
Dr Amol Akhade
@SuyogCancer
5,957 impressions
Dipesh Uprety MD FACP
Dipesh Uprety MD FACP
@DipeshUpretyMD
5,366 impressions

Key Slides & Data

Stephen V Liu, MD
Stephen V Liu, MD @StephenVLiu
Conference Slides · Oct 4, 2025
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Zofia Piotrowska, MD, MHS DC Lung Cancer Conference 2025 October 4, 2025 JW Marriott Washington, D.C. --- PAPILLON: Front-line Amivantamab + Chemotherapy Key Eligibility Criteria Amivantamab-Chemotherapy Primary endpoint Progression - Treatment naive n° 153) Enconce Progression-free Survival by BICR locally advanced Secondary endpoints: metastatic NSCL Objective response - CRRY Documented Duration I (DoR) FGFR 20 Chemotherapy Overall 100 Median PFS insertion mutations after subsequent PF52) Median follow-up: 14.9 months EODG (95% CI) therapy Stratification Factors GOBD Amivantamab-Chemotherapy 11.4 mo (9.8-13.7) EOOG - - History train - Optional prossover Prior EGFR IKluse* amivantamab - Patients who are progression-free (%) 80 Chemotherapy 6.7 mo (5.6-7.3) California AUCS - HR, 0.395 (95% CI, 0.30-0.53); P<0.0001 NOTICE - - NO 60 48% 40 31% all Amivantamab-Chemotherapy 20 13% 3% Chemotherapy 0 0 3 6 9 12 15 18 21 24 No. at risk Months Amivantamab- Chemotherapy 153 135 105 74 50 33 15 3 0 Chemotherapy 155 131 74 41 14 4 2 1 0 Amivantamab-Chemo Chemo ORR 73% (95% CI, 65-80) 47% (95% CI, 39-56) mPFS 11.4 mo (9.8-13.7) 6.7 (95% CI, 5.6-7.3) HR 0.395 (95% CI, 0.30-0.53) [OS (interim*) NE 24.4 mo (95% CI, 22.1-NE) HR 0.675 (95% CI, 0.42-1.09)] Girard N, ESMO 2023 OS data are immature (~33% maturity), 66% of patients who progressed crossed over to amivantamab. 3 Zhou C, et al., NEJM 2023 --- Firmonertinib in EGFR exon 20 insertions FAVOUR: Phase 1B Trial of Firmonertinib in EGFR ins20 NSCLC Most Frequent TRAEs Treatment-Naive 240mg (N=30) All Grade Grade > 3 AE n (%) n (%) Previously- Previously- Diarrhea Treatment-Naive 22 (73) Treated Treated Efficacy by IRC 240mg Anemia 13 (43) 240mg 160mg N=28 AST increase N=26 N=26 8 (27) ALT increase 7 (23) Confirmed 78.6% 46.2% 38.5% ORR, % Creatinine increase 6 (20) (59-91.7) (26.6-66.6) (20.2-59.4) (95% CI) Mouth ulceration 9 (30) 1 (3) DoR, median 15.2 mo 13.1 mo 9.7 mo Rash 7 (23) (95% CI) (8.74-28.84) (5.62-13.80) (5.59-NA) QTc prolonged 8 (27) 1 (3) WBC decrease 6 (20) 1 (3) Decreased appetite 3 (10) Weight decreased 3 (10) Skin fissures 6 (20) Han B, et al, WCLC 2023 Paronychia 6 (20) 00 --- Zipalertinib (CLN-081): Activity after Amivantamab 120 100 80 Any-grade TRAEs reported in Best change from baseline in target lesions (%) 60 Any grade Grade 3 ≥10% of patients, No. (%) 40 20 Paronychia 94 (38.5) 0 0 Rash 74 (30.3) 6 (2.5) -20 Dermatitis acneiform 60 (24.6) 1 (0.4) -40 Dry skin 60 (24.6) 0 -60 Diarrhea 53 (21.7) 5 (2.0) -80 Stomatitis Platinum-based chemotherapy without ex20ins-targeted therapy (n=125) 49 (20.1) 4 (1.6) -100 Platinum-based chemotherapy with amivantamab * other ex20ins-target therapy (n=51) Anemia 48 (19.7) 17 (7.0) -120 Pruritus 44 (18.0) 1 (0.4) Nausea 35 (14.3) 2 (0.8) ORR Rash maculopapular 34 (13.9) 3 (1.2) Prior Chemo only (n=125) 40 (31-49) Fatigue 29 (11.9) 0 Prior Ami, without other Exon 20 TKIs, 30 (15-49) n=30 Prior Ami and prior Exon 20 TKIs, n=21) 14 (3-36) Yu HA, ASCO 2025 and Piotrowska Z, JCO 2025 7
Stephen V Liu, MD
Stephen V Liu, MD @StephenVLiu
Conference Slides · Jun 19, 2025
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Nicolas Girard 15:36 PAPILLON: Primary endpoint Progression-Free Survival according to site of EGFR ex20ins Ami-chemo prolonged PFS VS chemo across the different regions of Ex20ins Near loop region (n=197; 83%) Far loop region (n=30; 13%) Helical region (n=11; 5%) 100 Median follow-up. Median PFS6 100 Median follow-up: Median PFS° 100 Median follow-up: 14.9 mo Median PFS (95% CI) 14.9 mo (95% CI) 14.9 mo (95% CI) Ami-chemo 11.3 mo (9.7-13.0) Ami-chemo 9.4 mo (2.6-NE) Ami-chemo 11.1 mo (4 4-NE) 80 Chemo 5.8 mo (5 6-7.2) 80 Chemo 4.1 mo (1.5-5.7) 80 Chemo 9.1 mo (5.4-NE) HR, 0.40 (95% CI, 0.28-0.58); P<0 0001 HR, 0.19 (95% CI, 0.06-0.69); P=0 005c HR 0.55 (95% CI, 0.1-3.1); P=0 49c Patients who are progression-free (%) 60 60 60 46% 42% 40% 40 40 40 25% 20 12% 20 11% 20 0 0 0 3 6 9 12 15 18 21 24 0 3 6 9 12 15 18 21 24 0 3 6 9 12 15 18 21 24 0 Months Months Months No. at risk 71 49 34 20 8 1 0 11 9 9 5 4 3 2 0 0 5 5 4 4 1 1 1 1 0 Ami-chemo 100 90 Chemo 97 82 46 26 8 2 1 0 0 19 14 5 3 2 1 0 0 0 6 6 5 2 1 0 0 0 0 "Although the sample size was small, a trend towards improved PFS was also observed among those with helical sites of insertion Assessed by blinded independent central review (BICR) "Hazard ratio is calculated using a stratified proportional hazards model. P-value 5 calculated using a log rank test stratified by ECOG PS istory of brain metastases yes or no). Goldman, et al. WCLC 2024 CIOT: Tem Poc Ad 10 oT, --- Nicolas Girard 10:49 Exon20ins evolving landscape beyond Amivantamab Tuxobertinib (BDTX-189) EGFR/HER2 Exon20ins irreversible ATP-competitive inhibitor. BAY-2476568 STX-721 Selective & reversible EGFR exon20 ins inhibitor irreversible highly selective EGFR and ERBB2 ex20ins TKIS N lobe Exon 20 insertion YK-029A ORIC-114 3rd generation EGFR TKI EGFR/HER2 Exon20ins TKI Ph3 TKI VS chemo C lobe Sunvorzetinib Zipalertinib Pan-EGFR mutation TKI irreversible & selective EGFR exon20ins TKI Ph3 Sunvuzertinib VS chemo Ph3 Zipalertinib plus Chemo VS Chemo Furmonertinib 3rd gen EGFR/HER2 Exon20ins TKI Phase 3 ongoing Ph3 Furmonertinib VS chemo Passaro. ELCC 2024 --- Nicolas Girard 09:12 WU-KONG1B Sunvozertinib: Efficacy and safety profile Prior Prior amivantamab Best response, IO treatment treatment The most common TRAEs included n (%)* diarrhoea, blood creatinine phosphokinase With Without With Without increase, and rash (n=14) (n=93) (n=52) (n=55) CR 0 3 (3.2) 2 (3.8) 1 (1.8) 36.0% of patients had dose reduction PR 7 (50.0) 47 (50.5) 26 (50.0) 28 (50.9) 6.3% of patients had dose discontinuation PR, confirmed 5 (35.7) 41 (44.1) 23 (44.2) 23 (41.8) No patients had fatal TRAEs PR, pending confirmation 1 (7.1) 3 (3.2) 2 (3.8) 2 (3.6) Safety profiles were comparable across SD 4 (28.6) 35 (37.6) 21 (40.4) 18 (32.7) different demographics and baseline disease characteristics PD 3 (21.4) 5 (5.4) 1 (1.9) 7 (12.7) NE 0 3 (3.2) 2 (3.8) 1 (1.8) Sunvozertinib demonstrated promising efficacy in patients with advanced NSCLC harbouring EGFR exon20ins mutations, regardless of prior amivantamab or IO status "IRC-assessed. Doucet L, et al. Presented at CR, complete response; exon20ins, exon 20 insertion; IO, immunotherapy; IRC, 1260P. Independent Review Committee; NE, not evaluable; PD, progressive disease; PR, partial response; SD, stable disease; TRAE, treatment-related adverse event. --- Nicolas Girard 07:28 Best change from baseline in target lesions 120 100 Platinum-based chemotherapy without ex20ins-targeted therapy (n=125) 80 Platinum-based chemotherapy with amivantamab * other ex20ins-target therapy (n=51) Best change from baseline in target lesions (%) 60 40 20 0 -20 -40 -60 ORR,%(95%CI) -80 Prior platinum-based chemotherapy (n=125) 40 (31-49) Prior amivantamab without other ex20ins (n=30) 30 (15-49) -100 Prior amivantamab and other ex20ins (n=21) 14 (3-36) Primary efficacy population (N=176) 35 (28-43) -120 CI, confidence interval ex20ins, exon 20 insertions, ORR, objective response rate 2025 ASCO #ASCO25 PRE SENTED BY: Helena Alexandra Yu, MD ASCO AMERICAN SOCIETY OF CLINICAL ONCOLOGY KNOWLEDGE CONQUERS CANCER ANNUAL MEETING perty the author and ASCO Permission required for reuse, contact permissions@asco.org is presentation is the property of the author, licensed by ASCO. Permission required for reuse.
Stephen V Liu, MD
Stephen V Liu, MD @StephenVLiu
Conference Slides · Mar 20, 2024
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[Slide 1] Recap of ESMO 2023; Girard N, et al. 1,2 Primary Endpoint: Progression-free Survival by BICR PAPILLON Amivantamab-chemotherapy is now approved in the US for first-line treatment of EGFR Ex20ins advanced NSCLC³ 100 Median PFS Median follow-up: 14.9 mo (95% CI) Amivantamab-Chemotherapy 11.4 mo (9.8-13.7) 80 Chemotherapy 6.7 mo (5.6-7.3) HR, 0.395 (95% CI, 0.30-0.53); P<0.0001 60 48% ILL 40 ALL 31% Amivantamab-Chemotherapy 20 13% 3% Chemotherapy 0 0 3 6 9 12 15 18 21 24 Months No. at risk Ami-Chemo 153 135 105 74 50 33 15 3 0 Chemo 155 131 74 41 14 4 2 1 0 Consistent PFS benefit by investigator: 12.9 vs 6.9 mo (HR, 0.38; 95% CI, 0.29-0.51; P<0.0001) Ami-Chemo Amivantamab-Chemotherapy; BICR blinded independent central review; Chemo, Chemotherapy; CI, confidence interval; EGFR, epidermal growth factor receptor; Ex20ins, Exon 20 insertions; HR, hazard ratio; mo, months; NSCLC, non-small cell lung cancer; PFS, progression-free survival; US, United States. 1. Zhou C, et al. Engl J Med. 2023;389(22):2039-2051. 2. GirardN et al. Presented at: European Society for Medical Oncology (ESMO) 20-24 October 2023; Madrid, Spain 3.U.S. Food & Drug Administration FDA. Published online elcc March 1. 2024. Accessed March 7. 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-vmjw-egfr-exon-20-nsertion-mutated-non-small-cell-lung-cancer-indications. European Lung Cancer Congress 2024 The OR code
Stephen V Liu, MD
Stephen V Liu, MD @StephenVLiu
Conference Slides · Mar 20, 2024
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elcc European Lung Cares --- Exon20ins evolving landscape beyond Amivantamab Tuxobertinib (BDTX-189) EGFR/HER2 Exon20ins irreversible ATP-competitive inhibitor. BAY-2476568 STX-721 Selective & reversible EGFR exon20 ins inhibitor irreversible highly selective EGFR and ERBB2 ex20ins TKIS N lobe Exon 20 insertion YK-029A ORIC-114 3rd generation EGFR TKI EGFR/HER2 Exon20ins TKI Ph3 TKI VS chemo C lobe Sunvorzetinib Zipalertinib Pan-EGFR mutation TKI irreversible & selective EGFR exon20ins TKI Ph3 Sunvuzertinib VS chemo Ph3 Zipalertinib plus Chemo VS Chemo Furmonertinib 3rd gen EGFR/HER2 Exon20ins TKI Phase 3 ongoing Ph3 Furmonertinib VS chemo Antonio Passaro #ELCC24
Fabio Arcidiacono
Fabio Arcidiacono @FabArcidiacono8
Conference Slides · Mar 20, 2024
