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PALOMA-3 Trial

HR+/HER2- mBC 2L - Pfizer

HR+/HER2- mBC 2L Ibrance (palbociclib) + fulvestrant ASCO 2024 FDA Approved
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Top KOLs Discussing PALOMA-3

Eric K. Singhi, MD
Eric K. Singhi, MD
@lungoncdoc
32.6K impressions
Aakash Desai, MD, MPH
Aakash Desai, MD, MPH
@ADesaiMD
16.3K impressions
Chul Kim
Chul Kim
@chulkimMD
14.3K impressions
Yakup Ergün
Yakup Ergün
@dr_yakupergun
13.1K impressions
Shankar Siva
Shankar Siva
@_ShankarSiva
10.5K impressions
Madeleine Armstrong
Madeleine Armstrong
@ByMadeleineA
9.1K impressions

PALOMA-3 Key Slides & Visuals

Official trial slides and relevant visuals shared by KOLs at ASCO 2024. Click any image to expand.

Eric K. Singhi, MD
Eric K. Singhi, MD @lungoncdoc
PALOMA-3 Data
14.3K impressions · 17 likes · May 31, 2024
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[Slide 1] PALOMA-3 PALOMA-3: Phase 3 Study Design Ami Lazin 3LEGFR+ NSCLC Key eligibility criteria SC Amivantamab + Lazertinib Co-primary endpointsᶜ: Locally advanced or metastatic NSCLC 1:1 randomization (n=206) Ctrough (noninferiority)d Disease had progressed on or after osimertinib and platinum- (N=418) C2 AUC (noninferiority) based chemotherapy, IV Amivantamab + Lazertinib irrespective of order Secondary endpoints: Documented EGFR Ex19del (n=212) ORR (noninferiority) or L858R Dosing (in 28-day cycles) PFS (superiority) ECOG PS 0-1 SC Amivantamab (co-formulated with rHuPH20 and DoR Stratification factors administered by manual injection): 1600 mg (2240 mg if Patient satisfaction Brain metastases (yes or no) >80 kg) weekly for the first 4 weeks, then every 2 weeks thereafter EGFR mutation type (Ex19del Safety vs L858R) IV Amivantamab 1050 mg weekly (1400 mg if >80 kg) for the first 4 weeks, then every 2 weeks thereafter Race (Asian vs non-Asian) Lazertinib: 240 mg PO daily Exploratory endpoints: Type of last therapy OS (osimertinib vs chemotherapy) Prophylactic anticoagulation recommended for the first 4 months of treatment PALOMA (ClinicalTrials gov identifier (105388669) enrollment period August 2022 to October 2023; data outcif Jan 2024 PSC amivantamab ass 00 formulated with #HuPH20 at concentration of 160 mg/mL C1 for IV Days 110 2 (Day applies to IV aplit dose only (350 mg on Day and the remainder on Day 20. 8, 15. and 22. C1 for sc Days 1,8, 15 and 22. after C1 for at Days 1 and 15 (28-day cycles) For calculating primary and key secondary outcomes, we estimated that sample size of 400 patients would provide +95% power for sided alpha of 0.05 allocated to each of the co-primary endpoints and 80% power with sided alpha of 0.025 allocated to ORR hierarchical testing approach at 12 sided alpha of 0.05 NOS used for the 00 primary endpoints (noninferionly). followed by ORR (nonintenonty) and PFS (superiority). with combined sided alpha of 0.05 Two definitions of the same endpoint were used as per regional health authority guidance "Measured between C2D1 and C2D15 Assessed by modified TASQ AUC area under the concentration time curve C. Cycle Changh observed serum concentration of amivantamob at steady state 0. Day. DoR, duration of response ECOG PS, Eastem Cooperative Oncology Group performance status EGFR epidemal growth factor receptor Extidet Exon 19 deletion N. intravenous NSCLC non-small cell lung cancer ORR, objective response rate OS, overall survival PFS. progression-free survival PO. orally, rHuPH20. hyaluronidase SC. subcutaneous TASQ Therapy Administration Satisfaction Questionnaire 2024 ASCO PRE SENTED BY: Natasha 8 Leighl Copies of this stide deck obtained through Quick Response (QR) ASCO AMERICAN SOCIETY #ASCO24 Code are for personal use only and may not be reproduced without CUNICAL ONCOLOGY ANNUAL MEETING Presentation property of the author and ASCO Permission required for - contact permissions@asco.org DATE permission from ASCO or the authors of these sides KNOWLEDGE CONQUERS CANCER 2024 ASCO ANNUAL MEETING
Yakup Ergün
Yakup Ergün @dr_yakupergun
PALOMA-3 Data
13.1K impressions · 89 likes · May 31, 2024
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[Slide 1] PALOMA-3 Co-primary PK Endpoints Met Noninferiority Criteria Ami Lazin 3L EGFR+ NSCLC Cₜᵣₒugh at C2D1 C2 AUCD₁-D₁₅ Geometric mean ratio=1.15 Geometric mean ratio=1.03 (90% CI, 1.04-1.26) (90% CI, 0.98-1.09) 800 350,000 700 300,000 600 250,000 Observed Cough of amivantamab (µg/mL) 500 400 300 AUCO1.015 of amivantamab (ug-h/mL) 200,000 150,000 100,000 200 100 50,000 0 0 SC Amivantamab Arm IV Amivantamab Arm SC Amivantamab Arm IV Amivantamab Arm (n=160) (n=142) (n=140) (n=132) Geometric mean ratio for Ctrough at steady state (C4D1) was 1.43 (90% CI, 1.27-1.61) Note: The pharmacokinetic analysis for primary endpoints included all patients who received all doses without dose modification and provided the required PK samples through the final required PK sample relevant to the endpoint The upper and lower ends of the boxes indicate the 25th and 75th quarties, the triangles indicate the means, the horizontal lines within the boxes indicate the medians, and the error bars indicate 95% Cls AUC, area under the concentration time curve; C. Cycle: CI, confidence interval Crass observed serum concentration of amivantamab at steady state: D. Day, IV, intravenous PK pharmacokinetic SC. subcutaneous 2024 ASCO PRESENTED BY: Natasha B Leighl Copies of this side deck obtained through Quick Response (QR) ASCO AMERICAN SOCIETY OF #ASCO24 Code are for personal use only and may not be reproduced without CLINICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO Permission required for reuse contact permissions@asco.org permission from ASCO or the authors of these stides KNOWLEDGE CONQUERS CANCER --- [Slide 2] PALOMA-3 ORR and DoR Ami Lazir 3L EGFR+ NSCLC ORR was noninferior between the SC and IV amivantamab arms DoR was 11.2 months in the SC arm VS 8.3 months in the IV arm, with twice as many patients, 29% in the SC arm VS 14% in the IV arm, having a response ≥6 months DoR SC Amivantamab IV Amivantamab 100 Arm (n=206) Arm (n=212) ORR, % (95% CI)ᵃ 80 30 (24-37) 33 (26-39) All responders Relative risk, 0.92 (95% CI, 0.70-1.23); P=0.001 Patients who are responding (%) SC Amivantamab Arm 60 Confirmed 27 (21-33) 27 (21-33) IV Amivantamab Arm responders Relative risk, 0.99 (95% CI, 0.72-1.36); P<0.001 Best response, n (%) 40 Median DoR CR 1 (0.5) 1 (0.5) Median follow-up: 7.0 mo (95% CI) PR 61 (30) 68 (32) 20 SC Amivantamab Arm 11.2 mo (6.1-NE) SD 93 (45) 81 (38) IV Amivantamab Arm 8.3 mo (5.4-NE) PD 37 (18) 42 (20) 0 0 2 4 6 8 10 12 Not evaluable 14 (7) 20 (9) DCR, % (95% CI)b 75 (69-81) 71 (64-77) Months from date of first response Median time to No at risk 1.5 (1.2-6.9) 1.5 (1.2-9.9) SC Amivantamab Arm 55 47 30 16 11 2 0 response (range), mo IV Amivantamab Arm 57 47 25 8 4 0 0 "The objective response (CR or PR) was assessed using RECIST v1.1 and analyzed using logistic regression The lower bound of the 95% CI indicated >70% retention of CRR exceeding the predefined 60% retention assumed for determining noninferionly. Not protocol specified CI, confidence interval; CR, complete response DCR disease control rate (CR+PR+SD): DoR, duration of response, IV, intravenous; mo, months; NE, not estimable; ORR, objective response rate; PR, partial response RECIST, Response Evaluation Criteria in Solid Tumors SC, subcutaneous; SD, stable disease 2024 ASCO PRESENTED BY: Natasha B Leighl Copies of this slide deck obtained through Quick Response (QR) #ASCO24 ASCO AMERICAN SOCIETY OF Code are for personal use only and may not be reproduced without CLINICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO Permission required for reuse; contact permissions@asco permission from ASCO or the authors of these sides KNOWLEDGE CONQUERS CANCER --- [Slide 3] PALOMA-3 Progression-free Survival Ami Lazin 3L EGFR+ NSCLC PFS was numerically longer with SC VS IV amivantamab, with an HR of 0.84 100 Median PFS Median follow-up: 7.0 mo (95% CI) SC Amivantamab Arm 6.1 mo (4.3-8.1) 80 IV Amivantamab Arm 4.3 mo (4.1-5.7) Patients who are progression-free (%) HR, 0.84 (95% CI, 0.64-1.10); P=0.20 60 50% 37% 40 42% SC Amivantamab Arm 20 IV Amivantamab Arm 20% 0 0 2 4 6 8 10 12 14 16 Months No. at risk SC Amivantamab Arm 206 153 116 57 37 14 3 0 0 IV Amivantamab Arm 212 154 109 43 23 7 3 0 0 Note: The efficacy population included all the patients who had undergone randomization PFS was tested for superiority as part of the hierarchical testing strategy, P value was calculated from a rank test stratified by history of train metastases Asian race, EGFR mutation type (Ex19del or L858R). and last line of therapy (osimertinib or platinum based therapy). CI, confidence interval; EGFR epidermal growth factor receptor, Ex19del Exon 19 deletion; HR, hazard ratio; IV, intravenous mo, months; PFS, progression free survival SC. subcutaneous 2024 ASCO #ASCO24 PRESENTED BY: Natasha B Leighl Copies of this slide deck obtained through Quick Response (QR) ASCO AMERICAN SOCIETY OF Code are for personal use only and may not be reproduced without CLINICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO Permission required for reuse; contact permissions@asco.co permission from ASCO or the authors of these slides KNOWLEDGE CONQUERS CANCER --- [Slide 4] PALOMA-3 Overall Survival Ami Laz in 3LEGFR+NSCLC There was an OS benefit associated with SC amivantamab, with an HR of 0.62 compared to the IV amivantamab armᵃ Median follow-up: 7.0 mo 100 HR, 0.62 (95% CI, 0.42-0.92); nominal P=0.02 85% 80 65% 75% Patients who are alive (%) SC Amivantamab Arm 60 IV Amivantamab Arm 51% 40 20 0 0 2 4 6 8 10 12 14 16 Months No. at risk SC Amivantamab Arm 206 192 163 109 71 36 10 0 0 IV Amivantamab Arm 212 191 144 92 51 24 10 1 0 Note: The efficacy population included all the patients who had undergone randomization There were 43 deaths in the SC amivantamab arm and 62 deaths in the IV amivantamab arm Nominal P value was calculated from a log rank test stratified by history of brain metastases Asian race, EGFR mutation type (Ex19del or L858R). and last line of therapy (osimertinib or platinum-based therapy). the prespecified endpoint was exploratory and not part of hierarchical hypothesis testing CI, confidence interval EGFR epidermal growth factor receptor, Ex19del Exon 19 deletion HR hazard ratio; IV, intravenous mo. months OS, overall survival SC, subcutaneous 2024 ASCO PRESENTED BY: Natasha B Leighl Copies of this slide deck obtained through Quick Response (QR) ASCO AMERICAN SOCIETY OF #ASCO24 Code are for personal use only and may not be reproduced without CLINICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO. Permission required for reuse, contact permissions@asco org permission from ASCO or the authors of these stides KNOWLEDGE CONQUERS CANCER
Aakash Desai, MD, MPH
PALOMA-3 Data
11.4K impressions · 25 likes · May 31, 2024
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[Slide 1] ASCO ® AD Subcutaneous amivantamab ... vs intravenous amivantamab, both in combination with lazertinib, in refractory EGFR-mutated, advanced non-small cell lung cancer (NSCLC): Primary results, including overall survival (OS), from the global, phase 3, randomized controlled PALOMA-3 trial. Abstract Authors Natasha B. Leighl i Princess Margaret Cancer Centre, Toronto, ON, Canada
Shankar Siva
Shankar Siva @_ShankarSiva
PALOMA-3 Data
10.5K impressions · 49 likes · May 31, 2024
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[Slide 1] PALOMA-3 2024 ASCO ANNUAL MEETING Subcutaneous amivantamab vs intravenous amivantamab, both in combination with lazertinib, in refractory EGFR-mutated, advanced non-small cell lung cancer Primary results, including overall survival, from the global, phase 3, randomized controlled PALOMA-3 trial Natasha B Leight, Hiroaki Akamatsu,2 Sun Min Lim,3 Ying Cheng.4 Anna R Minchom,5 Melina E Marmarelis, Rachel E Sanborn,7 James Chih-Hsin Yang,8 Baogang Liu,9 Thomas John,10 Bartomeu Massuti,11 Alexander I Spira,12 John Xie, 13 Debopriya Ghosh, 13 Ali Alhadab,14 Remy B Verheijen, 15 Mohamed Gamil,16 Joshua M Bauml, 16 Mahadi Baig,¹³ Antonio Passaro17 Princess Margaret Cancer Centre, Toronto, ON, Canada; internal Medicine III, Wakayama Medical University Wakayama, Japan Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea "Jilin Cancer Hospital, Changchun China Drug Development Unit The Royal Marsden Hospital and The Institute of Cancer Research, Sutton, UK; "Division of Hematology and Oncology Department of Medicine, Perelman School of Medicine, University of Pennsylvania Philadelphia, PA USA 'Earle A Chiles Research Institute, Providence Cancer Institute, Portland, OR, USA; "Department of Medical Oncology National Taiwan University Cancer Center, Taipoi, Taiwan Harbin Medical University Cancer Hospital, Harbin China Peter MacCallum Cancer Centre, The University of Melbourne, Melbourne, Australia "Alicante University Dr Balmis Hospital ISABIAL Alicante, Spain Vrgina Cancer Specialists Fairfax, VA USA "Janssen Research & Development Raritan, NJ, USA; "Janssen Research & Development San Diego, CA, USA; "Janssen Research & Development Leiden, The Netherlands, "Janssen Research & Development Spring House, PA USA; "European Institute of Oncology IRCCS, Milano, Italy. 2024 ASCO #ASCO24 PRESENTED BY BY: Natasha B Leight Copes of the - deck oblaned through Quex Response (OR) Code are for personal - any not reproduced without ASCO ANNUAL MEETING I i - - - permission ASCOR the authors here andes KNOWLEDGE CONQUERS CANCER --- [Slide 2] PALOMA-3 PALOMA-3: Phase 3 Study Design Ami Laz in 3LEGFR+NSCLC Key eligibility criteria SC Amivantamab + Lazertinib Co-primary endpointsᶜ: Locally advanced or metastatic NSCLC 1:1 randomization (n=206) Ctrough (noninferiority)d Disease had progressed on or after osimertinib and platinum- (N=418) C2 AUC (noninferiority) based chemotherapy, IV Amivantamab + Lazertinib irrespective of order Secondary endpoints: Documented EGFR Ex19del (n=212) ORR (noninferiority) or L858R Dosing (in 28-day cycles) PFS (superiority) ECOG PS 0-1 SC Amivantamab® (co-formulated with rHuPH20 and DoR Stratification factors administered by manual injection): 1600 mg (2240 mg if Patient satisfaction Brain metastases (yes or no) >80 kg) weekly for the first 4 weeks, then every 2 weeks thereafter EGFR mutation type (Ex19del Safety vs L858R) IV Amivantamabb: 1050 mg weekly (1400 mg if >80 kg) for the first 4 weeks, then every 2 weeks thereafter Race (Asian vs non-Asian) Lazertinib: 240 mg PO daily Exploratory endpoints: Type of last therapy OS (osimertinib vs chemotherapy) Prophylactic anticoagulation recommended for the first 4 months of treatment PALOMA-3 (Clinical Trials gov Identifier NCT05388669) enrollment period August 2022 to October 2023, data outoff 03-Jan-2024 *SC amivantamab was 00- formulated with fHuPH20 at a concentration of 160 mg/mL °C1 for IV Days to 2 (Day 2 applies to IV split dose only [350 mg on Day 1 and the remainder on Day 2D. 8. 