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EVOKE-01 Trial

2L+ NSCLC - Gilead

2L+ NSCLC Trodelvy (sacituzumab govitecan) ASCO 2024
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Top KOLs Discussing EVOKE-01

Timothe Olivier, MD
Timothe Olivier, MD
@Timothee_MD
11.2K impressions
Jacob Plieth
Jacob Plieth
@JacobPlieth
9.4K impressions
Benjamin Besse
Benjamin Besse
@BenjaminBesseMD
8.9K impressions
Hidehito HORINOUCHI
Hidehito HORINOUCHI
@HHorinouchi
7.5K impressions
Giannis Mountzios
Giannis Mountzios
@g_mountzios
5.5K impressions
Jordi Remon
Jordi Remon
@JordiRemon
5.4K impressions

EVOKE-01 Key Slides & Visuals

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

Timothe Olivier, MD
Timothe Olivier, MD @Timothee_MD
EVOKE-01 Data
11.2K impressions · 11 likes · May 31, 2024
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[Slide 1] Objective: To identify the nature and frequency of distorted presentation or "spin" (ie, specific reporting strategies, whatever their motive, to highlight that the experimental treatment is beneficial, despite a statistically nonsignificant difference for the primary outcome, or to .. .. ...
Benjamin Besse
Benjamin Besse @BenjaminBesseMD
EVOKE-01 Data
8.9K impressions · 83 likes · May 31, 2024
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[Slide 1] EVOKE-01: Global, Randomized, Open-Label, Phase 3 Study Key eligibility criteria Measurable stage IV NSCLC Sacituzumab End points ECOG PS 0-1 Primary Radiographic progression after platinum- govitecan 10 mg/kg on Days 1 and OS based and anti-PD-(L)1-containing regimenᵃ N = 603 8 of 21-day cycles Secondary In addition, patients with known AGAs R PFS, ORR, DOR, and DCR must have received ≥ 1 approved TKIb 1:1 by INV per RECIST v1.1 EGFR/ALK test required. Testing of other Docetaxel AGAs recommended 75 mg/m2 on Day 1 of Safety and tolerability Previously treated stable brain 21-day cyclesᵈ QoL using NSCLC-SAQ metastases were included Stratified by No prior treatment with Topo-1 inhibitors, Histology (squamous VS nonsquamous) Trop-2-targeted therapies, or docetaxel Response to last anti-PD-(L)1-containing regimen (responsive [best response CR/PR] VS nonresponsive [PD/SD]) Received prior targeted therapy for AGA (yes VS no) At data cutoff (29 November 2023), the study median follow-up was 12.7 months (range, 6.0-24.0) *(Neo)adjuvant therapy counted if progression within 6 months of platinum treatment and while on maintenance with checkpoint elibitor agent. any local approval exists for targeted therapy to that genomic storation Based = bcal SOC and availability of testing/approved targeted agent. Until PD or unacceptable toxicity AGA actionable genomic elteration CR, complete response, DCR disease control rate; DOR, duration of response, ECOG PS, Eastern Cooperative Oncology Group performance status; INV, investigator, NSCLC, non-smal cell lung cancer, NSCLC-SAQ Non-small Cell Lung Cancer Symptom Assessment Questionnaire, ORR objective response rate; OS, overal united PD, progressive disease, PD-(L)1, programmed death (ligand) 1,PFS, progression-free survival, PR partial response; OOL, quality of is R, randomization, RECIST n 1, Response Evaluation Citeria in Solid Tumors version 1.1.SD so stable disease, SOC, standard of care, TKI, tyrosine kinase inhibitor; Topo-1, topoisomerase-1 Trop-2, trophoblest cell surface antigen 2. 2024 ASCO #ASCO24 PRE SENTED BY: Dr. Luis G. Paz-Ares, Hospital Universitario 12 de Octubre ASCO AMERICAN security CINCAL ANNUAL MEETING Presentation N property of the author and ASCO Permission required by - carlod ENDWLEDGE CONDUERS CANCER --- [Slide 2] Overall Survival: Subgroup Analyses Subgroup Hazard ratio HR (95% CI) Overall (n = 603) 0.84 (0.68-1.04) Histology Squamous (n = 164) 0.83 (0.56-1.22) Nonsquamous (n = 439) 0.87 (0.68-1.11) Best response to last anti-PD-(L)1-containing regimen PD/SD (n = 383) 0.75 58-0 97) CR/PR (n = 219) 1.09 (0.76-1.58) Received prior therapy for AGA No (n = 559) 0.89 (0.72-1.11) Yes (n = 44) 0.52 (0.22-1.23) Age group 0.80 (0.59-1.08) < 65 years (n = 297) 0.90 (0.68-1.20) ≥ 65 years (n = 306) Baseline ECOG PS 1.06 (0.70-1.60) 0 (n = 190) 0.81 (0.64-1.04) 1 (n = 410) 0.125 0.25 0.5 1 2 4 8 AGA, actionable genomic alteration, Cl, confidence interval, CR, complete response, ECOG PS, Eastern Cooperative Oncology Group performance status, HR, hazard retio, PD, progressive disease, PD-4)1. programmed - (igand) '' PR, partial response, SD, stable disease ASCO i B I 2024 ASCO PRESENTED BY: Dr. Luis G. Paz-Ares, Hospital Universitario 12 de Octubre UNIOL #ASCO24 ENDWLEDGE CONDUERS CANCER - --- [Slide 3] ICARUS ICARUS-Lung01 LUNG Study Design Multi-center, single-arm, phase 2 study (NCT04940325) KEY ELIGIBILITY CRITERIA NSCLC (stage IIIB, IIIC, or IV) Primary Endpoint: ECOG PS of 0 or 1 Investigator-assessed ORR* Progressed on prior 1-3 lines: Dato-DXd 6 mg/kg Q3W Without known mutations: anti PD-1/PDL-1 containing therapy and a platinum-doublet regimen until PD or unacceptable toxicity Secondary Endpoints: With known EGFR, BRAF, MET ALK, ROS1, RET DOR, PFS, CBR, OS NTRK alterations: one line of an approved targeted agent and one platinum-doublet regimen Safety and tolerability Asymptomatic brain metastases Baseline C1D3 EOT Exploratory Endpoints: Mandatory sample collection : Or C2D3 Predictors of response/resistance Tumor biopsy (1 Frozen + 3 FFPE) Dynamics of TROP2 expression Blood (5 to 69 ml) before and after treatment CTCs levels during treatment ECOG PS: Eastern Cooperative Oncology Group Performance Status, FFPE: Formalin-Fixed Paraffin-Embedded, Q3W every 3 weeks, PD: Progressive Disease, C Cycle, D. Day, EOT End of Treatment, ORR: Objective Response Rate, DOR: Duration