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[Slide 1] PAPILLON: post-progression analysis: what to expect? The primary reason for discontinuation was PD: 33% in the ami-chemo arm vs 69% in the chemo arm Amivantamab plus PBC PBC PAPILLON 21% 7% 11.4 PFS 6.7 HR, 0.395 21% 13.2 TTD 7.5 HR, 0.38 76% Other 30% EGFR TKI combination 17.7 EGFR TKIs TTST 9.9 Amivantamab HR, 0.35 Chemotherapy 21% Chemotherapy+IO/VEGFI NR 17.2 7% PFS2 HR, 0.49 Ami-Chemo Chemo (n=43) (n=94) The post-PD endpoints showed that PFS benefit observed with Ami+chemo in the PAPILLON study is preserved beyond first disease progression, providing strong confidence in the interim os data HRs for each post-progression endpoint all favoured Ami-chemo
Stephen V Liu, MD
Stephen V Liu, MD @StephenVLiu
Conference Slides · Mar 20, 2024
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Sites of First Progression PAPILLON Rates of first progression at all sites were lower with amivantamab-chemotherapy compared to chemotherapy Amivantamab-Chemotherapy (n=153) Lymph node 3.3% 5.2% Chemotherapy (n=155) Soft tissue/muscle 0.6% Bone 11.1% 12.3% Abdominal viscera 5.2% 18.7% Brain 5.2% 9.0% Lung/pleura 11.1% 22.6% 40% 30% 20% 10% 0% 10% 20% 30% 40% Patients (%) elcc Note: Each patient can have multiples sites of progression at first disease progression. European Lung Cancer Congress 2024 The OR code is intended to provide scientific information for individual reference, and the information should not be aftered or reproduced in any way. --- Time to Subsequent Therapy PAPILLON Median TTST was longer with amivantamab-chemotherapy compared to chemotherapy Median TTST Most Common First Subsequent Therapy Classes 100 Median follow-up 14.9 mo (95% CI) Amivantamab-Chemotherapy 17.7 mo (13.7-NE) In the amivantamab-chemotherapy arm, 43 Chemotherapy 9.9 mo (8.6-11.1) patients went on to receive subsequent 80 therapy during the study versus 94 patients in Patients without an event (%) 68% HR, 0.35 (95% CI, 0.25-0.49); P<0.0001 the chemotherapy arm 60 49% 21% 7% Otherb 40 EGFR TKI combination 36% EGFR TKIs Amivantamab-Chemotherapy Amivantamab 21% 20 Patients (%) Chemotherapy Chemotherapy+IO/VEGFi 14% 76% Chemotherapy 30% 0 0 3 6 9 12 15 18 21 24 27 No. at risk Months 21% 7% Ami-Chemo 153 144 127 98 69 43 25 12 5 0 Ami-Chemo Chemo Chemo 155 149 117 71 37 12 6 2 1 0 (n=43) (n=94) *TTST was defined as the time from the date of randomization to the start date of the first subsequent anticancer therapy following study treatment discontinuation or death, whichever occurred first. Other category included IO alone and investigational agents. "Six patients received amivantamab monotherapy off-protocol. dn the amivantamab-chemotherapy and chemotherapy arms, 23% and 1% of patients received single-agent chemotherapy, respectively, and 7% and 1% of patients received doublet chemotherapy, respectively. Ami-Chemo, Amivantamab-Chemotherapy; Chemo, Chemotherapy; CI, confidence interval; EGFR, epithelial growth factor receptor; HR, hazard ratio; IO, immuno-oncology; mo, months; NE, not estimable; elcc TKI, tyrosine kinase inhibitor; TTST, time to subsequent therapy; VEGFi, vascular endothelial growth factor inhibitor. European Lung Cancer Congress 2024 The OR code 5 intended to provide scientific information for individual and the be altered reproduced --- Crossover to 2L Q3W Amivantamab Monotherapya PAPILLON Q3W amivantamab monotherapy (n=65) showed a mPFS of 6.8 mo and a mOS of 17.7 mo (median follow-up: 9.8 mo) Median TTDᵇ was 9.7 mo (95% CI, 6.7-11.0) and median TTSTb was 9.7 mo (95% CI, 7.7-12.1) Safety and efficacy for Q3W amivantamab was consistent with the Q2W results from CHRYSALIS in post-platinum EGFR Ex20ins advanced NSCLC1 PFS: Progression-free Survival OS: Overall Survivald Median PFSc Median OSc 100 (95% CI) 100 Median follow-up: 9.8 mo Median follow-up: 9.8 mo (95% CI) Amivantamab monotherapy 6.8 mo (4.4-9.6) 80 80 70% Amivantamab monotherapy 17.7 mo (12.1-NE) Patients who are progression-free (%) 60 52% Patients who survived (%) 60 40 40 25% 20 20 0 0 0 3 6 9 12 15 18 0 3 6 9 12 15 18 21 24 No. at risk Months No. at risk Months Amivantamab Amivantamab monotherapy 65 43 22 13 5 2 0 monotherapy 65 52 44 26 15 8 3 1 0 *66% (71/107) of patients who progressed on first-line chemotherapy received amivantamab monotherapy, including 6 patients who received amivantamab off-protocol. TTD and TTST were defined as the time from first administration of amivantamab monotherapy until the date of treatment discontinuation or start of (second) subsequent therapy, respectively. °PFS and OS were defined as the time from first administration of amivantamab monotherapy until the date of objective disease progression or death, whichever occurred first, or death, respectively. There were 17 deaths reported in the crossover arm. 1L, first-line; 2L, second-line; CI, confidence interval; EGFR, epidermal growth factor receptor; Ex20ins, Exon 20 insertions; mo, months; mOS, median overall survival; mPFS, median progression-free survival; NE, not estimable; NSCLC, non-small cell lung cancer; OS, overall survival; PFS, progression-free survival; Q2W, every 2 weeks; Q3W, every 3 weeks; TTD, time to treatment discontinuation; TTST, time to subsequent therapy. elcc 1. Garrido P. et al. J Thorac Oncol. 2023;18(4S):S35-S88. European Lung Cancer Congress 2024 The OR code intended to provide scientific information for individual
Dr Amol Akhade
Dr Amol Akhade @SuyogCancer
Conference Slides · Mar 2, 2024
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Resources for Information | Approved Drugs FDA approves amivantamab- vmjw for EGFR exon 20 insertion-mutated non-small cell lung cancer indications f Share X Post Email On March 1, 2024, the Food and Drug Administration approved amivantamab- vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA- approved test. --- METHODS The NEW ENGLAND JOURNAL of MEDICINE RESEARCH SUMMARY Amivantamab plus Chemotherapy in NSCLC with EGFR Exon 20 Insertions Zhou C et al. DOI: 10.1056/NEJMoa2306441 CLINICAL PROBLEM In patients with non-small-cell lung cancer (NSCLC) with exon 20 insertions in the gene encoding epidermal growth factor receptor (EGFR), amivantamab — an EGFR mesenchymal-epithelial transition factor (MET) bispecific antibody with immune cell-directing activity — is ap- proved for use after progression occurs during or after Amivantamab EGFR receipt of first-line platinum-based chemotherapy. A pivotal phase 1 trial also showed safety and antitumor activity of amivantamab plus carboplatin-pemetrexed chemotherapy Chemotherapy (amivantamab-chemotherapy). More data on this combi- Exon 20 insertions c-MET nation therapy are needed. CLINICAL TRIAL Progression-free Survival Design: A phase 3, international, randomized trial 100 HR for disease progression or death, 0.40 (95% CI,0.30-0.53): P<0.001 assessed the efficacy and safety of amivantamab- 90 chemotherapy as compared with chemotherapy alone 80 as first-line therapy in patients with advanced NSCLC with EGFR exon 20 insertions. Percentage of Patients 70 60 Amivantamab + chemotherapy 50 11.4 mo (95% CI, 9.8-13.7) Intervention: 308 adults were assigned to receive intrave- 40 Chemotherapy nous amivantamab (1400 mg weekly for the first 4 weeks; 6.7 mo 30 (95% CI, 5.6-7.3) 1750 mg every 3 weeks starting at week 7 until progres- 20 sion occurred) plus carboplatin-pemetrexed chemotherapy 10 or chemotherapy alone, in 21-day cycles. Patients assigned 0 to chemotherapy alone could receive amivantamab mono- 0 3 6 9 12 15 18 21 24 Months since Randomization therapy after disease progression was documented. The primary outcome was progression-free survival. Most Common Adverse Events in Each Group 100 RESULTS Amivantamab . Chemotherapy Chemotherapy Efficacy: Progression-free survival was significantly 80 longer in the amivantamab-chemotherapy group than in the chemotherapy group. Safety: No new safety signal emerged for any agent. Percentage of Patients 59 60 56 54 55 45 42 40 Discontinuation of amivantamab because of adverse reactions was reported in 7% of patients. 20 0 LIMITATIONS AND REMAINING QUESTIONS Neutropenia Paronychia Rash Anemia Neutropenia Nausea Blinding of treatment assignments was not possible because of differences in drug administration, pre- medication requirements, and safety profiles. CONCLUSIONS The number of deaths in the trial was too few to provide In patients with previously untreated, advanced NSCLC robust conclusions regarding overall survival; an analysis with EGFR exon 20 insertions, progression-free survival is planned at approximately 4 years of follow-up. was significantly longer with combination amivantamab- chemotherapy than with chemotherapy alone. Links: Full Article NEJM Quick Take --- October 2, 2023 OSAKA, Japan and CAMBRIDGE, Massachusetts, October 2, 2023 - Takeda (TSE:4502/NYSE:TAK) today announced that, following discussions with the U.S. Food and Drug Administration (FDA), it will be working with the FDA towards a voluntary withdrawal of EXKIVITY® (mobocertinib) in the U.S. for adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum- based chemotherapy. Takeda intends to similarly initiate voluntary withdrawal globally where EXKIVITY is approved and is working with regulators in other countries where it is currently available on next steps. --- EXCLAIM-2 (NCT04129502) Phase 3 Trial Schema Mobocertinib 160 mg daily -Treatment naive -Locally advanced or metastatic -Nonsquamous NSCLC R -EGFR ex20ins 1:1 10 endpoint: PFS by IRC N=318 2° endpoints: ORR, OS, PFS by IA, DoR, TTR, DCR, PRO, safety Subgroup analysis 1. Brain mets (yes vs no) 2. Race (Asian vs non- Asian) Platinum/Pemetrexed X 4 Crossover to mobocertinib Pemetrexed maintenance allowed 168 clinical sites The EXCLAIM-2 (NCT04129502) phase 3 trial schema. Abbreviations: EGFR ex20ins, EGFR exon 20 insertion; DCR, disease control rate; DoR, duration of response; IA, investigator assessment; IRC, independent review committee; ORR; objective response rate; OS, overall survival; mets, metastases; NSCLC, non-small cell lung cancer; PFS, progression-free survival; PRO, patient- reported outcome; TTR, time to response; VS, versus.
Balazs Halmos
Balazs Halmos @DrSteveMartin
Conference Slides · Mar 2, 2024