15, and 22. C1 for SC: Days 1,8, 15, and 22. after C1 for all Days 1 and 15 (28-day cycles) For calculating primary and key secondary outcomes, we estimated that a sample size of 400 patients would provide >95% power for a 1-sided alpha of 0.05 allocated to each of the co-primary endpoints and 80% power with a 1-sided alpha of 0.025 allocated to ORR A hierarchical testing approach at 2. sided alpha of 0.05 was used for the co-primary endpoints (noninferiority). followed by ORR (noninferiority) and PFS (superiority). with a combined 2-sided alpha of 0.05 Two definitions of the same endpoint were used as per regional health authority guidance "Measured between C2D1 and C2D15 Assessed by modified TASQ AUC. area under the concentration-time curve, C, Cycle: Crough observed serum concentration of amivantamab at steady state: D. Day, DoR, duration of response, ECOG PS, Eastern Cooperative Oncology Group performance status: EGFR epidermal growth factor receptor, Ex19del Exon 19 deletion; IV, intravenous NSCLC, non-small cell lung cancer, ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PO, orally, rHuPH20, hyaluronidase; SC, subcutaneous; TASQ Therapy Administration Satisfaction Questionnaire 2024 ASCO #ASCO24 PRESENTED B BY: Natasha B Leight Copies of this stude deck obtained through Quick Response (QR) Code are for personal use only and may not be reproduced without ASCO AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING Presentation - property of the author and ASCO Permission required for reuse contact permissions@asco.org permission from ASCO* or the authors of these sides KNOWLEDGE CONQUERS CANCER --- [Slide 3] PALOMA-3 ORR and DoR Ami Laz in LEGFR+ NSCLC ORR was noninferior between the SC and IV amivantamab arms DoR was 11.2 months in the SC arm vs 8.3 months in the IV arm, with twice as many patients, 29% in the SC arm vs 14% in the IV arm, having a response ≥6 months DoR SC Amivantamab IV Amivantamab 100 Arm (n=206) Arm (n=212) ORR, % (95% CI)* 80 30 (24-37) All responders 33 (26-39) Relative risk, 0.92 (95% CI, 0.70-1.23); P=0.001 Patients who are responding (%) SC Amivantamab Arm 60 Confirmed 27 (21-33) 27 (21-33) IV Amivantamab Arm responders Relative risk, 0.99 (95% CI, 0.72-1.36); P<0.001 Best response, n (%) 40 Median DoR CR 1 (0.5) 1 (0.5) Median follow-up: 7.0 mo (95% CI) PR 61 (30) 68 (32) 20 SC Amivantamab Arm 11.2 mo (6.1-NE) SD 93 (45) 81 (38) IV Amivantamab Arm 8.3 mo (5.4-NE) PD 37 (18) 42 (20) 0 0 2 4 6 8 10 12 Not evaluable 14 (7) 20 (9) DCR, % (95% CI)ᵇ 75 (69-81) 71 (64-77) Months from date of first response Median time to No. at risk 1.5 (1.2-6.9) 1.5 (1.2-9.9) SC Amivantamab Arm 55 47 30 16 11 2 0 response (range), mo IV Amivantamab Arm 57 47 25 8 4 0 0 "The objective response (CR or PR) was assessed using RECIST v1 and analyzed using logistic regression The lower bound of the 95% CI indicated >70% retention of ORR exceeding the predefined 60% retention assumed for determining noninferiority Not protocol specified CI, confidence interval, CR, complete response DCR, disease control rate (CR*PR*SD) DoR, duration of response; IV, intravenous; mo, months; NE, not estimable; ORR, objective response rate; PR partial response, RECIST, Response Evaluation Criteria in Solid Tumors: SC, subcutaneous; SD, stable disease SENTED BY: Natasha B Leight Copies of this sade deck obtained through Quick Response (QR) 2024 ASCO ASCO AMERICAN SOCIETY OF #ASCO24 Code are for personal use only and may not be reproduced without CLINICAL ONCOLOGY ANNUAL MEETING Presentation . property of the author and ASCO Permission required for reuse contact permissions@asco.org permission from ASCO* or the authors of these sides KNOWLEDGE CONQUERS CANCER --- [Slide 4] PALOMA-3 Overall Survival Ami+Lazin 3LEGFR+NSCLC There was an os benefit associated with SC amivantamab, with an HR of 0.62 compared to the IV amivantamab armª 100 Median follow-up: 7.0 mo HR, 0.62 (95% CI, 0.42-0.92); nominal P=0.02 85% 80 65% Patients who are alive (%) 75% SC Amivantamab Arm 60 IV Amivantamab Arm 51% 40 20 0 0 2 4 6 8 10 12 14 16 Months No. at risk SC Amivantamab Arm 206 192 163 109 71 36 10 0 0 IV Amivantamab Arm 212 191 144 92 51 24 10 1 0 Note: The efficacy population included all the patients who had undergone randomization There were 43 deaths in the SC amivantamab arm and 62 deaths in the IV amivantamab arm Nominal P value was calculated from a log-rank test stratified by history of brain metastases Asian race, EGFR mutation type (Ex19del or LBSBR), and last line of therapy (osimertinib or platinum-based therapy). the prespecified endpoint was exploratory and not part of hierarchical hypothesis testing CL, confidence interval EGFR, epidermal growth factor receptor, Ex196l Exon 19 deletion HR, hazard ratio; IV, intravenous; mo, months; OS, overall survival; SC, subcutaneous 2024 ASCO #ASCO24 PRE SENTED BY: Natasha B Leight Copies of this slide deck obtained through Quick Response (QR) Code are for personal use only and may not be reproduced without ASCO AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO Permission required for reuse, contact permissions@asco org. permission from ASCO* or the authors of these sides KNOWLEDGE CONQUERS CANCER
Madeleine Armstrong
Madeleine Armstrong @ByMadeleineA
PALOMA-3 Data
9.1K impressions · 16 likes · May 31, 2024
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[Slide 1] Paloma-3 data Endpoint SC Rybrevant + lazertinib IV Rybrevant + lazertinib 30% 33% ORR Relative risk, 0.92; p=0.001* mDoR 11.2mo 8.3mo 6.1mo 4.3mo PFS HR: 0.84; p=0.20** OS HR: 0.62; nominal p=0.017 Infusion-related reactions 13% 66% VTE 9% 14% Notes: *met non-inferiority criteria; **trend in favour of SC. Source: ASCO 2024.
Chul Kim
Chul Kim @chulkimMD
PALOMA-3 Data
8.4K impressions · 62 likes · May 31, 2024