of Response, CBR: Clinical Benefit Rate, CTCs: Circulating Tumor Cells . Confirmed ORR as per RECIST V1.1 assessment every 6 weeks until objective progressive disease 2024 ASCO PRE SENTED BY: D. Planchard, MD, PhD ASCO AUTHOR exempt CINCAL #ASCO24 ANNUAL MEETING Presentation a property of the ACO and ASCO Permission required for - order DISCOUNT CONDUERS CANCER --- [Slide 4] ORR: overall population and by subgroups ICARUS LUNG 80 Histology Non-Squamous Squamous Overall population, N=100 Confirmed ORR, % 26.0 60 [95%CI] [17.4 : 34.6] 40 DOR, median (months) 7.0 [95%CI] [5.5;11.9] 20 36 Change from baseline (%) CBRᵇ, % 0 [95%CI] [26.6 45.4] -20 ORR by histology (N=100)/genomic alterations (N=85) -40 ORR by NSQ (N=82) SCC (N=18) histology, % 30.5 5.6 -60 [95%CI] [20.8;41,6] [0.14:27.3] ORR by EGFR, Present (N=12) Absent (N=73) -80 BRAF mut, % 50.0 23.2 [95%CI] [21.1;78.9] (14.2;34.7) -100 *11 Patients with EGFR and 1 BRAFV600E alterations HO po <10% is rejected, P value< 0001 Patient KRAS mut (N=11) ORR: 63.6% [30.8; 89.1%] KRAS wt (N=74) ORR: 81.6% [12.9; 32.7%) NSQ: Non-Squamous Cell Carcinoma "Confirmed ORR; clopper-Pearson (Exact) method was used for confidence interval; Defined as the presence of ≥ 1 partial or complete response, or 8 stable disease for >6 months under treatment, 111 EGFR: exon 19, 20, 21; 1 BRAFV600E; KRAS G12C (n=7) ASCO - 2024 ASCO PRE SENTED BY: D. Planchard, MD, PhD GNICK #ASCO24 ENOMLEDGE CONDUERS CANCER ANNUAL MEETING Presentation # property of the author and ASCO Permission required for - contact
Hidehito HORINOUCHI
Hidehito HORINOUCHI @HHorinouchi
EVOKE-01 Data
6.6K impressions · 25 likes · Jun 01, 2024
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[Slide 1] Trial TROPION-Lung01 EVOKE-01 Primary endpoint PFS & OS OS Drugs Datopotomab Deruxtecan Docetaxel Sacituzumab Govitecan Docetaxel No of Patients 299 305 299 304 Median F/U 10.9m 9.6m 12.7m ORR 26.4% 12.8% 13.7% 18.1% DOR 7.1m 5.6m 6.7m 5.8m PFS 4.4m 3.7m 4.1m 3.9m PFS HR 0.75 (0.62-0.91) 0.92 (0.77-1.11) PFS Sq 2.8m 3.9m 3.8m 3.9m PFS Sq HR 1.38 (0.94-2.02) 0.94 (0.67-1.32) PFS NonSq 5.6m 3.7m 4.1m 4.0m PFS NonSq HR 0.63 (0.51-0.78) 0.93 (0.75-1.15) OS 12.4m 11.0m 11.1m 9.8m OS HR 0.90 (0.72-1.13) 0.84 (0.68-1.04) TRAEs ≥G3 25% 41% 52.7% 60.1% Stomatitis, any 54% 20% 13.2 20.1 ILD, any 8% 4% NA NA TRD 2% 0.3% 1.4% 1.0% Payload Deruxtecan (topo-I) NA SN-38 (topo-I) NA DAR 4 NA 7.6 NA Antibody IgG1 NA IgG1 NA Linker Tetrapeptide based cleavable NA Hydrolysable pH sensitive linker NA ClinicalTrial.gov NCT04656652 NCT05089734
Giannis Mountzios
Giannis Mountzios @g_mountzios
EVOKE-01 Data
5.5K impressions · 26 likes · May 31, 2024
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[Slide 1] ASCO Abstract LBA8500 2024 ANNUAL MEETING 2024 ASCO Annual Meeting, May 31 - June 4, 2024, Chicago, IL, USA Sacituzumab Govitecan vs Docetaxel in Patients With Metastatic Non-small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy and PD-(L)1 Inhibitors: Primary Results From the Phase 3 EVOKE-01 Study Luis G. Paz-Ares, MD, PhD,¹ Oscar Juan-Vidal, MD,2 Giannis S. Mountzios, MD, PhD,³ Enriqueta Felip, MD, PhD,4 Niels Reinmuth, MD,⁵ Filippo de Marinis, MD, PhD,6 Nicolas Girard, MD, PhD,⁷ Vipul M. Patel, MD,8 Takayuki Takahama, MD, PhD,9 Scott P. Owen, MD,¹⁰ Douglas M. Reznick, MD,¹¹ Firas B. Badin, MD,¹² Irfan Cicin, MD,¹³ Sabeen Mekan, MD,14 Riddhi Patel, PharmD,14 Eric Zhang, PhD,¹⁴ Divyadeep Karumanchi, PharmD,14 Marina Chiara Garassino, MD¹⁵ "Hospital Universitario 12 de Octubre, H120-CNIO Lung Cancer Unit, Complutense University and Ciberonce University and Ciberonc, Madrid, Spain; Hospital Universitari Politecnic La Fe de Valencia, Valencia, Spain; PHenry Dunant Hospital Center, Athens, Greece; "Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain; Asklepios Lung Clinic, German Center for Lung Research (DZL), Munich-Gauting, Germany, European Institute of Oncology IRCCS, Milan, Italy; Institut du Thorax Curie Montsouris, Institut Curie, Paris, France; Florida Cancer Specialists and Research Institute, Ocala, FL, USA; *Kindai University, Osaka, Japan; "McGill University Health Centre, Montreal, Quebec, Canada; "Rocky Mountain Cancer Center, Aurora, CO, USA; Baptist Health Medical Group, Lexington, KY, USA: Pistinye University, Medical Center, Istanbul, Turkey, "Gilead Sciences, Inc, Foster City, CA, USA; University of Chicago Comprehensive Cancer Center, Chicago, IL, USA 2024 ASCO #ASCO24 PRESENTED IV: Dr. Luis G, Paz-Ares, Hospital Universitario 12 de Octubre ANNUAL MEETING ASCO INCOME I 8 CURRICAL DRICOLOGY Presentation property - and ABCD - - for - - KNOWLEDGE CONQUERS CANCER --- [Slide 2] Primary End Point: Overall Survival (ITT) SG Docetaxel 100 (n = 299) (n = 304) 90 Median, months (95% CI) 11.1 (9.4-12.3) 9.8 (8.1-10.6) 80 HR (95% CI) 0.84 (0.68-1.04) 1-sided P-value 0.0534 70 12-month OS rate, % 46.59 36.72 os probability (%) 60 (95% CI) (40.45-52.50) (30.88-42.57) 1-sided P-value for significance was Ps 0.0223 50 46.6% 40 30 36.7% 20 10 SG Docetaxel 0 0 2 4 6 8 10 12 14 16 18 20 Patients still at risk, N (events) Time (months) SG 299 (0) 275 (23) 234 (63) 212 (83) 175 (112) 140 (137) 76 (150) 40 (162) 17 (166) 10 (167) 0 (168) Docetaxel 304 (0) 277 (23) 234 (65) 201 (98) 158 (131) 128 (151) 64 (178) 41 (184) 15 (187) 7 (187) 2 (187) CI, confidence interval, HR, hazard ratio, ITT, intent-to-treat; OS, overall survival; SG, sacituzumab govitecan. 