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Table 9 summarizes the adverse reactions in PAPILLON. Table 9: Adverse Reactions (>10%) in Patients with Metastatic NSCLC with Exon 20 Insertion Mutations Who Received RYBREVANT in Combination with Carboplatin and Pemetrexed in PAPILLON RYBREVANT in Combination with Carboplatin and Pemetrexed Carboplatin and Pemetrexed (n=155) Adverse Reaction (n=151) All Grades Grade 3 or 4 All Grades Grade 3 or 4 (%) (%) (%) (%) Skin and subcutaneous tissue disorders Rash² 90 19 19 0 Nail toxicity2 62 7 3 0 Dry skin² 17 0 6 0 Gastrointestinal disorders Stomatitis2 43 4 11 0 Constipation 40 0 30 0.7 Nausea 36 0.7 42 0 Vomiting 21 3.3 19 0.7 Diarrhea 21 3 13 1.3 Hemorrhoids 12 1 1.3 0 Abdominal pain² 11 0.7 8 0 General disorders and administration site conditions Infusion related reaction 42 1.3 1.3 0 Fatigue² 42 6 45 3.9 Edema2 40 1.3 19 0 Pyrexia2 17 0 6 0 Metabolism and nutrition disorders Decreased appetite 36 2.6 28 1.3 Infections and Infestations COVID-19 24 2 14 0.6 Pneumonia² 13 5 6 1.9 Vascular Disorders Hemorrhage² 18 0.7 11 1.9 Respiratory, thoracic and mediastinal disorders 15 Reference ID: 5338834 Cough² 17 0 16 0 Dyspnea2 11 1.3 16 3.2 Investigations Weight decreased 14 0.7 8 0 Nervous System Disorders Dizziness² 11 0 12 0 Psychiatric Disorders Insomnia 11 0 13 0 1 Adverse reactions were graded using CTCAE version 5.0 2 Grouped Term Clinically relevant adverse reactions in <10% of patients who received RYBREVANT in combination with carboplatin and pemetrexed included pulmonary embolism, deep vein thrombosis, skin ulcer, conjunctivitis and interstitial lung disease (ILD)/pneumonitis.
Chul Kim
Chul Kim @chulkimMD
Conference Slides · Feb 22, 2024
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50. IASLC 2024 Targeted Therapies of Lung Cancer Meeting FEBRUARY 21-24, 2024 D SANTA MONICA, CALIFORNIA Amivantamab (PAPILLON: 1L) 40 Amivantamab-Chemotherapy 20 Best change from baseline in Am -chemo Chamo HR SoD of target lesions (%) 0 -20 Confirmed ORR 73% 47% -40 mDOR 9.7 mo 4.4 mo -60 . K PR mPFS 11.4 mo 6.7 mo 0.4 -00 so PD mPFS2 NE 17.2 mo 0.5 100 II NE/Unlinows mOS NE 24.4 mo 0.7 Median - 14.0 months Medium FFS Provents I : 8 - HR 0.395(90% CI, 3.30-0.53) P<0,0001 G of 3 0 0 12 15 2 21 24 Months - - SMI Abstract LBAS Zho #TTLC24 --- 50. 2024 Targeted Theraples IASLO of Lung Cancer Meeting FEBRUARY 21-24, 2024 SANTA MONICA, CALIFORNIA Sunvozertinib (DZD9008, WU-KONG6) Beefar BM IIII 10 111 0 N=97 so helical (PA) New loep (NATA) 300 mg 60 ORR=62 DCR-107% DCR=58 % 40 Confirmed ORR 60.8% 20 (BICR) I a I / 0 mDoT 7.0 months -20 -40 40 Loop classification -$0 Helical insertion (N=2) Near Loep (N 71) - -100 Far Loop (N 24) Maladies Characteristics ets 32% 26% Wang M et al. ASIO 23 (Abs 90527 ment 3% #TTLC24 --- 50 2024 Targeted Therapies IASIC FEBRUARY 21-24, 2024 SANTA MONICA, CALIFORNIA of Lung Cancer Meeting Zipalertinib (CLN-081) 100 80 60 Best Response and Change From Baseline, Sum of Target Lesions (%) N=73 40 (100mg bid, N=39) 20 Confirmed ORR 38.4% (BICR) (41%, 100mg bid) 0 -20 -40 -60 -80 yous EGFR TKI firmed response -100 Dose level 565 mg 100 mg 150 mg Por stics 38% Yu HA, et al., ACO 20 Abstract 07 36% Pintragska et BUC 2023 #TTLC24 --- 50. 2024 Targeted Theraples TASLC of Lung Cancer Meeting FEBRUARY 21-24, 2024 SANTA MONICA, CALIFORNIA ORIC-114 EGFR Exon 20 Insertion Mutations CNS responses N=21 seen, including CR ORR, all dose levels 25% in patient with prior ORR, 75mg dose 33% amivantamab Dose escalation ongoing Population Characteristics Baseline brain mets 86% Prior EGFR agent (any) 86% Prior EGFR e20ins treatment 81% 4 is 8 a al ESMO 2023 Time on Treatment #TTLC24
Stephen V Liu, MD
Stephen V Liu, MD @StephenVLiu
Conference Slides · Feb 3, 2024
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[Slide 1] Key developments in common EGFRmt and ex20ins mt NSCLC A tale of stark contrasts 1L EGFR-TKIs trials FDA approval 1L 1G EGFR-TKIs in for EGFRm NSCLC commence FDA approval 1l Osimertinib, trials afatinib dacomitinib FDA approval Publication of erlotinib pretreated RELAY study NSCLC Description of FDA approval 21 FDA approval Publication of EGFR T790M Publication of osimertinib EGFR adjuvant Publication of in AR IPASS study EURTAC study 1790M+ NSCLC osimertinib FLAURA2 2004 2006 2008 2010 2012 2014 2016 2018 2020 2022 2024 Discovery of EGFR Early phase trials Publication of mutations, ind of amivantamab, PAPILLON, ex20ins Characterisation of mobocertinib 1st report selected EGFR EXCLAIM-2 ins20 mt FDA approval amivantamab, mobocertinib post PBC 10
Jarushka Naidoo
Jarushka Naidoo @DrJNaidoo
Conference Slides · Feb 3, 2024
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M. Ross Soo --- [Input data classification] Other EGFR ex20ins inhibitors: activity and safety in pre-treated setting Study N Treatment ORR DOR PFS Dose reduction Discontinuation MDACC 50 Poziotinib 31% 8.6m 5.5m 72% 6% WU-KONG1, 2 56 Sunvozertinib 37.5% Not reached Not reported 16% 6% WU-KONG6 97 Sunvozertinib 60.8% Not reached Not reported Not reported Not reported CLN-081 73 Zipalertinib 38% 10.0m 10.0m 14% 8% FAVOUR 26 Furmonertinib 240mg 46.2% 13.1m Not reported 18% 4% FAVOUR 26 Furmonertinib 160mg 38.5% 9.7m Not reported 11% 4% POSITION20 25 Osimertinib 28% 5.3m 6.8m Not reported 8% CONCERTO 30 BLU-451 27% Not reported Not reported Not reported 0% ORIC-114 15 ORIC-114 20% Not reported Not reported 16% 4% Cell 2022; Yu Clin Oncol 40, 2022 (suppl 16; abstr 9007); Wang Cancer Discov 2022; Wang ASCO 2023; Piotrowska ICO 2023; Han WCLC 2023; Zwierenga Lung Cancer 2022; Nguyen ASCO 25 MO 2023 --- Ongoing phase III trials N 1st line Treatment Control PEP Clintrials number REZILIENT3 312 Zipalertinib+ platinum/pemetrexed Platinum/pemetrexed PFS NCT05973773 EXCLAIM-2 354 Mobocertinib Platinum/pemetrexed PFS NCT04129502 WU-KONG28 320 Sunvozertinib Carboplatin/pemetrexed PFS NCT05668988 Furmonertinib 240mg FURVENT 375 Platinum/pemetrexed PFS NCT05607550 Furmonertinib 160mg --- 30 Selected RCTs of EGFR TKIs +/-combination in EGFRm NSCLC 25 FLAURA2 MARIPOSA 20 NEJ009 RELAY FLAURA PFS 15 ARCHER1050 LUX LUNG3 10 PAPILLON EXCLAIM2 IPASS EURTAC 5 0 30 40 50 60 70 80 90 ORR
Eric K. Singhi, MD
Eric K. Singhi, MD @lungoncdoc
Conference Slides · Jan 29, 2024
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Table 1 Summary of Ongoing Clinical Trials for EGFR Ex20Ins Targeted Therapies Drug Name Trial Number Treatment Lines Phase Treatment Primary Outcome Recruitment Status Sunvozertinib NCT05668988 Frontline III Sunvozertinib VS. platinum-based chemotherapy PFS Recruiting Furmonertinib NCT05607550 Frontline III Furmonertinib VS. platinum-based chemotherapy PFS Recruiting Zipalertinib NCT05973773 Frontline III Zipalertinib-platinum-bad Chemotherapy VS. platinum-based chemotherapy PFS Recruiting YK-029A CTR20230490 Frontline III YK-029A VS. platinum-based chemotherapy PFS Recruiting JMT101 NCT05132777 Backline II JMT101+Osimertinib ORR Recruiting PLB1004 CTR20231534 Backline II PLB1004 ORR Recruiting BEBT-109 CTR20213409 Backline II BEBT-109 ORR Recruiting AP-1898 NCT04993391 Backline I/II AP-L1898 Safety and Tolerability ORR Recruiting BDTX-189 NCT04209465 Backline 1/11 BDTX-189 Phasel:Safety and Tolerability, PR2D;Phasell:ORR Recruiting HS-10376 NCT05435274 Backline I/II HS-10376 Phasela:MTD,PR2D;Phaselb/I1:ORR Recruiting BLU-451 NCT05241873 Backline I/II BLU-451 Phasel:MTD,PR2D;Phasell:ORR Recruiting BAY 2927088 NCT05099172 Backline I BAY 2927088 Safety and Tolerability Recruiting NIP142 CTR20220597 Backline I NIP142 Phasela:DLT and MTD,Phase IB:ORR Recruiting FWD1509 MsOH NCT05068024 Backline I FWD1509 MsOH Safety and Tolerability Recruiting Abbreviations: DLT = dose limiting toxicity; MTD = maximal tolerated dose; ORR = objective response rate; PFS = progression-free survival; PR2D = recommended phase II dose.
Stephen V Liu, MD
Stephen V Liu, MD @StephenVLiu
Conference Slides · Jan 13, 2024
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National Comprehensive NCCN Cancer Network® NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Non-Small Cell Lung Cancer Version 1.2024 - December 21, 2023 NCCN.org NCCN Guidelines for Patients® available at www.nccn.org/patients Continue
Aakash Desai, MD, MPH
Conference Slides · Nov 1, 2023
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[Slide 1] PAPILLON: Phase 3 Study Design Key Eligibility Criteria Amivantamab-Chemotherapy Primary endpoint: Progression-free survival Treatment-naîve a (n=153) (PFS) by BICR according to RECIST v1.1° locally advanced or Secondary endpoints: metastatic NSCLC Objective response rate (ORR)c Documented Duration of response (DoR) EGFR Exon 20 Chemotherapy Overall survival (OS)c insertion mutations (n=155) PFS after first subsequent therapy (PFS2) ECOG PS 0 or 1 Symptomatic PFS Time to subsequent therapyd Stratification Factors Dosing (in 21-day cycles) Safety ECOG PS Amivantamab: 1400 mg (1750 mg if >80 kg) for the first 4 weeks, then 1750 mg (2100 mg if >80 kg) every 3 weeks starting at week 7 (first day History of brain of cycle 3) metastases Chemotherapy on the first day of each cycle: Optional crossover to 2nd-line Prior EGFR TKI use Carboplatin: AUC5 for the first 4 cycles amivantamab monotherapy® Pemetrexed: 500 mg/m2 until disease progression PAPILLON (ClinicalTrials.gov Identifier: NCT04538664) enrollment period: December 2020 to November 2022; data cut-off: 3-May-2023. Removed as stratification factor since only 4 patients had prior EGFR TKI use (brief monotherapy with common EGFR TKIs was allowed if lack of response was documented). Patients with brain metastases were eligible if they received definitive treatment and were asymptomatic, clinically stable, and off corticosteroid treatment for >2 weeks prior to randomization. Key statistical assumption: 300 patients with 200 events needed for 90% power to detect an HR of 0.625 (estimated PFS of 8 vs 5 months). PFS, ORR, and then os were included in hierarchical testing. These secondary endpoints (time to subsequent therapy and symptomatic progression-free survival) will be presented at a future congress. *Crossover was only allowed after BICR confirmation of disease progression; amivantamab monotherapy on Q3W dosing per main study. MADRID congress ESMO AUC. area under the curve; BICR, blinded independent central review: ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; HR, hazard ratio; 2023 NSCLC, non-small cell lung cancer; Q3W, every 3 weeks; RECIST, Response Evaluation Criteria in Solid Tumors; TKI, tyrosine kinase inhibitor. Copies of this presentation obtained through OR --- [Slide 2] Primary Endpoint: Progression-free Survival by BICR Amivantamab-chemotherapy reduced risk of progression or death by 60% Median PFS 100 Median follow-up: 14.9 months (95% CI) Amivantamab-Chemotherapy 11.4 mo (9.8-13.7) Chemotherapy 6.7 mo (5.6-7.3) 80 HR, 0.395 (95% CI, 0.30-0.53); P<0.0001 60 48% LL ALL 40 31% LL T Amivantamab-Chemotherapy 20 13% 3% Chemotherapy 0 9 12 15 18 21 24 0 3 6 Months No. at risk Amivantamab- Chemotherapy 153 135 105 74 50 33 15 3 0 155 131 74 41 14 4 2 1 0 Chemotherapy Consistent PFS benefit by investigator: 12.9 vs 6.9 mo (HR, 0.38; 95% CI, 0.29-0.51; P<0.0001a) congress MADRID 2023 ESMO Nominal P-value: endpoint not part of hierarchical hypothesis testing. BICR. blinded independent central review; CI. confidence interval; HR, hazard ratio; mo, months: PFS, progression-free survival.