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[Slide 1] PALOMA-3 ORR and DoR Ami Laz in 3L EGFR+ NSCLC ORR was noninferior between the SC and IV amivantamab arms DoR was 11.2 months in the SC arm VS 8.3 months in the IV arm, with twice as many patients, 29% in the SC arm vs 14% in the IV arm, having a response 6 months DoR SC Amivantamab IV Amivantamab 100 au Arm (n=206) Arm (n=212) ORR, % (95% CI) 80 30 (24-37) 33 (26-39) All responders SC Amivantamab Arm Relative risk, 0.92 (95% CI, 0.70-1.23); P=0.001 60 Confirmed 27 (21-33) 27 (21-33) IV Amivantamab Arm responders Relative risk, 0.99 (95% CI, 0.72-1.36); P<0.001 Best response, n (%) 40 Median DoR CR 1 (0.5) 1 (0.5) Median follow-up: 7.0 mo (95% CI) PR 61 (30) 68 (32) 20 SC Amivantamab Arm 11.2 mo (6.1-NE) SD 93 (45) 81 (38) IV Amivantamab Arm 8.3 mo (5.4-NE) PD 37 (18) 42 (20) 0 0 2 4 6 8 10 12 Not evaluable 14 (7) 20 (9) DCR, % (95% CI)b 75 (69-81) 71 (64-77) Months from date of first response Median time to No at risk 1.5 (1.2-6.9) 1.5 (1.2-9.9) SC Amivantamab Arm 55 47 30 16 11 2 0 response (range), mo IV Amivantamab Arm 57 47 25 8 4 0 0 "The objective response (CR or PR) was assessed using RECIST v1.1 and analyzed using logistic regression The lower bound of the 95% CI indicated >70% retention of ORR exceeding the predefined 60% retention assumed for determining noninferiority Not protocol specified CI. confidence interval CR complete response DCR disease control rate (CR+PR+SD) DoR duration of response IV. intravenous mo. months NE not estimable ORR objective response rate: PR partial response RECIST Response Evaluation Criteria in Solid Tumors; SC. subcutaneous SD stable disease 2024 ASCO PRESENTED BY: Natasha B Leigh Copies of this slide deck obtained through Quick Response (QR) #ASCO24 ASCO AMERICAN SOCIETY OF Code are for personal use only and may not be reproduced without CLINICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO Permission required for reuse contact permissions@asco.c org permission from ASCO or the authors of these slides KNOWLEDGE CONQUERS CANCER --- [Slide 2] PALOMA-3 Adverse Event of Special Interest: VTE Ami Laz in 3L EGFR NSCLC Prophylactic anticoagulation was administered to 80% (164/206) of patients in the SC arm and 81% (171/210) for IV Among all patients in the study, VTE was reported in 10% (32/335) of those receiving prophylactic anticoagulation vs 21% (17/81) who did not Rates of grade 3 bleeding events were uncommon in the SC (2%) and IV (1%) arms for those receiving prophylactic anticoagulation Rates of VTE by Treatment Arm and Prophylaxis Status 50 SC Ami IV Ami Grade >3 40 Grade 2 Between study arms, incidence of VTE Grade 1 was less frequent in the SC amivantamab 30 26% arm compared to the IV arm, regardless of prophylactic anticoagulation status 20 17% 14% 12% 9% 10 7% 0 n=206 n=210 n=164 n=171 n=42 n=39 All patients On prophylactic No prophylactic anticoagulation anticoagulation Note: The safety population included all the patients who had undergone randomization and received at least one dose of any trial treatment Grouping includes pulmonary embolism deep vein thrombosis venous embolism venous thrombosis limb, embolism thrombosis, subclavian vein thrombosis, superficial vein thrombosis pulmonary infarction venous thrombosis VVE prophylaxis with apixaban, rivaroxaban, dalteparin, or enoxaparin was recommended by protocol (per the National Comprehensive Cancer Network guideline Cancer-Associated Venous Thromboembolic Disease v1 2022) IV. intravenous SC. subcutaneous VTE venous thromboembolism 2024 ASCO PRESENTED BY: Natasha B Leight Copies of this slide deck obtained through Quick Response (QR) #ASCO24 Code are for personal use only and may not be reproduced without ASCO AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO Permission required for reuse; contact permissions@asco.org permission from ASCO or the authors of these slides KNOWLEDGE CONQUERS CANCER --- [Slide 3] PALOMA-3 Overall Survival Ami Laz 3LEGFR+NSCLC There was an os benefit associated with SC amivantamab, with an HR of 0.62 compared to the IV amivantamab arm Median follow-up: 7.0 mo 100 HR, 0.62 (95% CI, 0.42-0.92); nominal P=0.02 85% -LL III III 80 IIII 65% 75% ILL SC Amivantamab Arm 60 111 IV Amivantamab Arm 51% 40 20 0 0 2 4 6 8 10 12 14 16 Months No. at risk SC Amivantamab Arm 206 192 163 109 71 36 10 0 0 IV Amivantamab Arm 212 191 144 92 51 24 10 1 0 Note: The efficacy population included all the patients who had undergone randomization "There were 43 deaths in the SC amivantamab arm and 62 deaths in the IV amivantamab arm Nominal P value was calculated from log-rank test stratified by history of brain metastases Asian race EGFR mutation type (Ex19del or L858R) and last line of therapy (osimertinib or platinum-based therapy) the prespecified endpoint was exploratory and not part of hierarchical hypothesis testing CI, confidence interval; EGFR, epidermal growth factor receptor, Ex19del Exon 19 deletion; HR hazard ratio; IV, intravenous mo. months OS, overall survival SC subcutaneous 2024 ASCO PRESENTED BY: Natasha B Leigh Copies of this slide deck obtained through Quick Response (QR) ASCO AMERICAN SOCIETY OF CLINICAL ONCOLOGY #ASCO24 Code are for personal use only and may not be reproduced without ANNUAL MEETING Presentation is property of the author and ASCO Permission required for reuse contact permissions@asco.org permission from ASCO or the authors of these slides KNOWLEDGE CONQUERS CANCER
Sanjay Popat
Sanjay Popat @DrSanjayPopat
PALOMA-3 Data
6.4K impressions · 35 likes · May 31, 2024
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[Slide 1] PALOMA-3 ORR and DoR Ami Lazin ORR was noninferior between the SC and IV amivantamab arms DoR was 11.2 months in the SC arm vs 8.3 months in the IV arm, with twice as many patients, 29% in the SC arm vs 14% in the IV arm, having a response >6 months DoR SC Amivantamab IV Amivantamab 100 Arm (n=206) Arm (n=212) ORR, % (95% CI)* 80 All responders 30 (24-37) 33 (26-39) Relative risk, 0.92 (95% CI, 0.70-1.23); P=0.001 Patients who are responding (%) SC Amivantamab Arm Confirmed 60 27 (21-33) 27 (21-33) IV Amivantamab Arm responders Relative risk, 0.99 (95% CI, 0.72-1.36); P<0.001 Best response, n (%) 40 CR Median DoR 1 (0.5) 1 (0.5) Median follow-up: 7.0 mo (95% CI) PR 61 (30) 68 (32) 20 SC Amivantamab Arm 11.2 mo (6.1-NE) SD 93 (45) 81 (38) IV Amivantamab Arm 8.3 mo (5.4-NE) PD 37 (18) 42 (20) 0 0 2 4 6 8 10 12 Not evaluable 14 (7) 20 (9) DCR, % (95% CI)ᵇ 75 (69-81) 71 (64-77) Months from date of first response Median time to No at risk 1.5 (1.2-6.9) 1.5 (1.2-9.9) SC Amwantamab Arm 55 47 30 16 " 2 0 response (range), mo IV Amwantamab Arm 57 47 25 8 4 0 0 The objective response (CR or PR) - assessed using RECIST v1. 1 and analyzed using logistic regression. The lower bound of the 95% CI indicated >70% retention of ORR exceeding the predetined 60% retention assumed for determining nonintenority Not protocol specified. CL confidence interval, CR, complete response, DCR, disease control rate (CR*PR*5D). DoR, duration of response, N. intravenous, mo, months NE, not estimable ORR objective response rate, PR partial response, RECIST, Response Evaluation Cetana in Sold Tumors BC, so, stable disease 2024 ASCO SENTED BY: Natasha B Leight Copies of this sale deck octained through Quick Response (QR) #ASCO24 ASCO AMERICAN SOCIETY OF Code are for personal use only and may not be reproduced without CURICAL ONCOLOGY ANNUAL MEETING Presentation . property of the author and ASCO Permission required for reuse contact permissors@asco.org permission from ASCO® or the authors of these sides. KNOWLEDGE CONQUERS CANCER --- [Slide 2] PALOMA-3 Progression-free Survival Am Lastin 3LEGFR> NSCLO PFS was numerically longer with SC VS IV amivantamab, with an HR of 0.84 100 Median PFS Median follow-up: 7.0 mo (95% CI) SC Amivantamab Arm 6.1 mo (4.3-8.1) 80 IV Amivantamab Arm 4.3 mo (4.1-5.7) Patients who are progression-free (%) HR, 0.84 (95% CI, 0.64-1.10): P=0.20 60 50% 40 BELIL 37% 42% EL 111 SC Amivantamab Arm 20 IV Amivantamab Arm 20% 0 0 2 4 6 8 10 12 14 16 Months No. at risk SC Amivantamab Arm 206 153 116 57 37 14 3 0 0 IV Amivantamab Arm 212 154 109 43 23 7 3 0 0 Note: The efficacy population included all the patients who had undergone randomization. PFS was tested for superiority as part of the hierarchical testing strategy, P value was calculated from # log-rank test stratfied by history of train metastases, Asian race, EGFR motation type (Ex19del or LASBR), and last line of therapy (osimentinib or platinum-based therapy). CL, confidence interval, EGFR epidemal growth factor receptor, Extidel Exon 19 deletion, HR hazard ratio, IV, intravenous; mo, months PFS, progression-free survival, SC, subculaneous. 