2024 ASCO #ASCO24 PRESENTED BT: Dr. Luis G. Paz-Ares, Hospital Universitario 12 de Octubre ASCO AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING Presentation a property of the author and ASCO Permission required for reuse, contact cermissions@asco org. KNOWLEDGE CONQUERS CANCER --- [Slide 3] Overall Survival: Best Response to Last Anti-PD-(L)1-Containing Regimen SG had a 3.5-month median os improvement over docetaxel among subgroups with nonresponsive (SD/PD) disease Nonresponsive (SD/PD) Responsive (CR/PR) 100 100 SG Docetaxel SG Docetaxel 90 (n=192) (n=191) 90 (n = 106) (n=113) 80 Median, months 11.8 8.3 80 Median, months 9.6 10.6 (95% CI) (9.6-12.5) 0-10.6) (95% CI) (8.1-14.4) 70 (8.9-12.8) 70 os probability (%) HR (95% CI) 0.75 (0.58-0.97) 50 os probability (%) HR (95% CI) 1.09 (0.76-1.56) 60 60 47.7% 50 44.0% 40 40 41.2% 30 30 34.0% 20 20 SG 10 SG 10 Docetaxel Docetaxel 0 0 0 2 4 6 8 10 12 14 16 18 20 0 2 4 6 8 10 12 14 16 18 20 Patients still at risk, N (events) Time (months) Patients still at risk, N (events) Time (months) SG 192(0) 175(16) 149(41) 135(54) 116(72) (8(84) 53(95) 26(105) 11(107) 8(107) 0(108) SG 106(0) 99(7) 84(22) 76(29) 58(40) 41 (53) 22(55) 14(57) 6(50) 2(60) 0(60) Docetaxel 101(0) 175(14) 141(47) 118(70) 95(91) 78(103) 36(119) 21(124) 6(126) 3(126) 0(126) Docetaxel 113(0) 102(9) 93(18) 83(28) 63(40) 50(48) 28(59) 20(60) 9(61) 4(61) 2(61) CL, confidence interval, CR complete response, HR, hazard ratio; OS, overall survival, PD, progressive disease; PD-(L)1, programmed death (ligand) 1; PR, partial response; SD, stable disease, SG, sacituzumab govitecan 2024 ASCO #ASCO24 PRESENTED BY: Dr. Luis G. Paz-Ares, Hospital Universitario 12 de Octubre ASCO AMERICAN SOCIETY OF CUNICAL ONCOLOGY ANNUAL MEETING Presentation property of the author and ASCO Permission required or ITUM contact permissions@asco.org KNOWLEDGE CONQUERS CANCER --- [Slide 4] Overall Survival: Nonresponsive (SD/PD) to Last Anti-PD-(L)1-Containing Regimen, by Histology SG had similar OS improvement over docetaxel in both nonsquamous and squamous histology Nonsquamous Squamous 100 100 SG Docetaxel SG Docetaxel 90 (n = 142) (n = 145) 90 (n = 50) (n = 46) 80 Median, months 11.8 8.4 80 Median, months 10.7 7.9 (95% CI) (9.4-12.6) (7.0-11.2) (95% CI) (6.9-16.0) (5.3-10.2) 70 70 OS probability (%) HR (95% CI) 0.79 (0.59-1.07) HR (95% CI) 0.62 (0.36) 1.02) 60 60 50 46.7% os probability (%) 50 49.8% 40 40 30 37.3% 30 20 20 22.4% SG SG 10 10 Docetaxel Docetaxel 0 0 0 2 4 6 8 10 12 14 16 18 20 0 2 4 6 8 10 12 14 16 18 20 Patients still at risk, N (events) Time (months) Time (months) Patients still at risk, N (events) SG 142(0) 131(11) 111(30) 101(40) 88(52) 73(62) 38(71) 19(77) 7(78) 4(78) 0(78) SG 50(0) 44(5) 38(11) 34(14) 28(20) 25(22) 15(24) 7(28) 4(29) 4(29) 0(30) Docetaxel 145(0) 135(0) 109(35) 93(51) 74(68) 62(77) 30(87) 16(91) 5(92) 3(92) 0(92) Docetaxel 46(0) 40(5) 32(12) 25(19) 21(23) 16(26) 6(32) 5(33) 1(34) CI, confidence interval, HR, hazard ratio; OS, overall survival, PD, progressive disease; PD-(L)1, programmed death (ligand) 1; SD, stable disease; SG, sacituzumab govitecan. 024 ASCO #ASCO24 PRESENTED BY: Dr. Luis G, Paz-Ares, Hospital Universitario 12 de Octubre ASCO AMERICAN SOCIETY OF CUNICAL ONCOLOGY INUAL MEETING Presentation 6 property of the author and ASCO Permission required or reuse, contact permissions@asco.org KNOWLEDGE CONQUERS CANCER
Jordi Remon
Jordi Remon @JordiRemon
EVOKE-01 Data
5.4K impressions · 60 likes · May 31, 2024
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[Slide 1] Target Drug Payload Linker DAR HER3 Patritumab-DXd Topoisomerase Inhibitor Cleavable 8 Potential in EGFRm post-Osi NAM Pending HERTHENA-LUNG 02 Biomarker selection not required EVOKE-01 vs Docetaxel TROP2 Sacituzumab govitecan Topoisomerase Inhibitor Cleavable 7.6 3365 Negative for OS Tropion-LUNG01 vs Docetaxel TROP2 Datopotamab-DXd Topoisomerase Inhibitor Cleavable 4 Negative for OS (Benefit PFS) Approved by the FDA AND EMA HER2* Trastuzumab-DXd Topoisomerase Inhibitor Cleavable 8 In HER2m NSCLC (2ND Line) Biomarker selection CARMEN-LC03 vs Docetaxel CEACAM5 Tusamitamab ravtansine Microtubule Inhibitor Cleavable 3.8 Negative for PFS/OS required P Potential in EGFRm post-Osi c-Met Telisotuzumab vedotin Microtubule Inhibitor Cleavable 3.1 Pending M22-142 in MET+ 2 c-Met ABBV-400 Topoisomerase Inhibitor Cleavable - --- [Slide 2] EVOKE-01: Global, Randomized, Open-Label, Phase 3 Study Key eligibility criteria Measurable stage IV NSCLC End points Sacituzumab ECOG PS 0-1 Primary govitecan Radiographic progression after platinum- 10 mg/kg on Days 1 and OS based and anti-PD-(L)1-containing 8 of 21-day cyclesd regimenᵃ N = 603 Secondary R In addition, patients with known AGAs PFS, ORR, DOR, and DCR must have received ≥ 1 approved TKIᵇ 1:1 by INV per RECIST v1.1 Docetaxel EGFR/ALK test required. Testing of other 75 mg/m² on Day 1 of Safety and tolerability AGAs recommended Previously treated stable brain 21-day cyclesd QoL using NSCLC-SAQ metastases were included Stratified by No prior treatment with Topo-1 inhibitors, Histology (squamous VS nonsquamous) Response to last anti-PD-(L)1-containing regimen (responsive [best response Trop-2-targeted therapies, or docetaxel CR/PR] VS nonresponsive [PD/SD]) Received prior targeted therapy for AGA (yes VS no) At data cutoff (29 November 2023), the study median follow-up was 12.7 months (range, 6.0-24.0) and availability of testing/approved targeted agent Unitil PD or unacceptable toxicity AGA, actionable genomic alteration; CR, complete response, DCR, disease control rate; DOR, duration of response, ECOG PS, Eastern *(Noo)adjuvant therapy counted if progression within 6 months of platinum treatment and while on maintenance with checkpoint inhibitor agent. if local approval exists for targeted therapy to that genomic alteration Based on Cooperative local SOC Oncology Group performance status; INV, investigator, NSCLC non-small cell lung cancer, NSCLC-SAQ, Non-small Cell Lung Cancer Symptom Assessment Questionnaire: ORR, objective response rate; OS, overall survival; PD, progressive disease, PD-(L)1, programmed death (ligand) 1; PFS, progression-free survival, PR, partial response, QoL, quality of tife; R, randomization; RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.1; SD, stable disease, SOC, standard of care, TKI, tyrosine kinase inhibitor, Topo-1, topoisomerase-1; Trop-2, trophoblast cell surface antigen 2. ASCO AMERICAN SOCIETY 2024 ASCO PRESENTED BY: Dr. Luis G. Paz-Ares, Hospital Universitario 12 de Octubre CLINICAL ONCOLOG #ASCO24 KNOWLEDGE CONQUERS CANC ANNUAL MEETING Presentation a property of the euthor and ASCO Permission required for - contact permissions@asco.org --- [Slide 3] Primary End Point: Overall Survival (ITT) SG Docetaxel 100 (n . 