Aakash Desai, MD, MPH
Conference Slides · Nov 1, 2023
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[Slide 1] Safety Profile Amivantamab-Chemotherapy Chemotherapy Most common AEs of any cause (n=151) (n=155) EGFR- and MET-related AEs by preferred term (>20%), n (%) All grades Grade 3 All grades Grade 3 Associated with EGFR inhibition were increased with Paronychia 85 (56) 10 (7) 0 0 amivantamab-chemotherapy, Rash 81 (54) 17 (11) 12 (8) 0 primarily grade 1-2 Dermatitis acneiform 47 (31) 6 (4) 5 (3) 0 Stomatitis 38 (25) 2 (1) 9 (6) 0 Chemotherapy-associated Diarrhea 31 (21) 5 (3) 20 (13) 2 (1) hematologic and GI toxicities Associated with MET inhibition Hypoalbuminemia 62 (41) 6 (4) 15 (10) 0 were comparable except for Peripheral edema 45 (30) 2 (1) 16 (10) 0 neutropenia Other Neutropenia 89 (59) 50 (33) 70 (45) 35 (23) Neutropenia was transient; Anemia 76 (50) 16 (11) 85 (55) 19 (12) majority of events were not Infusion-related reaction 63 (42) 2 (1) 2 (1) 0 serious, with low rates of Constipation 60 (40) 0 47 (30) 1 (1) discontinuations Leukopenia 57 (38) 17 (11) 50 (32) 5 (3) Nausea 55 (36) 1 (1) 65 (42) 0 Pneumonitis was reported in Thrombocytopenia 55 (36) 15 (10) 46 (30) 16 (10) Decreased appetite 54 (36) 4 (3) 43 (28) 2 (1) 4 (3%) patients in the Alanine aminotransferase increased 50 (33) 6 (4) 56 (36) 2 (1) amivantamab-chemotherapy arm Aspartate aminotransferase increased 47 (31) 1 (1) 51 (33) 1 (1) COVID-19 36 (24) 3 (2) 21 (14) 1 (1) Hypokalemia 32 (21) 13 (9) 13 (8) 2 (1) Vomiting 32 (21) 5 (3) 29 (19) 1 (1) --- [Slide 2] Interim Overall Survival Amivantamab-chemotherapy shows trend in reducing risk of death by over 30% 100 74% 80 72% Amivantamab-Chemotherapy III 60 68% 54% 40 Median os Median follow-up: 14.9 months (95% CI) Amivantamab-Chemotherapy NE (NE-NE) 20 Chemotherapy 24.4 mo (22.1-NE) Chemotherapy HR, 0.675 (95% CI, 0.42-1.09); P=0.106 0 71 of 107 (66%) 0 3 6 9 12 15 18 21 24 27 patients whose No. at risk Months disease progressed Amivantamab- crossed over to Chemotherapy 153 144 133 115 88 60 38 15 5 0 amivantamab Chemotherapy 155 153 144 110 85 57 37 24 6 0 *There were 70 deaths in the study at the time of the prespecified interim os analysis, which represents 23% of all randomized patients and 33% of the -210 projected deaths for the final OS analysis. DA total of 71 patients (65 patients as part of the crossover arm plus an additional 6 patients off-protocol) received second-line amivantamab monotherapy out of 107 chemotherapy-randomized patients MADRID congress 2023 ESMO with disease progression CI, confidence interval: HR, hazard ratio; mo, months; NE, not estimable: OS, overall survival.
Aakash Desai, MD, MPH
Conference Slides · Nov 1, 2023
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Table 1 Skin toxicities of amivantamab according to the CTCAE 6.0 classification. Acnéiform rash Paronychia Cracks Hypertrichosis Hirsutism Hair changes Disorder characterized Disorder characterized by Disorder characterized by hair Disorder characterized by the Disorder by an eruption of an infectious process density or length beyond the presence of excess hair characterized by papules and pustules, involving the soft tissues accepted limits of normal in a growth in women in change in hair typically appearing in around the nail particular body region, for a anatomic sites where growth color or loss of Definition face, scalp, upper particular age or race is considered to be a normal chest and back secondary male pigmentation or characteristic and under a change in the androgen control (beard, way the hair moustache, chest, abdomen) feels Papules and/or Nail fold edema or Mild; asymptomatic or Increase in length, thickness or In women, increase in pustules covering erythema; disruption of mild symptoms; density of hair that the patient is length, thickness or density <10% BSA, which may the cuticle clinical or diagnostic either able to camouflage by of hair in a male distribution Grade 1 or may not be observations only; periodic shaving or removal of that the patient is able to Present associated with intervention not hairs or is not concerned enough camouflage by periodic symptoms of pruritus indicated. about the overgrowth to use any shaving, bleaching, or or tenderness form of hair removal removal of hair Papules and/or Local intervention Moderate; minimal, Increase in length, thickness or In women, increase in pustules covering 10 indicated; oral local or noninvasive density of hair at least on the usual length, thickness or density 30% BSA, which may intervention indicated intervention indicated; exposed areas of the body [face of hair in a male distribution or may not be (e.g., antibiotic, limiting age (not limited to beard/moustache that requires daily shaving or associated with antifungal, antiviral); nail appropriate area) plus/minus arms] that consistent destructive means symptoms of pruritus fold edema or erythema instrumental ADL requires frequent shaving or use of of hair removal to or tenderness; with pain; associated with destructive means of hair removal camouflage; associated with Grade 2 associated with discharge or nail plate to camouflage; associated with psychosocial impact psychosocial impact; separation; limiting psychosocial impact limiting instrumental instrumental ADL ADL; papules and/or pustules covering > 30% BSA with or without mild symptoms Papules and/or Operative intervention Severe or medically pustules covering indicated; IV antibiotics significant but not >30% BSA with indicated; limiting self. immediately life- moderate or severe care ADL threatening; Grade 3 symptoms; limiting hospitalization or self-care ADL; prolongation of associated with local hospitalization superinfection with indicated; disabling: oral antibiotics limiting self care ADL indicated Life-threatening consequences; papules and/or pustules covering any % BSA, which may or Grade 4 may not be associated with symptoms of pruritus or tenderness and are associated with extensive superinfection with IV antibiotics indicated Legend: BSA = Body Surface Area; ADL = Activity of Daily Life; IV = intravenous. --- Table 3 Guidelines for the management of acneiform rash/paronychia/skin fissures under amivantamab. Acneiform Rash Paronychia Cracks/Skin fissures Prevention Moisturizing 2*/day with adapted topics (balm) Moisturizing of hands and feet 2*/day (ointment) Moisturizing of hands and feet 2*/day Prophylactic antibiotic therapy by tetracycline 50 Moisturizing of the cuticule 2*/day (shea butter) (ointment) mg 2*/day Grade 1 Moisturizing 2*/day with adapted topics (balm) Moisturizing of hands and feet 2*/day (ointment) Moisturizing of hands and feet 2*/day Prophylactic antibiotic therapy by tetracycline 50 Moisturizing of the cuticule with shea butter 2*/day (ointment) to continue mg 2*/day (shea butter) Grade 2 Moisturizing to continue same posologyIncrease Stop moisturizing Moisturizing of hands and feet 2*/day posology of antibiotic therapy Disinfection with soap and water 2*/day (ointment), associated with water-free (tetracyclin 100 mg 2*/day)High level activity During 3 days: high level activity topic corticosteroids (with ointment application (specific stick for topic corticoids clobetasol propionate) 1*/day associated with occlusion: fissures) (with clobetasol propionate) once a day 7 days semi-permeable film (Tegaderm overnight, and dry And occlusion with: Cancer treatment suspension is an option to dressing during the dayIf improvement: stop occlusion and -for cracks on feet: moisturizing during 1 h consider if inefficient result continue high level activity topic corticosteroids (with 1*/day with cling film surrounding the clobetasol propionate) lesion(s) 1*/day for 7 days ion total; -for cracks on hands: moisturizing during 1 If no improvement: continue high level activity topic h 1*/day disposable gloves surrounding the corticosteroids (with clobetasol propionate) 1*/day lesion(s)Apply associated until resolution to grade 1 Orthopedic insoles can be consider If unefficient result: Consider cryotherapy Cancer treatment suspension is an option to consider if inefficient result Grade 3 Moisturizing to continue same posologyAntibiotic Implement guidelines described in Grade 2 therapy If inefficient result: (tetracycline 100 mg 2*/day)High level activity Cancer treatment suspension is highly recommended if topic corticosteroids inefficient result (with clobetasol propionate) once a day 7 days Surgical intervention is indicated when all previous Cancer treatment suspension is highly treatments are inefficient (phenolization) recommended if inefficient result Dose reduction to consider/Hospitalization in dermatology department for specific care Additional Non comedogene make up can be used to fade skin Prevention: Comfortable and large shoes to avoid friction If lesion of the heel(s): self-adherent soft Advises toxicityUse a degressive posology of topic Open-toes compression socks silicone multi-layer foam dressing con be corticosteroids after long-term application Water-soluble Nailpolish (Psoriatec) 1*/dayTreatment: used (>15 days) Local anesthetic (Lidocaine spray 5 %) can be used to make nurse careUse a degressive posology of topic corticosteroids after long-term application (>15 days) similar to the one described above in the prevention part. There is no Paronychia corresponds to skin budding along the nails. To prevent specific other treatment but emphasizing on moisturizing the skin and nails fragility we recommend an alimentation enriched in biotin, to the scalp with soothing shampoos. In case of grade 2 toxicity, topic administer nail polishes with filmogel, and to prefer comfortable and corticosteroids are recommended, as well as an increased dose of large shoes. The local prevention of paronychia is based on moisturizing tetracycline (100 mg twice a day), and if needed amivantamab can be of hands and feet, and especially of the cuticle around the nail. In tox- temporary suspended for one injection to give time for healing. In case of icities grade 2, we implemented local anesthesia before any care and grade 3 toxicity, we recommend to continue the measures implemented protection with bandage to avoid frictions. We also added a mechanical in grade 2, to suspend amivantamab until grade ≤ 2 and to consider a debridement, and topic corticosteroids application once a day for min- reduction dose of amivantamab. Hospitalization in dermatology can be imum 7 days. Antibiotherapy should not be systematic, and only if an option to consider in case of persistent grade 3 toxicity. medically indicated. We suggest cryotherapy if the treatments described A B C Fig. 3. Paronychia treated by cryotherapy. A. Grade 3 paronychia before the treatment. B. Application of the nitrous oxide on the lesion. C. At the end of the intervention. 120