2024 ASCO PRE SENTED BY: Natasha B Leight Copies of this sade deck obtained through Quick Response (OR) Code are for personal use only and may not be reproduced without ASCO AMERICAN SOCIETY or #ASCO24 CUMICAL ONCOLOGY ANNUAL MEETING Presentation . preperty of the author and ASCO Permission required for - contact permissions@asco.org permission from ASCO* or the authors of these sides KNOWLEDGE CONQUERS CANCER --- [Slide 3] PALOMA-3 Overall Survival Ani - Lazin 3. EGFR> NSCI There was an OS benefit associated with SC amivantamab, with an HR of 0.62 compared to the IV amivantamab arm" 100 Median follow-up: 7.0 mo HR, 0.62 (95% CI, 0.42-0.92); nominal P=0.02 85% 80 65% Patients who are alive (%) 75% SC Amivantamab Arm 60 IV Amivantamab Arm 51% 40 20 0 0 2 4 6 8 10 12 14 16 Months No. at risk SC Amivantamab Arm 206 192 163 109 71 36 10 0 0 IV Amivantamab Arm 212 191 144 92 51 24 10 1 0 Note: The efficacy population included all the patients who had undergone randomization "There were 43 deaths in the SC anivantamab am and 62 deaths in the IV amivantamab am Nominal P value was calculated from . log-rank test stratified by history of brain metastases, Asian nce EGFR mutation type (Ex 19del or LBSBR). and last line of therapy (osimenting or platinum-based therapy): the prespecified endpoint was exploratory and not part of herathical hypothesis testing CI, confidence interval, EGFR epidemal growth factor receptor, Ext9del Exon 19 deletion HR hazard ratio, IV, intravenous mo, months OS, overall survival SC, subcutaneous 2024 ASCO PRE SENTED BY: Natasha B Leight Copies of this sade deck ottained through Quick Response (OR) ASCO AMERICAN SOCIETY OF #ASCO24 Code are for personal use only and may not be reproduced without CURICAL ONCOLOGY ANNUAL MEETING Presentation a property of the author and ASCO Permission required for reuse, contact permissions@ass.org permission from ASCO* or the authors of these sides KNOWLEDGE CONQUERS CANCER --- [Slide 4] PALOMA-3 Incidence of IRR-related Symptoms Ami Lazin 3. EGFR> NSCLC SC Amivantamab Arm IV Amivantamab Arm (n=206) (n=210) IRRs were observed in 13% of IRRs, all grades 13% 66% IRRs, grade 3 0. 4% patients in the SC arm vs 66% in Infusion-related the IV arm, representing a 5-fold AEs (≥2%) reduction Chills 6% 14% Pyrexia 3% 3% There were no grade 4 or 5 Dyspnea 3% 20% IRRs Nausea 3% 20% Vomiting 2% 15% Most IRRs occurred during Cough 2% 8% Hypoxia Cycle 1 2% 9% Hypotension 1% 8% Sinus tachycardia 2% 5% IRRs leading to hospitalization Erythema 1% 3% Chest discomfort were not observed in the SC arm 0.5% 6% Hypertension 0.5% 6% vs 2 events in the IV arm Flushing 12% Dizziness 4% Rash 3% No IRR-related discontinuations Hyperhidrosis 2% occurred in the SC arm vs 4 Increased heart rate 2% events in the IV arm 100% 75% 50% 25% 0% 25% 50% 75% 100% Note: The safety population included all the patients who had undergone randomization and received 21 done of any trial treatment AE, adverse event, IRR, infusion-related reaction; IV, intravenous; SO, subcutaneous 2024 ASCO PRESENTED BY: Natasha B Leight Copies of this side deck obtained through Quick Response (OR) #ASCO24 ASCO AMERICAN SOCIETY OF Code are for personal use enty and may not be reproduced without CURRICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO Permission required for mm contact permissions@asco.org permission from ASCO* or the authors of these stides KNOWLEDGE CONQUERS CANCER
Stephen V Liu, MD
Stephen V Liu, MD @StephenVLiu
PALOMA-3 Data
5.6K impressions · 9 likes · May 31, 2024
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[Slide 1] Treatment Administration Time and Convenience Treatment administration time was reduced to less than 5 minutes for SC amivantamab from 5 hours for the first infusion (2 hours for subsequent infusions) for IV amivantamab More patients reported their administration method to be convenient or very convenient with SC VS IV amivantamab Frequency of Patient-reported Convenience per Modified TASQª 100 P<0.001 P<0.001 90 80 Patient-reported convenience (%)b 70 60 50 40 85% 85% 30 52% 20 35% 10 0 SC Amivantamab IV Amivantamab SC Amivantamab IV Amivantamab Arm Arm Arm Arm (n=193) (n=195) (n=61) (n=51) C1D1d EOTe Response categories on the modified TASQ convenience question included "Very convenient", "Convenient", "Neither convenient nor inconvenient", "Inconvenient", and "Very Inconvenient". *Includes patients whose answer was "Very convenient" or "Convenient." **P values were nominal and obtained by Pearson's chi-squared test. C1D2 for patients who received IV amivantamab due to split dosing. "Could have been collected after the last dose of treatment. C, Cycle; D, Day; EOT, end of treatment; IV, intravenous; SC, subcutaneous; TASQ. Treatment Administration Satisfaction Questionnaire. 14 Presented : by NB Leight at the American Society 1 of Clinical Oncology (ASCO) Annual Meeting: May 31-June 4, 2024: Chicago, IL, USA --- [Slide 2] Conclusions SC amivantamab + lazertinib demonstrated PK and ORR noninferiority to IV amivantamab + lazertinib in patients with EGFR-mutated advanced NSCLC with disease progression on or after osimertinib and chemotherapy Compared to the IV arm, SC amivantamab also showed: - Numerically longer DoR (11.2 VS 8.3 months) and PFS (6.1 VS 4.3 months) - Significant improvement in OS (HR, 0.62; nominal P=0.02) Future studies are needed to evaluate if SC absorption via the lymphatic system enhances amivantamab's immune-mediated activity The safety profile of SC amivantamab was consistent with IV, with fewer IRRs (13% VS 66%) and VTE (9% VS 14%) Administration time was substantially shorter for SC amivantamab (median <5 minutes) VS IV amivantamab (ranging from 2 to 5 hours), with significantly more patients reporting convenience (85% VS 35% at EOT) SC amivantamab + lazertinib provided noninferior efficacy, lower rates of IRRs and VTE, and is more convenient for patients and providers vs IV amivantamab + lazertinib DoR, duration of response; EGFR, epidermal growth factor receptor; EOT, end of treatment; HR, hazard ratio; IRR, infusion-related reaction; IV, intravenous; NSCLC, non-smal cell lung cancer; ORR, objective response rate; OS, overall survivat PFS, progression-free survivat PK, pharmacokinetic; SC, subcutaneous; VTE, venous thromboembolism. 15 Presented by NB Leight at the American Society of Clinical Oncology (ASCO) Annual Meeting: May 31-June 4, 2024; Chicago, IL, USA