299) (n . 304) 90 Median, months 11.1 (9.4-12.3) 9.8 (8.1-10.6) (95% CI) 80 HR (95% CI) 0.84 (0.68-1.04) 1-sided P-value 0.0534 70 12-month OS rate, % 46.59 36.72 os probability (%) 60 (95% CI) (40.45-52.50) (30.88-42.57) 1-sided P-value for significance was PS 0.0223 50 46.6% 40 30 36.7% 20 10 SG Docetaxel 0 0 2 4 6 8 10 12 14 16 18 20 Time (months) Patients still at risk, N (events) SG 299 (0) 275 (23) 234 (63) 212 (83) 175 (112) 140 (137) 76 (150) 40 (162) 17 (166) 10 (167) 0 (168) Docetaxel 304 (0) 277 (23) 234 (65) 201 (98) 158 (131) 128 (151) 64 (178) 41 (184) 15 (187) 7 (187) 2 (187) CL confidence interval, HR, hazard ratio; ITT, intent to-treat, OS, overall survival; SG, sacitumab govitecan. ASCO AMERICAN SOCIETY OF 2024 ASCO PRESENTED UT: Dr. Luis G. Paz-Ares, Hospital Universitario 12 de Octubre CLINICAL ONCOLOGY #ASCO24 KNOWLEDGE CONQUERS CANCER ANNUAL MEETING Presentation - property of the euthor and ASCO Permission required for FROM contact permissions@asco.org --- [Slide 4] Overall Survival: Subgroup Analyses Subgroup Hazard ratio HR (95% CI) Overall (n = 603) 0.84 (0.68-1.04) Histology Squamous (n = 164) 0.83 (0.56-1.22) Nonsquamous (n = 439) 0.87 (0.68-1.11) Best response to last anti-PD-(L)1-containing regimen PD/SD (n = 383) 0.75 (0.58-0.97) CR/PR (n = 219) 1.09 (0.76-1.56) Received prior therapy for AGA No (n = 559) 0.89 (0.72-1.11) Yes (n = 44) 0.52 (0.22-1.23) Age group < 65 years (n = 297) 0.80 (0.59-1.08) > 65 years (n = 306) 0.90 (0.68-1.20) Baseline ECOG PS 0 (n = 190) 1.06 (0.70-1.60) 1 (n = 410) 0.81 (0.64-1.04) 0.125 0.25 0.5 1 2 4 8 AGA actionable genomic alteration, CI, confidence interval, CR, complete response, ECOG PS, Eastern Cooperative Oncology Group performance status, HR, hazard ratio; PD, progressive disease, PD-(L)1, programmed death (ligand) 1; PR, partial response, SD, stable disease 2024 ASCO #ASCO24 PRESENTED BY BY: Dr. Luis G. Paz-Ares, Hospital Universitario 12 de Octubre ASCO AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO Permission required for Nust, contact permissions@asco.org KNOWLEDGE CONQUERS CANCER
Yakup Ergün
Yakup Ergün @dr_yakupergun
EVOKE-01 Data
4.4K impressions · 40 likes · May 31, 2024
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[Slide 1] EVOKE-01: Global, Randomized, Open-Label, Phase 3 Study Key eligibility criteria Measurable stage IV NSCLC Sacituzumab End points ECOG PS 0-1 Primary govitecan Radiographic progression after platinum- 10 mg/kg on Days 1 and OS based and anti-PD-(L)1-containing N = 603 8 of 21-day cyclesd regimenᵃ Secondary In addition, patients with known AGAs R PFS, ORR, DOR, and DCR must have received ≥ 1 approved TKIb 1:1 by INV per RECIST v1.1 EGFR/ALK test required. Testing of other Docetaxel AGAs recommended© 75 mg/m² on Day 1 of Safety and tolerability Previously treated stable brain 21-day cyclesᵈ QoL using NSCLC-SAQ metastases were included Stratified by No prior treatment with Topo-1 inhibitors, Histology (squamous VS nonsquamous) Trop-2-targeted therapies, or docetaxel Response to last anti-PD-(L)1-containing regimen (responsive [best response CR/PR] VS nonresponsive [PD/SD]) Received prior targeted therapy for AGA (yes VS no) At data cutoff (29 November 2023), the study median follow-up was 12.7 months (range, 6.0-24.0) (Neo)adjuvant therapy counted if progression within 6 months of platinum treatment and while on maintenance with checkpoint inhibitor agent. off local approval exists for targeted therapy to that genomic alteration 'Based on local SOC and availability of testing/approved targeted agent Until PD or unacceptable toxicity. AGA, actionable genomic alteration; CR, complete response, DCR, disease control rate; DOR, duration of response, ECOG PS, Eastern Cooperative Oncology Group performance status, INV. investigator, NSCLC. non-small cell lung cancer, NSCLC-SAQ Non-small Cell Lung Cancer Symptom Assessment Questionnaire; ORR, objective response rate; OS, overall survival; PD, progressive disease; PD-(L)1, programmed death (ligand) 1; PFS, progression-free survival PR, partial response; QoL. quality of life; R, randomization; RECIST v1.1. Response Evaluation Criteria in Solid Tumors version 1.1; SD, stable disease; SOC, standard of care; TKI, tyrosine kinase inhibitor; Topo-1, topoisomerase-1; Trop-2. trophoblast cell surface antigen 2. 