Aakash Desai, MD, MPH
Conference Slides · Nov 1, 2023
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Trogocytosis and Antibody-dependent Cellular Cytotoxicity² Amivantamab-labeled NSCLC tumor cell Macrophage Macrophage Tumor Cell K Video available in Mol Cancer Ther 2020. Chemotherapy-mediated Cell Death5,⁶ Carboplatin Pemetrexed O CO2H O IZ H O O NH3 CO2H Pt HN NH3 H2N N O Tumor Cell Tumor Cell Death IZ
Stephen V Liu, MD
Stephen V Liu, MD @StephenVLiu
Conference Slides · Oct 28, 2023
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17th " Annual ATLANTA LUNG CANCER SYMPOSIUM™ --- Subtypes of EGFR mutations a EGFR-mutant patients b Atypical EGFR mutations Classical (67.1%) Classical + T790M Exon 19 Atypical (30.8%) + atypical (2.2%) 9.4% Complex Ex20ins atypical 9.1% 9.1% Exon 20ins 20.9% Ex19del 32.7% Exon 18 Other atypical 23.7% 12.6% Exon 20pt Classical + T790M 19.2% L858R + atypical 2.2% 23.0% Exon 21 T790M 0.3% Extracellular 18.1% 6.7% Classical + T790M Trans- Other 2.0% 11.1% membrane 0.4% Total = 11,619 Total = 7,199 17th Robichaux, J.P., Le, X., Vijayan, R.S.K. et al. Structure-based classification predicts drug response in EGFR-mutant NSCLC. Nature 597, 732- 737 (2021) PIM Postgraduate Institute for Medicine Bio Ascend ATLANTA LUNG CANCER SYMPOSIUM --- Papillon: Phase 3 Amivantamab + chemotherapy frontline C Overall Survival Median Overall Survival (95% CI) mo Amivantamab-Chemotherapy Not estimable 100 Chemotherapy 24.4 (22.1-not estimable) 90 80 Amivantamab-chemotherapy Percentage of Patients 70 60 50 40 30 20 Hazard ratio for death, 0.67 (95% CI, 0.42-1.09) Chemotherapy 10 P=0.11 0 0 3 6 9 12 15 18 21 24 27 Months since Randomization No. at Risk Amivantamab-chemotherapy 153 144 133 115 88 60 38 15 5 0 Chemotherapy 155 153 144 110 85 57 37 24 6 0 17th ATLANTA Zhou J. et al. NEJM. 2023. PIM Postgraduate Institute LUNG CANCER SYMPOSIUM for Medicine Bio Ascend --- Sunvozertinib: irreversible EGFR exon20 insertion (exon20ins) inhibitor amivantamab Baseline BM NNNN NNN NN NN NNNNN 80 60 PD 40 NENENDE 20 Best Tumor Size Change (%) 0 -20 -40 -60 -80 - Sunvozertinib 300 mg (N=97) - PEPR -100 WU-KONG6 (NCT05712902 and CTR20211009) confirmed ORR was 60.8% (59/97) phase II, EGFR exon20ins, progressed on/after platinum-based chemotherapy. Analysis of 97 patients 17th PIM Postgraduate Institute ATLANTA Wang M, et al. J Clin Oncol. 2023;41916_suppl):9002. for Medicine Bio Ascend LUNG CANCER SYMPOSIUM
Noemi Reguart
Noemi Reguart @NReguart
Conference Slides · Oct 21, 2023
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MADRID ESMO congress 2023 - Amivantamab Plus Chemotherapy vs Chemotherapy as First-line Treatment in EGFR Exon 20 Insertion-mutated Advanced Non-small Cell Lung Cancer (NSCLC) Primary Results From PAPILLON, a Randomized Phase 3 Global Study Nicolas Girard Keunchil Park,2.* Ke-Jing Tang,3 Byoung Chul Cho,* Luis Paz-Ares, Susanna Cheng, Satoru Kitazono, Muthukkumaran Thiagarajan,* Jonathan W. Goldman, Joshua K. Sabari, 10 Rachel E. Sanborn, 11 Aaron S. Mansfield,12 Jen-Yu Hung,13 Sanjay Popat, 14 Josiane Mourão, 15 Archan Bhattacharya, 16 Trishala Agrawal,1 S. Martin Shreeve, Roland E. Knoblauch, Caicun Zhou - I - - Theres Versites, France Send / First Unive Division Dolutes Medical I - New - Cellomia, OR, MN Claic, - High UK PA, USA CA School === Milation MO MADRID MADRID ESMocongress --- PAPILLON Primary Endpoint: Progression-free Survival by BICR Amivantamab-chemotherapy reduced risk of progression or death by 60% 100 Median PFS Median follow-up: 14.9 months (95% CI) Amivantamab-Chemotherapy 11.4 mo (9.8-13.7) Patients who are progression-free (%) 80 Chemotherapy 6.7 mo (5.6-7.3) HR, 0.395 (95% CI, 0.30-0.53); P<0.0001 60 48% 40 31% u Amivantamab-Chemotherapy 20 13% 3% Chemotherapy 0 0 3 6 9 12 15 18 21 24 No. at risk Months Amivantamab- Chemotherapy 153 135 105 74 50 33 15 3 0 Chemotherapy 155 131 74 41 14 4 2 1 0 MADRID congress Consistent PFS benefit by investigator: 12.9 vs 6.9 mo (HR, 0.38; 95% CI, 0.29-0.51; P<0.0001ᵃ) 2023 ESMD *Nominal P-value; endpoint not part of hierarchical hypothesis testing. BICR, blinded independent central review, CI, confidence interval; HR, hazard ratio, mo, months; PFS, progression-free survival
Dr. Antonio Calles 🫁🚭
Conference Slides · Oct 21, 2023
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PAPILLON Primary Endpoint: Progression-free Survival by BICR Amivantamab-chemotherapy reduced risk of progression or death by 60% 100 Median follow-up: 14.9 months Median PFS (95% CI) Amivantamab-Chemotherapy 11.4 mo (9.8-13.7) Patients who are progression-free (%) 80 Chemotherapy 6.7 mo (5.6-7.3) HR, 0.395 (95% CI, 0.30-0.53); P<0.0001 60 48% 40 31% Amivantamab-Chemotherapy 20 13% 3% Chemotherapy 0 0 3 6 9 12 15 18 21 24 No. at risk Months Amivantamab- Chemotherapy 153 135 105 74 50 33 15 3 0 Chemotherapy 155 131 74 41 14 4 2 1 0 congress Consistent PFS benefit by investigator: 12.9 vs 6.9 mo (HR, 0.38; 95% CI, 0.29-0.51; P<0.0001ᵃ) MADRID 2023 ESMO Nominal P-value; endpoint not part of hierarchical hypothesis testing. BICR, blinded independent central review, CI, confidence interval; HR, hazard ratio; mo, months; PFS, progression-free survival Capies of no - OR at for --- PAPILLON Best Response and ORR by BICR Amivantamab-Chemotherapy Chemotherapya 40 40 20 20 Best change from baseline in 0 SoD of target lesions (%) 0 -20 -40 CR Best change from baseline in SoD of target lesions (%) -20 -40 CR -60 -60 PR PR SD SD -80 -80 PD PD NE/Unknown NE/Unknown -100 -100 BICR-assessed responseb Amivantamab-Chemotherapy (n=153) Chemotherapy (n=155) Mean percent change of SoD -53%c -34% ORR 73% (95% CI, 65-80) 47% (95% CI, 39-56) Odds ratio 3.0 (95% CI, 1.8-4.8); P<0.0001 Best response, n (%) Complete response 6 (4) 1 (1) Partial response 105 (69) 71 (47) Stable disease 29 (19) 62 (41) Progressive disease 4 (3) 16 (11) NE/Unknown 8 (5) 2 (1) Median time to response 6.7 wk (range, 5.1-72.5) 11.4 wk (range, 5.1-60.2) Consistent results with investigator assessment: ORR of 66% vs 43% (OR, 2.6; P<0.0001) *Patients without postbaseline tumor assessment were not included in this plot. No. of patients with measurable disease at baseline by BICR was 152 in both arms; response data presented among all responders. Nominal P<0.001; endpoint not part of hierarchical testing. congress ADRID 23 ESMO BICR, blinded independent central review, CI, confidence interval; CR, complete response; mo, month; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease; SoD, sum of diameters; wk, weeks. Capies OR --- PAPILLON Interim Overall Survivala Amivantamab-chemotherapy shows trend in reducing risk of death by over 30% 100 80 74% 72% Patients who survived (%) Amivantamab-Chemotherapy 60 68% 54% 40 Median os Median follow-up: 14.9 months (95% CI) Amivantamab-Chemotherapy NE (NE-NE) 20 Chemotherapy 24.4 mo (22.1-NE) Chemotherapy HR, 0.675 (95% CI, 0.42-1.09); P=0.106 0 71 of 107 (66%) 0 3 6 9 12 15 18 21 24 27 patients whose No. at risk Months disease progressed Amivantamab- crossed over to Chemotherapy 153 144 133 115 88 60 38 15 5 0 amivantamabᵇ Chemotherapy 155 153 144 110 85 57 37 24 6 0 *There were 70 deaths in the study at the time of the prespecified interim OS analysis, which represents 23% of all randomized patients and 33% of the -210 projected deaths for the final OS analysis. A total of 71 patients (65 patients as part of the crossover arm plus an additional 6 patients off-protocol) received second-line amivantamab monotherapy out of 107 chemotherapy-randomized patients congress MADRID 2023 ESMO with disease progression. CI, confidence interval; HR, hazard ratio; mo, months; NE, not estimable; OS, overall survival Cash If 50 everys OR - are for personal --- PAPILLON Safety Profile Amivantamab-Chemotherapy Chemotherapy Most common AEs of any cause (n=151) (n=155) EGFR- and MET-related AEs by preferred term (>20%), n (%) All grades Grade ≥3 All grades Grade ≥3 Associated with EGFR inhibition were increased with Paronychia 85 (56) 10 (7) 0 0 amivantamab-chemotherapy, Rash 81 (54) 17 (11) 12 (8) 0 primarily grade 1-2 Dermatitis acneiform 47 (31) 6 (4) 5 (3) 0 Stomatitis 38 (25) 2 (1) 9 (6) 0 Chemotherapy-associated Diarrhea 31 (21) 5 (3) 20 (13) 2 (1) hematologic and GI toxicities Associated with MET inhibition Hypoalbuminemia 62 (41) 6 (4) 15 (10) 0 were comparable except for Peripheral edema 45 (30) 2 (1) 16 (10) 0 neutropenia Other Neutropenia 89 (59) 50 (33) 70 (45) 35 (23) Neutropenia was transient; Anemia 76 (50) 16 (11) 85 (55) 19 (12) majority of events were not Infusion-related reaction 63 (42) 2 (1) 2 (1) 0 serious, with low rates of Constipation 60 (40) 0 47 (30) 1 (1) discontinuations Leukopenia 57 (38) 17 (11) 50 (32) 5 (3) Nausea 55 (36) 1 (1) 65 (42) 0 Pneumonitis was reported in Thrombocytopenia 55 (36) 15 (10) 46 (30) 16 (10) Decreased appetite 54 (36) 4 (3) 43 (28) 2 (1) 4 (3%) patients in the Alanine aminotransferase increased 50 (33) 6 (4) 56 (36) 2 (1) amivantamab-chemotherapy arm Aspartate aminotransferase increased 47 (31) 1 (1) 51 (33) 1 (1) COVID-19 36 (24) 3 (2) 21 (14) 1 (1) Hypokalemia 32 (21) 13 (9) 13 (8) 2 (1) Vomiting 32 (21) 5 (3) 29 (19) 1 (1) congress MADRID 2023 ESMO AE, adverse event; EGFR, epidermal growth factor receptor, GI, gastrointestinal. OR com for