PALOMA-3 Top Tweets

Top 10 by impressions - click to view on X

Eric K. Singhi, MD
Eric K. Singhi, MD@lungoncdoc

Dr. Natasha Leighl now reviews data from the PALOMA-3 Trial at #ASCO24 Very excited to hear about this data regarding subcutaneous amivantamab-- a real potential to transform the...

👁 14.3K ♡ 17 ↻ 10 May 31, 2024
Yakup Ergün
Yakup Ergün@dr_yakupergun

#ASCO24 PALOMA-3 trial: SC amivantamab vs IV amivantamab (both in combination with lazertinib) 💥SC ami demonstrated noninferior PK and ORR compared to IV 📌 PFS and OS➡️longer in the...

👁 13.1K ♡ 89 ↻ 33 May 31, 2024
Aakash Desai, MD, MPH
Aakash Desai, MD, MPH@ADesaiMD

Some #LBAs already out! ➡️ PALOMA-3 (NCT05388669): SC amivantamab (ami) + lazertinib (laz) vs IV ami + laz in EGFR-mutated advanced NSCLC. 📊 Results: - Noninferior PK &amp;...

👁 11.4K ♡ 25 ↻ 9 May 31, 2024
Shankar Siva
Shankar Siva@_ShankarSiva

#lungcancer RCT of Subcutaneous versus I.V. Amivantamab (EGFR bispecific) in PALOMA-3 presented by Dr Leigh’s #ASCO24. Non-inferior for safety, efficacy + intriguing...

👁 10.5K ♡ 49 ↻ 17 May 31, 2024
Eric K. Singhi, MD
Eric K. Singhi, MD@lungoncdoc

Can’t wait to hear more about PALOMA-3 TODAY at #ASCO24 Subcutaneous Amivantamab has the potential to ⬇️ infusion-related reactions &amp; clinic visits/time that patients have...

👁 9.1K ♡ 10 ↻ 7 May 31, 2024
Madeleine Armstrong
Madeleine Armstrong@ByMadeleineA

$JNJ flies towards a more convenient Rybrevant, but has a long way to go before this is a $5bn product #ASCO24 via @ApexOnco

👁 9.1K ♡ 16 ↻ 7 May 31, 2024
Eric K. Singhi, MD
Eric K. Singhi, MD@lungoncdoc

Can’t wait to hear more about PALOMA-3 TODAY at #ASCO24 Subcutaneous Amivantamab has the potential to ⬇️ infusion-related reactions &amp; clinic visits/time that patients have...

👁 8.7K ♡ 10 ↻ 7 May 31, 2024
Chul Kim
Chul Kim@chulkimMD

PALOMA-3 trial: SC vs. IV amivantamab + lazertinib in EGFR-mutant NSCLC. Similar ORRs, numerically better PFS, improved OS with SC vs. IV. Significant reduction in IRRs with SC vs. IV (shorter...

👁 8.4K ♡ 62 ↻ 30 May 31, 2024
Charu Aggarwal, MD, MPH, FASCO
Charu Aggarwal, MD, MPH, FASCO@CharuAggarwalMD

Compelling data presented today from the PALOMA-3 trial (amivantamab) in EFGR mutant NSCLC #LCSM SC administration wins over IV and reduces burden on patients by reducing adelverse...

👁 7.8K ♡ 59 ↻ 18 May 31, 2024
Sanjay Popat
Sanjay Popat@DrSanjayPopat

PALOMA-3 SubQ vs I. Ami+lazer in post osi, post chemo setting (Dr Leighl). PK non-inferiority endpoints met. ORR non inferior. DOR and PFS and OS (sign) improved for SC. TRAEs similar between arms....

👁 6.4K ♡ 35 ↻ 12 May 31, 2024

About the PALOMA-3 Trial

PALOMA-3 is the pivotal Phase III, randomized, double-blind, placebo-controlled trial that established palbociclib (Ibrance) plus fulvestrant as a standard of care for women with HR+/HER2- advanced or metastatic breast cancer whose disease progressed on prior endocrine therapy. The trial enrolled 521 women regardless of menopausal status and demonstrated a clinically meaningful and statistically significant PFS benefit that has been supported by over 6 years of follow-up data including ctDNA biomarker analyses.

FDA Approval

FDA APPROVED Ibrance (palbociclib) — In combination with fulvestrant for the treatment of women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy

On February 19, 2016, the FDA granted regular approval for palbociclib (Ibrance) in combination with fulvestrant for HR+/HER2- mBC with disease progression following endocrine therapy, based on the PALOMA-3 trial. This expanded the original accelerated approval (February 2015) for the letrozole combination. The PALOMA-3 trial demonstrated a 4.9-month improvement in median PFS (HR 0.46; p<0.000001).

Source: FDA Press Release

Trial Methodology & Results

Study Design

Phase III, international, multicenter, 2:1 randomized, double-blind, placebo-controlled trial (NCT01942135). Patients received palbociclib 125 mg daily (3 weeks on, 1 week off) plus fulvestrant 500 mg IM, or matching placebo plus fulvestrant. Pre- and perimenopausal women also received concurrent goserelin (LHRH agonist). Stratified by sensitivity to prior hormonal therapy, menopausal status, and presence of visceral metastases.

Population

Women of any menopausal status with HR+/HER2- advanced or metastatic breast cancer whose disease progressed on or after prior endocrine therapy. Patients must have had documented disease progression during or after endocrine therapy. Up to one prior line of chemotherapy for advanced disease was permitted. ER-positive and/or PR-positive (1% or greater staining), HER2-negative by IHC or ISH.

Interventions

Palbociclib 125 mg orally daily for 21 days of every 28-day cycle plus fulvestrant 500 mg IM on Days 1 and 15 of Cycle 1, then every 28 days. Versus matching placebo plus fulvestrant on the same schedule.

Primary Endpoints

Primary endpoint: investigator-assessed PFS (RECIST 1.1). Key secondary endpoints: OS, ORR, DoR, CBR (CR/PR/SD 24 weeks or more), safety, pharmacokinetics, and patient-reported outcomes including time to deterioration in pain.