2024 ASCO #ASCO24 PRESENTED BY Dr. Luis G. Paz-Ares, Hospital Universitario 12 de Octubre ASCO AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO Permission required for reuse, contact permissions@asco.org KNOWLEDGE CONQUERS CANCER --- [Slide 2] Primary End Point: Overall Survival (ITT) SG Docetaxel 100 (n = 299) (n = 304) 90 Median, months (95% CI) 11.1 (9.4-12.3) 9.8 (8.1-10.6) 80 HR (95% CI) 0.84 (0.68-1.04) 1-sided P-value 0.0534 70 12-month OS rate, % 46.59 36.72 os probability (%) 60 (95% CI) (40.45-52.50) (30.88-42.57) 1-sided P-value for significance was P â 0.0223 50 46.6% 40 30 36.7% 20 10 SG Docetaxel 0 0 2 4 6 8 10 12 14 16 18 20 Patients still at risk, N (events) Time (months) SG 299 (0) 275 (23) 234 (63) 212 (83) 175 (112) 140 (137) 76 (150) 40 (162) 17 (166) 10 (167) 0 (168) Docetaxel 304 (0) 277 (23) 234 (65) 201 (98) 158 (131) 128 (151) 64 (178) 41 (184) 15 (187) 7 (187) 2 (187) CI, confidence interval; HR, hazard ratio; ITT, intent-to-treat, OS, overall survival SG, sacituzumab govitecan 2024 ASCO #ASCO24 PRESENTED BY: Dr. Luis G. Paz-Ares, Hospital Universitario 12 de Octubre ASCO AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO Permission required for reuse, contact permissions@asco.org KNOWLEDGE CONQUERS CANCER --- [Slide 3] Overall Survival: Subgroup Analyses Subgroup Hazard ratio HR (95% CI) Overall (n = 603) 0.84 (0.68-1.04) Histology Squamous (n = 164) 0.83 (0.56-1.22) Nonsquamous (n = 439) 0.87 (0.68-1.11) Best response to last anti-PD-(L)1-containing regimen PD/SD (n = 383) 0.75 (0.58-0.97) CR/PR (n = 219) 1.09 (0.76-1.56) Received prior therapy for AGA No (n = 559) 0.89 (0.72-1.11) Yes (n = 44) 0.52 (0.22-1.23) Age group < 65 years (n = 297) 0.80 (0.59-1.08) ≥ 65 years (n = 306) 0.90 (0.68-1.20) Baseline ECOG PS 0 (n = 190) 1.06 (0.70-1.60) 1 (n = 410) 0.81 (0.64-1.04) 0.125 0.25 0.5 1 2 4 8 AGA actionable genomic alteration; CI, confidence interval; CR, complete response, ECOG PS, Eastern Cooperative Oncology Group performance status; HR, hazard ratio; PD, progressive disease; PD-(L)1, programmed death (ligand) 1: PR, partial response, SD, stable disease 2024 ASCO #ASCO24 PRESENTED BY: Dr. Luis G. Paz-Ares, Hospital Universitario 12 de Octubre ASCO AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO Permission required for reuse, contact permissions@asco.org KNOWLEDGE CONQUERS CANCER
Eric K. Singhi, MD
Eric K. Singhi, MD @lungoncdoc
EVOKE-01 Data
4.0K impressions · 13 likes · May 31, 2024
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[Slide 1] 2:45 PM-5:45 PM Oral Abstract Session Lung Cancer-Non-Sma Cell Metastatic Location: Arie Crown Theater Ticiana Leal, MD-Chair Winship Cancer Institute at Emory University Sarah B. Goldberg, MD-Chair Yale School of Medicine 2:45 PM Abstract LBA8500: Sacituzumab govitecan (SG) vs docetaxel (doc) in patients (pts) with metastatic non- small cell lung cancer (mNSCLC) previously treated with platinum (PT)-based chemotherapy (chemo) and PD(L)-1inhibitors (IO): Primary results from the phase 3 EVOKE-01 study. First Author: Luis G. Paz-Ares, PhD 2:57 PM Abstract 8501: ICARUS-LUNG01: A phase 2 study of datopotomab deruxtecan (Dato-DXd) in patients with previously treated advanced non-small cell lung cancer (NSCLC), with sequential tissue biopsies and biomarkers analysis to predict treatment outcome. First Author: David Planchard, MD, PhD 3:09 PM Abstract 8502: Sacituzumab tirumotecan (SKB264/ MK-2870) in combination with KL-A167 (anti-PD-L1) as first-line treatment for patients with advanced NSCLC from the phase II OptiTROP-Lung01 study. First Author: Wenfeng Fang, MD, PhD 3:21 PM Egbert F. Smit, MD, PhD Leiden University Medical Centre Discussion of Abstract(s) LBA8500-8502: Managing Expectations With Antibody-Drug Conjugates in Non- Small Cell Lung Cancer 3:33 PM Panel Question and Answer
Ana I. Velzquez Maana, MD MSc (she/her/ella)
EVOKE-01 Data
2.7K impressions · 17 likes · May 31, 2024
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[Slide 1] Primary End Point: Overall Survival (ITT) SG Docetaxel 100 (n = 299) (n = 304) Median, months 90 11.1 (9.4-12.3) 9.8 (8.1-10.6) (95% CI) HR (95% CI) 0.84 (0.68-1.04) 80 1-sided P-value 0.0534 70 12-month os rate, % 46.59 36.72 (95% CI) (40.45-52.50) (30.88-42.57) 60 1-sided P-value for significance was P S 0.0223 46.6% 50 40 30 36.7% 20 10 SG Docetaxel 0 8 10 12 14 16 18 20 0 2 4 6 Time (months) Patients still at risk, N (events) SG 299 (0) 275 (23) 234 (63) 212 (83) 175 (112) 140 (137) 76 (150) 40 (162) 17 (166) 10 (167) 0 (168) 304 (0) 277 (23) 234 (65) 201 (98) 158 (131) 128 (151) 64 (178) 41 (184) 15 (187) 7 (187) 2 (187) Docetaxel CI, confidence interval HR, hazard ratio; ITT. intent-to-treat OS, overall survival SG, sacituzumab govitecan ASCO AMERICAN SOCIETY OF CLINICAL ONCOLOGY PRESENTED BY: Dr. Luis G. Paz-Ares, Hospital Universitario 12 de Octubre ASCO KNOWLEDGE CONQUERS CANCER 2024 #ASCO24 Presentation is property of the author and ASCO Permission required for reuse contact permissions@asco.org ANNUAL MEETING --- [Slide 2] Secondary End Points (ITT) Progression-free Survival Objective Response Rate 100 SG Docetaxel SG Docetaxel 90 (n = 299) (n = 304) (n = 299) (n = 304) 80 Median, months 4.1 (3.0-4.4) 3.9 (3.1-4.2) ORR, % (95% CI) 13.7 (10.0-18.1) 18.1 (13.9-22.9) (95% CI) 70 DCR, % (95% CI) 67.6 (61.9-72.8) 67.1 (61.5-72.4) HR 0.92 (0.77-1.11) (95% CI) Median DOR, months 60 (95% CI) 6.7 (4.4-9.8) 5.8 (4.1-8.3) DOR rate at 6 months, % 50 (95% CI) 52.5 (35.6-66.9) 46.5 (31.9-59.8) 40 30 20 10 SG Docetaxel 0 0 2 4 6 8 10 12 14 16 18 20 Patients still at risk, N (events) Time (months) SG 299 (0) 201 (84) 143 (139) 89 (187) 66 (208) 32 (228) 15 (235) 6 (238) 2 (238) 0 (238) Docetaxel 304 (0) 190 (81) 124 (138) 72 (181) 46 (203) 22 (220) 10 (224) 5 (226) 2 (227) 2 (227) 2 (227) By INV assessment CI, confidence interval; DCR disease control rate; DOR duration of response HR hazard ratio; INV. investigator, ITT. intent-to-treat ORR objective response rate; PFS, progression-free survival; SG, sacituzumab govitecan 2024 ASCO PRESENTED BY: Dr. Luis G. Paz-Ares, Hospital Universitario 12 de Octubre ASCO AMERICAN SOCIETY OF #ASCO24 CLINICAL ONCOLOGY ANNUAL MEETING Presentation is property of the author and ASCO Permission required for reuse contact org KNOWLEDGE CONQUERS CANCER