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Stephen V Liu, MD
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Many updates in the 1.2024 @NCCN NSCLC guidelines including: - amivantamab + carbo/pem preferred 1L for EGFR exon 20 (PAPILLON) - amivantamab + carbo/pem for #EGFR post osimertinib (MARIPOSA2) - repotrectinib for 1L #ROS1 (TRIDENT) - atezolizumab monotherapy for PS3 (IPSOS) https://t.co/J2XhWAQttS
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Rami Manochakian MD, FASCO 🇺🇸🇸🇾CancerEducation
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🔥🚨@OncoAlert Hot off the press. Press release by @JanssenUS Phase 3 #PAPILLON study, of #Amivantamab-vmjw in combination with chemo vs chemo in pts with advanced non-small cell #LungCancer with #EGFR #Exon20 mutations, met primary endpoint ⬆️ #PFS. 👇🏼 https://t.co/U28oQm0pVZ https://t.co/4qgx8pJhVP
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Do you agree? Amivantamab + Chemo is new 1L SOC for EGFR ex20ins adv NSCLC @nicogirardcurie et al. at #ESMO23 with PAPILLON study Amivantamab + CT: ⬆️ PFS (HR, 0.40); ⬆️ all subgroups ⬆️ ORR (73 vs 47%) ⬆️ DOR (9.7 vs 4.4 mo) #NSCLCBrief @LealTiciana https://t.co/4r7yPA6Bwe https://t.co/0TFs9CWtv2
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Eric K. Singhi, MD
Eric K. Singhi, MD @lungoncdoc
⚠️ High-yield @ClinicalLung review on evolving EGFR exon 20 insertion therapies Currently opting for the #PAPILLON (ami + chemo) regimen as my 1L SOC, however, eagerly awaiting data from emerging small molecule TKIs 💊 @Exon20Group @EGFRResisters #lcsm https://t.co/bEOnlTNiES https://t.co/r7RJCKN2Yg
9,459 views 39 likes 16 RT 2024-01-29
Noemi Reguart
Noemi Reguart @NReguart
Amivantamab and chemotherapy in PAPILLON hits, and stablish a NEW SoC in patients with EGFRm exon 20 insertions, 60% reduccion in the risk of progressio. (PFS 11.4 vs 6.7 mo, HR 0.395, p<0.0001). Interym analisis inmature but preliminary OS HR 0.675. #ESMO2023 https://t.co/XhK2YzDw59
6,499 views 90 likes 24 RT 2023-10-21
Dr. Antonio Calles 🫁🚭
Dr. Antonio Calles 🫁🚭 @Tony_Calles
PAPILLON Amivantamab plus Chemotherapy in NSCLC with EGFR Exon 20 Insertions What do you think? Better efficacy but challenging management of chronic side effects. Living longer, living better? #LCSM #ESMO23 https://t.co/cCBhU1fer7
6,145 views 67 likes 23 RT 2023-10-21
Stephen V Liu, MD
Stephen V Liu, MD @StephenVLiu
Dr. @EnriquetaFelip gives an update on phase III PAPILLON at #ELCC24: addition of amivantamab to 1L chemotherapy for #EGFR exon 20 NSCLC improves PFS (11.4m vs 6.7m, HR 0.395). Also improved time to treatment discontinuation (13.2m vs 7.5m, HR 0.38). #ESMOAmbassadors @myESMO https://t.co/DyFt2Z1ziD
5,521 views 74 likes 31 RT 2024-03-20
Stephen V Liu, MD
Stephen V Liu, MD @StephenVLiu
#ESMO23 Dr. @nicogirardcurie presents data from PAPILLON: the phase III study of chemotherapy +/- amivantamab (EGFR MET bispecific) for #EGFR exon 20 insertion NSCLC. Amivantamab approved as 2L - here, we see the impact of giving amivantamab up front. https://t.co/652CF7wUpU
5,432 views 51 likes 17 RT 2023-10-21
Stephen V Liu, MD
Stephen V Liu, MD @StephenVLiu
Discussion of #EGFR exon 20 and atypical mutations at #ALCS2023 by Dr. @JennyCarlisleMD. Highlights recent PAPILLON study where adding amivantamab to chemotherapy significantly improved PFS with favorable OS trend despite crossover. Stay tuned for new drugs too! https://t.co/3AcWdK4Tpa
4,819 views 55 likes 13 RT 2023-10-28
Eric K. Singhi, MD
Eric K. Singhi, MD @lungoncdoc
Looking forward to amivantamab updates at #ELCC24 1️⃣ Ph 3 MARIPOSA: 1L Ami + lazertinib, impact of dose interruptions (#1001) 2️⃣ Ph 1 PALOMA: Infusion-related reactions w/ subcutaneous Ami (#839) 3️⃣ Ph 3 PAPILLON: 1L Ami + chemo, post-progression analyses (#844) 4️⃣ Ph 3… https://t.co/EkvQlIsnHT https://t.co/dV83ejw7LQ
4,336 views 26 likes 9 RT 2024-03-20
Dr Amol Akhade
Dr Amol Akhade @SuyogCancer
So Amivantanab plus Chemotherapy has got final approval by @US_FDA for metastatic NSCLC With exon 20 insertion mutation today. Mobocertinib in same space got withdrawn in October 2023 due to negative study. What was the difference? Amivantanab study had ami plus chemo vs… https://t.co/IUhLFGdkpl https://t.co/ghyctdYKox https://t.co/qcGGwvfUf5
4,238 views 24 likes 6 RT 2024-03-02
Charu Aggarwal, MD, MPH, FASCO
Charu Aggarwal, MD, MPH, FASCO @CharuAggarwalMD
Targeted therapies continue to change the landscape of #NSCLC! @FDAOncology approves 1L #amivantamab plus chemotherapy for #EGFR exon 20 mutant NSCLC. This is a distinct subset of EGFR mutations and important for us to test and accurately treat. Approval based on PAPILLON… https://t.co/5kSCiQnWaY
3,932 views 39 likes 7 RT 2024-03-01
Stephen V Liu, MD
Stephen V Liu, MD @StephenVLiu
Learn more about today's FDA approval in this hot off the press episode of the @IASLC podcast, Lung Cancer Considered. Drs. @AngelQinMD and @MichaelBoyer1 discuss the PAPILLON study of 1L amivantamab plus chemotherapy for #EGFR exon 20 insertion NSCLC. https://t.co/WwCJeGtmv4
2,809 views 23 likes 10 RT 2024-03-01
Stephen V Liu, MD
Stephen V Liu, MD @StephenVLiu
Dr. @APassaroMD at #ELCC24 gives great insight into the #EGFR exon 20 NSCLC space. PAPILLON is our standard and as we develop new strategies, need to watch CNS efficacy and safety closely. Many agents in development - stay tuned! #ESMOAmbassadors @myESMO https://t.co/RQxOH5mdNY
2,661 views 28 likes 8 RT 2024-03-20
Stephen V Liu, MD
Stephen V Liu, MD @StephenVLiu
FDA approves first-line amivantamab plus chemotherapy for #EGFR exon 20 insertion NSCLC. Approval based on PAPILLON data presented at #ESMO23 showing addition of amivantamab to 1L chemo improved PFS (11.4m vs 6.7m, PFS HR 0.395) in #EGFRex20 NSCLC. https://t.co/a7W5yFPZpz
2,285 views 53 likes 20 RT 2024-03-01