Progression-Free Survival (PFS)

Palbociclib plus fulvestrant demonstrated a clinically meaningful and statistically significant PFS improvement. At the interim analysis, median PFS was 9.2 months vs. 3.8 months (HR 0.42; 95% CI: 0.32-0.56; p<0.000001). At the final PFS analysis, median PFS was 9.5 months vs. 4.6 months (HR 0.46; 95% CI: 0.36-0.59; p<0.000001). ctDNA analyses showed PFS benefit regardless of ESR1 (HR 0.25 for ESR1-mutated), PIK3CA, or TP53 mutation status.

PFS HR 0.46 — 9.5 vs. 4.6 months

Source: FDA Approval - PALOMA-3

Overall Survival (OS)

With extended follow-up of 73.3 months, palbociclib plus fulvestrant maintained a clinically meaningful OS benefit. Median OS was 34.8 months (95% CI: 28.8-39.9) vs. 28.0 months (95% CI: 23.5-33.8) (stratified HR 0.81; 95% CI: 0.65-0.99). 5-year OS rate: 23.3% vs. 16.7%. 6-year OS rate: 19.1% vs. 12.9%. In patients without prior chemotherapy for ABC, median OS was 39.3 months vs. 29.7 months (HR 0.72; 95% CI: 0.55-0.94). The earlier protocol-specified final OS analysis (median follow-up 44.8 months) showed median OS of 34.9 vs. 28.0 months (HR 0.81; 95% CI: 0.64-1.03; p=0.0429), which did not reach the prespecified significance threshold. Patients with ESR1 mutations showed OS HR 0.59 (95% CI: 0.37-0.94).


Source: Clinical Cancer Research - 73-Month OS Follow-up

Safety & Tolerability

The safety profile was generally tolerable with adverse reactions manageable through dose modifications. Neutropenia was the most common AE: 83% all-grade (Grade 3: 55%, Grade 4: 11%). Febrile neutropenia was rare (0.9-1.8%). Other common AEs: leukopenia 53%, infections 47%, fatigue 41%, nausea 34%, anemia 30%, stomatitis 28%. Permanent discontinuation due to AEs: 6% (palbociclib) vs. 3% (placebo). One death from neutropenic sepsis was recorded. QoL was maintained or improved; median time to deterioration in pain was 8.0 months vs. 2.8 months (HR 0.642; p<0.001).

Manageable neutropenia — 6% discontinuation rate

Source: Ibrance Prescribing Information

Clinical Implications

PALOMA-3 established palbociclib plus fulvestrant as a standard of care for HR+/HER2- mBC after prior endocrine therapy. The extended 6-year follow-up confirmed a clinically meaningful OS benefit, particularly in patients without prior chemotherapy and those with endocrine-sensitive disease. The ctDNA biomarker analyses revealed that ESR1-mutated patients derive the greatest benefit (PFS HR 0.25, OS HR 0.59), suggesting a potential role for liquid biopsy-guided treatment selection. Key debate: while no OS benefit was formally significant at the protocol-specified analysis, the consistent trend with extended follow-up and the OS benefit in the no-prior-chemotherapy subgroup support CDK4/6 inhibitor therapy in this setting.