EVOKE-01 Top Tweets

Top 10 by impressions - click to view on X

Timothe Olivier, MD
Timothe Olivier, MD@Timothee_MD

Such level of spin in the published conclusion!! @JCO_ASCO ❗️ We predicted it👇

👁 11.2K ♡ 11 ↻ 2 May 31, 2024
Benjamin Besse
Benjamin Besse@BenjaminBesseMD

Two new studies support the hypothesis that pts with EGFR mutated NSCLC are the best population for TROP-2 ADCs: EVOKE-01 (EGFR is in the ‘AGA’ subgroup in the forest plot) and ICARUS-LUNG....

👁 8.9K ♡ 83 ↻ 34 May 31, 2024
Jacob Plieth
Jacob Plieth@JacobPlieth

$GILD&#x27;s Trodelvy double whammy sees Evoke-01 underwhelm at #ASCO24 the day after Tropics-04 fails to confirm bladder cancer benefit. Via @ApexOnco...

👁 7.2K ♡ 22 ↻ 12 May 31, 2024
Hidehito HORINOUCHI
Hidehito HORINOUCHI@HHorinouchi

🔍Sport the difference🔎 🔥TROPION-Lung01 ✅PFS HR 0.75 (0.62-0.91)☀️ ✅OS HR 0.90 (0.72-1.13)🌧️ ✅"Clinically meaningful OS📈" 🔥EVOKE-01 ✅PFS HR 0.92 (0.77-1.11)🌧️ ✅OS HR 0.84...

👁 6.6K ♡ 25 ↻ 9 Jun 01, 2024
Giannis Mountzios
Giannis Mountzios@g_mountzios

#ASCO24 EVOKE-01 on SG vs Docetaxel in 2L NSCLC ✔️Negative for primary endpoint of OS ✔️&gt;3m OS benefit in pts non-responsive to prior ICI ✔️Similar benefit across...

👁 5.5K ♡ 26 ↻ 15 May 31, 2024
Jordi Remon
Jordi Remon@JordiRemon

EVOKE-01 sacituzumab govitecan vs Docet in 2L is ⛔️for OS.« Traffic light »🚦of ADCs in NSCLC is red. New biomarkers as targets for ADCs (current are prognostic), better safety of ADCs and explore mec...

👁 5.4K ♡ 60 ↻ 24 May 31, 2024
Yakup Ergün
Yakup Ergün@dr_yakupergun

#ASCO24 EVOKE-01 study: SG vs docetaxel mPFS➡️4.1 vs 3.9 mo (NS) mOS➡️11.1 vs 9.8 mo (NS) 💥SG was not superior to docetaxel in patients previously receiving platinum and...

👁 4.4K ♡ 40 ↻ 16 May 31, 2024
Eric K. Singhi, MD
Eric K. Singhi, MD@lungoncdoc

Happening NOW: mNSCLC Oral Abstracts Emerging Antibody-Drug Conjugates 🔹EVOKE-01: Phase 3 sacituzumab govitecan v docetaxel 🔸ICARUS-LUNG01: Phase 2 Dato-DXd 🔹OptiTROP-Lung01: Phase 2 1L sacituzumab...

👁 4.0K ♡ 13 ↻ 5 May 31, 2024
Christine Lovly, MD, PhD
Christine Lovly, MD, PhD@christine_lovly

⬇️ EVOKE-01: negative study overall but potential signal for TROP2 ADC SG in pts who had SD or PD as prior best response to IO. We need to understand dynamic + longitudinal nature of TROP2...

👁 2.9K ♡ 17 ↻ 13 May 31, 2024
Ana I. Velzquez Maana, MD MSc (she/her/ella)
Ana I. Velzquez Maana, MD MSc (she/her/ella)@AnaVManana

Dr. @LuisPaz_Ares presents EVOKE-01 results Sacituzumab govitecan vs docetaxel in 2L mNSCLC Sacituzumab does not meet primary end-point of statistically sig OS or PFS benefit, but mild...

👁 2.7K ♡ 17 ↻ 10 May 31, 2024

About the EVOKE-01 Trial

EVOKE-01 is a Phase III, global, multi-center, open-label trial that evaluated sacituzumab govitecan (Trodelvy) versus docetaxel in patients with previously treated advanced or metastatic NSCLC. The trial enrolled 603 patients randomized 1:1 whose cancer had progressed on or after platinum-based chemotherapy and checkpoint inhibitor therapy. EVOKE-01 did not meet its primary endpoint of overall survival, showing a numerical but not statistically significant improvement (HR 0.84; p=0.0534). Following discussions with regulators, Gilead formally discontinued development of sacituzumab govitecan in second-line-plus NSCLC.