PAPILLON Overview

PAPILLON (NCT04538664) is the pivotal Phase 3 global trial that established amivantamab plus carboplatin-pemetrexed as a first-line standard of care for advanced NSCLC harboring EGFR exon 20 insertion mutations. Presented at the 2023 ESMO Congress and published simultaneously in the New England Journal of Medicine, the trial met its primary endpoint of progression-free survival. On March 1, 2024, the FDA granted full approval to amivantamab (Rybrevant) with carboplatin and pemetrexed for this indication — the first FDA-approved frontline regimen for EGFR exon 20 insertion NSCLC. PAPILLON is the established comparator against which newer first-line options such as sunvozertinib (WU-KONG28) are now being benchmarked.

Population

Treatment-naïve locally advanced/metastatic NSCLC with EGFR exon 20 insertion mutations.

Intervention

IV amivantamab + carboplatin-pemetrexed vs carboplatin-pemetrexed alone.

Primary Endpoint

Progression-free survival by blinded independent central review (RECIST 1.1).

Key Secondary

Objective response rate, duration of response, and overall survival.

Reported Results

Progression-Free Survival (Primary Endpoint)

Amivantamab plus chemotherapy significantly improved median PFS to 11.4 months vs 6.7 months with chemotherapy alone (HR 0.40; 95% CI, 0.30–0.53; p<0.0001) at a median follow-up of 14.9 months.