PALOMA-3 in the News

Key KOL Sentiments - PALOMA-3

DoctorSentimentComment
Eric K. Singhi, MD
@lungoncdoc
● POSITIVE Dr. Natasha Leighl now reviews data from the PALOMA-3 Trial at #ASCO24 Very excited to hear about this data regarding subcutaneous amivantamab-- a real potential to transform the current patient experience with this drug @oncoalert @ASCO https://t.
Shankar Siva
@_ShankarSiva
● POSITIVE #lungcancer RCT of Subcutaneous versus I.V. Amivantamab (EGFR bispecific) in PALOMA-3 presented by Dr Leigh’s #ASCO24. Non-inferior for safety, efficacy + intriguing exploratory finding of ⬆️ OS with S/C delivery! Only 13% vs 66% infusion reaction wi
Chul Kim
@chulkimMD
● POSITIVE PALOMA-3 trial: SC vs. IV amivantamab + lazertinib in EGFR-mutant NSCLC. Similar ORRs, numerically better PFS, improved OS with SC vs. IV. Significant reduction in IRRs with SC vs. IV (shorter administration time as well)! A great option for patie
● POSITIVE Compelling data presented today from the PALOMA-3 trial (amivantamab) in EFGR mutant NSCLC #LCSM SC administration wins over IV and reduces burden on patients by reducing adelverse events (toxicity), time toxicity and financial toxicity @ASCO #ASCO
Sanjay Popat
@DrSanjayPopat
● POSITIVE PALOMA-3 SubQ vs I. Ami+lazer in post osi, post chemo setting (Dr Leighl). PK non-inferiority endpoints met. ORR non inferior. DOR and PFS and OS (sign) improved for SC. TRAEs similar between arms. Marked reduction in IRRs #ASCO24 https://t.co/KBioHt
Stephen V Liu, MD
@StephenVLiu
● POSITIVE #ASCO24 Importantly, subcutaneous amivantamab reduces administration time and improves convenience. Patient-forward approach. To me, would absolutely favor subcutaneous over intravenous delivery. #PALOMA3 https://t.co/vIT2SyvLev
Sandip Patel MD
@PatelOncology
● POSITIVE Time toxicity is an under appreciated patient challenge . Subq amivantamab vs IV compared in PALOMA3. Numerical improved survival with Subq as well. Eagerly awaited approval I would switch to Subq the day it’s approved. #ASCO2024, #MedIQASCO2024 http
● POSITIVE Great session on #targetedtherapies, w/ brilliant discussion by @JessicaJLinMD! 💠Interesting STARLET pooled RCT analysis of osi w/ or w/o SRS for🧠mets➡️no significant🧠PFS benefit with upfront SRS 💠QOL data from KRYSTAL12 &amp; PALOMA3, showing🔑role o
Jennifer A. Marks, MD
@jennifermarksmd
● POSITIVE Time toxicities for patients much improved with subq #amivantamab as per PALOMA-3: &lt;5 mins vs 5h @EGFRResisters @EGFRmNSCLC @JessicaJLinMD #ASCO24 @asco #lcsm https://t.co/8xD6HWkgco
● POSITIVE Excited to see our 4th Phase 3 PALOMA-3 🦋 study being presented here at #ASCO24 for amivantamab. #MyCompany https://t.co/fjlYNrGQKA
Dr Riyaz Shah
@DrRiyazShah
● POSITIVE Definite better tox profile and more convenient https://t.co/1i9RnvBA1z
OncoHeb
@EoHeb
● POSITIVE #ASCO24 PALOMA-3 (not to be confused with the breast cancer-related trial) proved that NSCLC EGFRmut patients (ex19del, L858R), focusing on non-inferiority, can receive SC instead of IV amivantamab, with oral lazertinib as 3rd line. Kudos on focusing
Aman Bhargava
@theamanbhargava
● POSITIVE @CharuAggarwalMD @ASCO @OncoAlert @EGFRResisters Does this reduced toxicity in Exon 19 del patients also transfer to Exon 20 ins pts on Chemo + Amivantamab? Thanks for your time Dr.!
Yves Boucher
@DigitalDrYB
● POSITIVE @chulkimMD Incredible results from PALOMA-3! SC administration truly enhances patient experience with fewer IRRs and shorter administration times. A major advancement in EGFR-mutant NSCLC. #ASCO24
Prunella Blinman
@drprunellab
● POSITIVE @DrSanjayPopat Great trial. Big win for people with lung cancer on Ami.
Ryan Gentzler, MD
@ryangentzler
● POSITIVE @PatelOncology 5 hours is just the infusion time. Skipping day 2 trip to the infusion center saves half a day or more for the patient when you include travel from home, wait time, getting IV access. OS data was an unexpected bonus. Agree FDA approv
Yakup Ergün
@dr_yakupergun
● NEUTRAL #ASCO24 PALOMA-3 trial: SC amivantamab vs IV amivantamab (both in combination with lazertinib) 💥SC ami demonstrated noninferior PK and ORR compared to IV 📌 PFS and OS➡️longer in the SC arm vs IV🤯 Presented by Dr. Natasha B. Leighl @OncoAlert https
● NEUTRAL Some #LBAs already out! ➡️ PALOMA-3 (NCT05388669): SC amivantamab (ami) + lazertinib (laz) vs IV ami + laz in EGFR-mutated advanced NSCLC. 📊 Results: - Noninferior PK &amp; ORR: SC 30.1% vs IV 32.5% - Longer DoR, PFS, OS:SC &gt; IV ? - IRRs:SC 13%
Madeleine Armstrong
@ByMadeleineA
● NEUTRAL $JNJ flies towards a more convenient Rybrevant, but has a long way to go before this is a $5bn product #ASCO24 via @ApexOnco https://t.co/uYXvAR1Xqn https://t.co/mPRR6yBRXf
Bertrand Delsuc
@BertrandBio
● NEUTRAL SC vs IV amivantamab+lazertinib in refractory EGFRm adv NSCLC: Primary results incl. OS from global ph3 RCT PALOMA-3 $JNJ $GMAB $AZN #ASCO24 seemingly supporting a quick switch from IV to SC maybe slighly more effective, less toxic, more convenient
Oncology Brothers
@OncBrothers
● NEUTRAL 2. #PALOMA3: Ph 3, SC amivantamab + Laz vs IV ami + laz in mEGFR refractory mNSCLC - Less IRRs (13% vs IV 66%) - Improved VTE w/ SC - Similar ORR 3/6 https://t.co/vXM2XAqGoy https://t.co/6n7mDHc5w2
Bartomeu Massuti
@bmassutis
● NEUTRAL Amivantamab subcutaneous vs intravenous in combination with Lazertinib improves safety and tolerability in 3rd line EGFR+ NSCLC. Honored to participate in PALOMA 3 trial on behalf @GVAsalualicante Oncology Team member of @isabial_iis. Presented at #A
Jacob Plieth
@JacobPlieth
● NEUTRAL V interesting precedent from $BMY CM-67T, now seen again in $JNJ Paloma-3, where SC version actually shows numerically better survival than IV #ASCO24 https://t.co/eIiauue1cE
Benjamin Besse
@BenjaminBesseMD
● NEUTRAL S/C route is the way to go for amivantamab! Paloma 3 trial shows similar PK of S/C vs IV with potentially better survival. Dose intensity &amp; toxicities seem similar (but for Infusion relation reaction). Are blocking ADAs (anti drug antibodies) mor
● NEUTRAL 🚨Just presented @ASCO #ASCO24 VERY PROMISING RESULTS of #PALOMA-3 trial of: #Subcutaneous Vs #Intravenous #Amivantamab in combo with lazertinib, in refractory #EGFR+ advanced non-small cell #LungCancer. 👇🏼 ✅Noninferior #PK &amp; #ORR ✅⬆️#DoR, #PFS
● NEUTRAL 🚨#PALOMA3 Subq (SC) vs IV #amivantamab + Lazertinib, in Refractory EGFR+ NSCLC: ↔️ Similar PK outcomes (non-inferiority) ⬇️ infusion-related reactions (13% vs. 66%) and VTE (9% vs. 14%) ➡️ Exploratory OS analysis favors SC (HR 0.62, p=0.02) 👉🏽SC f
Mariam Alexander
@MariamAlex26
● NEUTRAL SQ Ami is a game changer simplifying delivery of Amivamtamab, reducing health care burden and is preferred by patients with 5 fold reduction in infusion related reactions #paloma3 #WCLC24 @muschollings @MUSChealth https://t.co/FzswSA4rKH
Dr Adam Januszewski
@AdamJanuszewski
● NEUTRAL PALOMA-3: Ph3 sc vs iv amivantimab in pre-treated EGFR mutant mNSCLC Curious improvement in OS in the sc arm … open discussion on theories. #ASCO24 https://t.co/vFxpRB4lS7
VJ Oncology
@VJOncology
● NEUTRAL #ASCO24 | Natasha Leighl (@pmcancercentre) discusses findings from PALOMA-3 which evaluated subcutaneous vs IV #amivantamab + #lazertinib in patients with EGFR-m advanced #NSCLC Watch here: https://t.co/csKKw8at4e 🩺The study met its co-primary endp
● NEUTRAL For US #HCPs attending #ASCO24: don’t miss Dr. Natasha Leighl present primary results from the Phase 3 PALOMA-3 study of subcutaneous EGFRxMET bispecific antibody + 3rd-gen TKI in patients with refractory EGFR-mutated advanced non-small cell #LungCan
● NEUTRAL Subcutan injection or IV infusion? Does it matter? Phas 3 PALOMA-3 says it might. Resrchers studied ami + oral laz in pts w/ adv #EGFR + NSCLC for drug effic &amp; safety. Manual subcutan injections had better PFS, DoR and pat convenience. @pmcancerc
Aya Mohamed, MD MSc
@Dr_Oncologista
● NEUTRAL PALOMA-3 trial Amivantamab SC demonstrated non-inferiority to IV presentation with favorable efficacy and safety outcomes. @OncoAlert #ASCO24 https://t.co/ApoYzMCjaS
Tom Newsom-Davis
@tnewsomdavis
● NEUTRAL Well, that is interesting… PALOMA-3: S/C vs IV Amivantamab post Osi + Chemo ✅ ⬆️ OS, HR = 0.62 ❓ ⬆️ PFS, HR = 0.84 (n/s) ✅ ⬆️ DoR But… no difference in drug discontinuation or dose reduction 🤔 Benefit from better PK, or lymphatic absorption? #
Antonio Passaro
@APassaroMD
● NEUTRAL Simply, an important &amp; big step forward that will revolutionize the future of treating EGFR-mutated NSCLC. #LungCancer #ASCO24 #LCSM https://t.co/n3QZDN1Bay
Anusha MD
@md_anusha
● NEUTRAL KEY 🔑 Takeaways aways from PALOMA- 3 trials 🫁 —Improved patient experience with SC vs IV Amivantamab —Less Infusion reactions with SC Amivantamab —Less VTE with SC Amivantamab #ASCO24 @ASCO
Oncology Learning Network
@OncLearnNetwork
● NEUTRAL At #ASCO24, Natasha Leighl, MD, @pmcancercentre, presented results from the phase 3 PALOMA-3 trial which compared subcutaneous and intravenous amivantamab plus lazertinib in patients with advanced, EGFR-mutated NSCLC. Watch the video: https://t.co/ur
Johan Pluvy
@johanpluvy
● NEUTRAL PALOMA-3 Phase III Amivantamab SC versus IV + Lazertinib dans les 2 bras en progression après Osimertinib et doublet chimiothérapie Amélioration de la Survie HR=0,62, DoR et PFS en faveur de la forme SC #ASCO24
Keith Stewart
@akeithstewart
● NEUTRAL @MAWildgust @pmcancercentre Dr Natasha Leighl presenting an advance in lung cancer treatment developed by @JanssenUS (J&amp;J)
Crispin Hiley
@crispinhiley
● NEUTRAL @AdamJanuszewski Dose intensity (less infusion reactions), so total dose is higher?
Marcelo Corassa, MD.
@MarceloCorassa
● NEGATIVE PALOMA-3 shows that SC Ami is better, but it still not a walk in the park. Non-inferior efficacy and PK endpoints reached compared to the IV formulation. Better PFS related to dose density? Much less IRR. But still with the infamous both EGFR and MET