Trial Methodology & Results

Study Design

Phase III, global, multi-center, open-label, 1:1 randomized trial comparing sacituzumab govitecan 10 mg/kg IV on days 1 and 8 of a 21-day cycle versus docetaxel IV on day 1 of a 21-day cycle. Treatment continued until disease progression or unacceptable toxicity. No companion diagnostic was required.

Population

Adults aged 18+ with stage IV NSCLC (squamous or non-squamous) that had progressed after at least one platinum-containing chemotherapy and at least one anti-PD-(L)1 immunotherapy for advanced or metastatic disease. Patients with actionable genomic alterations must have also received approved targeted therapy. Enrolled 603 patients between November 2021 and May 2023.

Interventions

Sacituzumab govitecan (Trodelvy) 10 mg/kg IV on days 1 and 8 of each 21-day cycle (n=299) versus docetaxel IV on day 1 of each 21-day cycle (n=304).

Primary Endpoints

Primary endpoint: overall survival (OS). Key secondary endpoints: progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), disease control rate (DCR), and safety. Patient-reported outcomes included time to first deterioration in shortness of breath (NSCLC-SAQ).

Progression-Free Survival (PFS)

Sacituzumab govitecan did not demonstrate a statistically significant PFS benefit versus docetaxel. Median PFS was 4.1 months (95% CI: 3.0-4.4) versus 3.9 months (95% CI: 3.1-4.2), with an HR of 0.92 that was not statistically significant. Six-month PFS rates were 33.7% versus 31.4%. PFS results were consistent with the lack of meaningful separation between arms.

PFS HR 0.92 — not significant

Source: JCO Publication (Paz-Ares et al.)

Overall Survival (OS)

The primary OS endpoint was not met. Median OS was 11.1 months for sacituzumab govitecan versus 9.8 months for docetaxel (HR 0.84; 95% CI: 0.68-1.04; one-sided p=0.0534). Twelve-month OS rates were 46.6% versus 36.7%. A pre-specified (but not alpha-controlled) subgroup of patients non-responsive to prior anti-PD-(L)1 therapy showed median OS of 11.8 versus 8.3 months (HR 0.75; 95% CI: 0.58-0.97), but survival curves crossed multiple times and the confidence interval upper bound was close to 1.00. Gilead attempted to pursue regulatory filing based on this subgroup but the FDA declined to support it.


Source: JCO - EVOKE-01 Primary Analysis

Safety & Tolerability

The safety profile was consistent with prior sacituzumab govitecan studies. Grade 3+ treatment-related AEs occurred in 66.6% of SG patients. Key toxicities: neutropenia 37.5% any grade (Grade 3+ 24.7%, vs 37% for docetaxel), diarrhea 52.7% any grade (Grade 3+ 10.5%, vs 4% docetaxel), fatigue 56.8% (Grade 3+ 12.5%), febrile neutropenia 7.8%. Treatment discontinuation due to AEs was lower with SG (9.8-10%) versus docetaxel (16.7-17%), though dose pauses were more frequent (58% vs 28%). Treatment-related deaths: 3.4% SG versus 4.5% docetaxel.

Lower discontinuation (10% vs 17%) despite more dose pauses

Source: ClinicalTrials.gov

Clinical Implications

EVOKE-01 represents a high-profile failure for the TROP2-directed ADC class in NSCLC. Despite a numerical OS trend favoring sacituzumab govitecan, the trial missed statistical significance and the 1.3-month absolute benefit lacks clinical meaningfulness. Docetaxel actually outperformed on ORR (18.1% vs 13.7%). Gilead has discontinued further evaluation of Trodelvy in 2L+ NSCLC. The result contrasts with datopotamab deruxtecan (Tropion-Lung01), which showed PFS benefit in non-squamous histology. Gilead continues to pursue Trodelvy in 1L NSCLC combinations (EVOKE-02/EVOKE-03 with pembrolizumab).