Median PFS 11.4 vs 6.7 mo · HR 0.40Source: NEJM 2023 (NEJMoa2306441)

Response & Duration

Amivantamab plus chemotherapy improved objective response rate and duration of response versus chemotherapy alone; full response figures are reported in the NEJM primary publication.

Source: NEJM 2023 (NEJMoa2306441)

Safety & Tolerability

The amivantamab combination added class-typical EGFR/MET toxicities — infusion-related reactions, rash, and paronychia — on top of the chemotherapy backbone. Full adverse-event rates are detailed in the NEJM publication.

Source: NEJM 2023 (NEJMoa2306441)

FDA & Approval Status

STATUSFDA full approval — March 1, 2024

On March 1, 2024, the FDA approved amivantamab-vmjw (Rybrevant) with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations — the first FDA-approved frontline regimen for this population, based on the confirmatory Phase 3 PAPILLON study.

Source: FDA — amivantamab exon20ins approval

What KOLs Are Saying

KOLCommentSentiment
Stephen V Liu, MD
posted Jan 13, 2024
Many updates in the 1.2024 @NCCN NSCLC guidelines including: - amivantamab + carbo/pem preferred 1L for EGFR exon 20 (PAPILLON) - amivantamab + carbo/pem for #EGFR post osimertinib (MARIPOSA2) - repotrectinib for 1L #ROS1 (TRIDENT) - atezo Neutral
Rami Manochakian MD, FASCO 🇺🇸🇸🇾CancerEducation
posted Jul 17, 2023
🔥🚨@OncoAlert Hot off the press. Press release by @JanssenUS Phase 3 #PAPILLON study, of #Amivantamab-vmjw in combination with chemo vs chemo in pts with advanced non-small cell #LungCancer with #EGFR #Exon20 mutations, met primary endpoin Positive
Aakash Desai, MD, MPH
posted Nov 1, 2023
Do you agree? Amivantamab + Chemo is new 1L SOC for EGFR ex20ins adv NSCLC @nicogirardcurie et al. at #ESMO23 with PAPILLON study Amivantamab + CT: ⬆️ PFS (HR, 0.40); ⬆️ all subgroups ⬆️ ORR (73 vs 47%) ⬆️ DOR (9.7 vs 4.4 mo) #NSCLCBrie Neutral
Eric K. Singhi, MD
posted Jan 29, 2024
⚠️ High-yield @ClinicalLung review on evolving EGFR exon 20 insertion therapies Currently opting for the #PAPILLON (ami + chemo) regimen as my 1L SOC, however, eagerly awaiting data from emerging small molecule TKIs 💊 @Exon20Group @EGFRRe Neutral
Noemi Reguart
posted Oct 21, 2023
Amivantamab and chemotherapy in PAPILLON hits, and stablish a NEW SoC in patients with EGFRm exon 20 insertions, 60% reduccion in the risk of progressio. (PFS 11.4 vs 6.7 mo, HR 0.395, p<0.0001). Interym analisis inmature but preliminary OS Neutral
Dr. Antonio Calles 🫁🚭
posted Oct 21, 2023
PAPILLON Amivantamab plus Chemotherapy in NSCLC with EGFR Exon 20 Insertions What do you think? Better efficacy but challenging management of chronic side effects. Living longer, living better? #LCSM #ESMO23 https://t.co/cCBhU1fer7 Neutral
Stephen V Liu, MD
posted Mar 20, 2024
Dr. @EnriquetaFelip gives an update on phase III PAPILLON at #ELCC24: addition of amivantamab to 1L chemotherapy for #EGFR exon 20 NSCLC improves PFS (11.4m vs 6.7m, HR 0.395). Also improved time to treatment discontinuation (13.2m vs 7.5m, Neutral
Stephen V Liu, MD
posted Oct 21, 2023
#ESMO23 Dr. @nicogirardcurie presents data from PAPILLON: the phase III study of chemotherapy +/- amivantamab (EGFR MET bispecific) for #EGFR exon 20 insertion NSCLC. Amivantamab approved as 2L - here, we see the impact of giving amivantama Neutral
Stephen V Liu, MD
posted Oct 28, 2023
Discussion of #EGFR exon 20 and atypical mutations at #ALCS2023 by Dr. @JennyCarlisleMD. Highlights recent PAPILLON study where adding amivantamab to chemotherapy significantly improved PFS with favorable OS trend despite crossover. Stay tu Neutral
Eric K. Singhi, MD
posted Mar 20, 2024
Looking forward to amivantamab updates at #ELCC24 1️⃣ Ph 3 MARIPOSA: 1L Ami + lazertinib, impact of dose interruptions (#1001) 2️⃣ Ph 1 PALOMA: Infusion-related reactions w/ subcutaneous Ami (#839) 3️⃣ Ph 3 PAPILLON: 1L Ami + chemo, post-p Neutral
Dr Amol Akhade
posted Mar 2, 2024
So Amivantanab plus Chemotherapy has got final approval by @US_FDA for metastatic NSCLC With exon 20 insertion mutation today. Mobocertinib in same space got withdrawn in October 2023 due to negative study. What was the difference? Am Negative
Charu Aggarwal, MD, MPH, FASCO
posted Mar 1, 2024
Targeted therapies continue to change the landscape of #NSCLC! @FDAOncology approves 1L #amivantamab plus chemotherapy for #EGFR exon 20 mutant NSCLC. This is a distinct subset of EGFR mutations and important for us to test and accurately Neutral
Stephen V Liu, MD
posted Mar 1, 2024
Learn more about today's FDA approval in this hot off the press episode of the @IASLC podcast, Lung Cancer Considered. Drs. @AngelQinMD and @MichaelBoyer1 discuss the PAPILLON study of 1L amivantamab plus chemotherapy for #EGFR exon 20 inse Neutral
Stephen V Liu, MD
posted Mar 20, 2024
Dr. @APassaroMD at #ELCC24 gives great insight into the #EGFR exon 20 NSCLC space. PAPILLON is our standard and as we develop new strategies, need to watch CNS efficacy and safety closely. Many agents in development - stay tuned! #ESMOAmbas Positive
Stephen V Liu, MD
posted Mar 1, 2024
FDA approves first-line amivantamab plus chemotherapy for #EGFR exon 20 insertion NSCLC. Approval based on PAPILLON data presented at #ESMO23 showing addition of amivantamab to 1L chemo improved PFS (11.4m vs 6.7m, PFS HR 0.395) in #EGFRex2 Positive
Stephen V Liu, MD
posted Feb 3, 2024
Dr. Ross Soo at #ITCD2024 discusses #EGFR exon 20 insertions and notes the stark differences in progress for del19/L858R vs #EGFRex20. New 1L standard should be PAPILLON (amivantamab + chemo). Novel inhibitors in development hold promise. S Positive
Dipesh Uprety MD FACP
posted Nov 30, 2023
PAPILLON, a phase III study @NEJM ➡️Pts w/ EGFR exon 20 inser advanced NSCLC randomized to Chemo±Amivantamab ➡️↑ PFS in Amivantamab arm #LCSM @OncoAlert @BTFCancerNews https://t.co/hmjDwopVJX Positive
Rɪᴏʏᴇ Aᴜꜱᴋ
posted Feb 7, 2025
The User’s Guide to Amivantamab | Targeted Oncology https://t.co/0GQSguhE0x Neutral
Dipesh Uprety MD FACP
posted Jul 18, 2023
PRESS RELEASE: PAPILLON trial ➡️ phase-3 study of pts with advanced/metastatic NSCLC with exon 20 insertion ➡️ Randomized to carboplatin-pemetrexed vs carboplatin-pemetrexed+amivantamab ➡️↑ PFS in the amivantamab arm #LCSM @OncoAlert @BTF Neutral
Fabio Arcidiacono
posted Mar 20, 2024
#EGFR exon-20 insurmountable obstacle..the past! 👉🏻Today #PAPILLON trial with impressive results has overcome this paradigm by drastically changing prognosis of exon-20!#amivantamab-CT new 1️⃣line standard of care #EGFR exon-20 advanced #NS Positive
Dr Amol Akhade
posted Oct 21, 2023
Papillon study . AMIVANTANAB Plus chemo . For exon 20 insertion. It is successful where mobocertinib failed. They did not try head to head to chemo like mobocertinib. Good option for pts with this particular mutation. @myESMO @OncoAlert Positive
Jarushka Naidoo
posted Feb 3, 2024
#ITCD2024 Day 2 Great talk on EGFR exon20+ NSCLC by Ross Soo, highlighting: - PAPILLON is the most promising 1L option - several exon20 specific TKIs in development (alone or +CT) - outcomes still less robust vs. sensitizing EGFR mtns Positive
Stephen V Liu, MD
posted Oct 4, 2025
Dr. @ZPiotrowskaMD updates EGFR exon 20 NSCLC at #DCLung25. Amivantamab + chemotherapy as 1L standard of care with sunvozertinib now approved. Looking forward to novel agents like zipalertinib and furmonertinib - will these change 1L option Neutral
Dipesh Uprety MD FACP
posted Oct 21, 2023
PAPILLON #ESMO23 @myESMO Presidential ➡️Phase III study of Amivantamab-chemo vs Chemo for Exon 20 insertion + NSCLC (1L) ➡️↑ PFS in Amivantamab arm (Md: 11.4 vs 6.7 mo; HR 0.395) #LCSM @OncoAlert @BTFCancerNews https://t.co/wuHG7I5SIQ Neutral
Aakash Desai, MD, MPH
posted Mar 21, 2024
🎉🔑 #ELCC24: 1️⃣ PAPILLON: ami + chemo extends TTD (13.2 vs 7.5 mos) & TTST (17.7 vs 9.9 mos) in EGFR ex20 #LCSM vs chemo alone 📈 2️⃣ CheckMate 77T: neoadj nivo + chemo ⬆️ pCR regardless of # cycles completed 🎯 pCR rates: 26.7% vs 18.4% (4 v Neutral