EVOKE-01 in the News

Key KOL Sentiments - EVOKE-01

DoctorSentimentComment
Carlos Martnez
@AdvCardioTech
● POSITIVE @BenjaminBesseMD @dplanchard @EGFRResisters Thanks for the detailed breakdown of EVOKE-01 and ICARUS-LUNG. Particularly encouraging to see promising results for TROP-2 ADCs in the EGFR-mutated subgroup. #ASCO24
Daniel Wang
@ethictechdan
● POSITIVE @StephenVLiu @JCO_ASCO Fascinating insights, Stephen. Despite missing the OS endpoint, the improvements in subgroups, especially the 0.75 HR in IO nonresponsive patients, are notable.
Yves Morin
@YMorinTech
● POSITIVE @StephenVLiu @LuisPaz_Ares Thank you for sharing, Stephen. Though EVOKE-01 didn't meet the OS endpoint, understanding these results is vital to refining NSCLC treatments. Important insights. #ASCO24
Timothe Olivier, MD
@Timothee_MD
● NEUTRAL Such level of spin in the published conclusion!! @JCO_ASCO ❗️ We predicted it👇 https://t.co/LZJjfz9L64 https://t.co/MovxQfbyPu https://t.co/u7Qh3dFd05
Benjamin Besse
@BenjaminBesseMD
● NEUTRAL Two new studies support the hypothesis that pts with EGFR mutated NSCLC are the best population for TROP-2 ADCs: EVOKE-01 (EGFR is in the ‘AGA’ subgroup in the forest plot) and ICARUS-LUNG. @dplanchard @EGFRResisters #ASCO24 https://t.co/C3m8TsdgO3
Jacob Plieth
@JacobPlieth
● NEUTRAL $GILD's Trodelvy double whammy sees Evoke-01 underwhelm at #ASCO24 the day after Tropics-04 fails to confirm bladder cancer benefit. Via @ApexOnco -&gt; https://t.co/OqjVFFJubk
Hidehito HORINOUCHI
@HHorinouchi
● NEUTRAL 🔍Sport the difference🔎 🔥TROPION-Lung01 ✅PFS HR 0.75 (0.62-0.91)☀️ ✅OS HR 0.90 (0.72-1.13)🌧️ ✅"Clinically meaningful OS📈" 🔥EVOKE-01 ✅PFS HR 0.92 (0.77-1.11)🌧️ ✅OS HR 0.84 (0.68-1.04)🌧️ ✅"Numerical📈in OS" 🪞Similarity: Seeking forte in subgroup #ASCO24
Giannis Mountzios
@g_mountzios
● NEUTRAL #ASCO24 EVOKE-01 on SG vs Docetaxel in 2L NSCLC ✔️Negative for primary endpoint of OS ✔️&gt;3m OS benefit in pts non-responsive to prior ICI ✔️Similar benefit across histology Happy to have offered this option in my pts!! #LCSM #some @ASCO @myESMO
Jordi Remon
@JordiRemon
● NEUTRAL EVOKE-01 sacituzumab govitecan vs Docet in 2L is ⛔️for OS.« Traffic light »🚦of ADCs in NSCLC is red. New biomarkers as targets for ADCs (current are prognostic), better safety of ADCs and explore mec of resistance, combos? may help to set up ADC as
Yakup Ergün
@dr_yakupergun
● NEUTRAL #ASCO24 EVOKE-01 study: SG vs docetaxel mPFS➡️4.1 vs 3.9 mo (NS) mOS➡️11.1 vs 9.8 mo (NS) 💥SG was not superior to docetaxel in patients previously receiving platinum and ICI Presented by dr. Luis G. Paz-Ares @OncoAlert https://t.co/xi9VsCBki9 ht
Eric K. Singhi, MD
@lungoncdoc
● NEUTRAL Happening NOW: mNSCLC Oral Abstracts Emerging Antibody-Drug Conjugates 🔹EVOKE-01: Phase 3 sacituzumab govitecan v docetaxel 🔸ICARUS-LUNG01: Phase 2 Dato-DXd 🔹OptiTROP-Lung01: Phase 2 1L sacituzumab tirumotecan + KL-A167 (anti-PD-L1) @ASCO @OncoAl
Christine Lovly, MD, PhD
@christine_lovly
● NEUTRAL ⬇️ EVOKE-01: negative study overall but potential signal for TROP2 ADC SG in pts who had SD or PD as prior best response to IO. We need to understand dynamic + longitudinal nature of TROP2 expression + trafficking. #ASCO24 @oncoalert https://t.co/vL
● NEUTRAL Dr. @LuisPaz_Ares presents EVOKE-01 results Sacituzumab govitecan vs docetaxel in 2L mNSCLC Sacituzumab does not meet primary end-point of statistically sig OS or PFS benefit, but mild numerical signal #ASCO24 #LCSM #MedscapeFellows https://t.co/U
Tom Newsom-Davis
@tnewsomdavis
● NEUTRAL EVOKE-01: Sacituzumab govitecan v Doce 2L NSCLC ❌ mOS benefit (9.8 v 11.1m) ❌ mPFS benefit ❓ ⬆️ benefit if non-responsive to last anti-PD1 regimen ✅ ⬆️ benefit in EGFRmut ✅ Better QoL 🤔 Another TROP2 disappointment 🤔 Combination 1L studies pending
Erman Akkus
@Erman_Akkus
● NEUTRAL 💊Advanced NSCLC: 2 studies in @JCO_ASCO #ASCO24 ➡️Sacituzumab govitecan vs. docetaksel (EVOKE-01) ❌Negative study Primary end point OS was not met 11.1 v 9.8 mo. HR: 0.84 (0.68 to 1.04) ➡️Lorlatinib vs Crizotinib (CROWN, 5 years of follow-up) ✅mP
Bertrand Delsuc
@BertrandBio
● NEUTRAL Also that makes $GILD feel less alone about EVOKE-01 miss on OS ("numerical improvement in OS favoring SG in the study, incl. in pts with both sq and nonsq histology"). We'll see @ #ASCO24 but abstract still embargoed for now https://t.co/Tf3RRs4gQK
● NEUTRAL #ASCO24 Packed room for oral abstracts presentation #EVOKE-01 Sacituzumab Govitecan vs docetaxel 2L ➡️Negative trial but numerical diff mOS 11.1 vs 9.8 mos did not meet OS in ITT population (HR 0.84) ➡️subgroup benefit in pts who did not benefit from
Devika Das, MD, MSHQS
@DevikaDasMD
● NEUTRAL EVOKE-01 My brief take: will not be changing clinical practice as of now #lcsm #ASCO24 @ASCO https://t.co/rjoehzdrAO
Julien Mazieres
@JulienMazieres
● NEUTRAL Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced NSCLC (EVOKE-01). Docetaxel not yet displaced despite favorable efficacy and safety profile of SG. #ASCO24 https://t.co/qQTWAcYEMM
Shankar Siva
@_ShankarSiva
● NEUTRAL @LuisPaz_Ares 🇪🇸presents EVOKE-01 ADC of sacituzumab govitecan in previously treated #lungcancer at #ASCO24. No significant difference in OS, but improvement in PROs. Some signal that those patients non-responsive to IO might benefit more. #lcsm http
Dr Riyaz Shah
@DrRiyazShah
● NEUTRAL EVOKE 01; Sacituzumab govitecan; open label P3 vs docetaxel in pretreated pts; complex hierarchical stat design. Median 5 cycles given. Mild non significant OS signal #ASCO24 https://t.co/G0H9WciIxG
Antonio Passaro
@APassaroMD
● NEUTRAL #ASCO24 EVOKE-01… ❌🔨 Learning from subgroups can provide deeper insights for the future…but for now, too many open questions…for a negative trial! https://t.co/CrNRnfrRhR
trendwhizo
@trendwhizo
● NEUTRAL $GILD will include primary results from the global Phase III EVOKE-01 study of Trodelvy (sacituzumab govitecan-hziy) in people with advanced or metastatic non-small cell lung cancer (NSCLC). #ASCO24 #cancer #OncoDaily
● NEUTRAL @PTarantinoMD @LungCancerRx @RManochakian @JackWestMD @lungoncdoc @FawziAbuRous @DevikaDasMD Oh, we got hot #ADCs too! #EVOKE-01 being presented for #sacituzumab govitecan, but for no. 4️⃣ we have a subq bispecific! Beat that! ➡️PALOMA-3: SC vs IV
Balazs Halmos
@BalazsHalmosMD
● NEUTRAL @RManochakian @OncoAlert @JCO_ASCO @ASCO EVOKE-01….what it evokes is early era of EGFR targeting…disappointing/confusing data+ here the sq-nonsq difference is not seen as compared to Dato-dxd. For Trop2 ADCs to make larger impact we’ll need to find
Bassem Morsi
@NextGenHC_BM
● NEUTRAL @HHorinouchi @OncoAlert Notable contrasts in PFS and OS between TROPION-Lung01 and EVOKE-01. Subgroups could provide more clarity. #LCSM #ESMO23 #ASCO24
Jos Sandoval
@JLSandoval
● NEUTRAL @SuyogCancer Where are the interaction p's? None of the subgroups seems to differ from the overall effect. A bit tired of misinterpretation of subgroup analyses.... https://t.co/XD8aABkmcW
M. Bolton
@5_utr
● NEUTRAL @SuyogCancer Look at prognosis headed out towards 20 months I am convinced many of these patients should be getting early palliative care
OncoHeb
@EoHeb
● NEUTRAL #ASCO24 @OncoAlert Docetaxel strikes again: NEGATIVE (maybe numerically positive) OS benefit on the ph3 EVOKE-01, sacituzumab govitecan NSCLCm post-IO, post-platinum, HR0.84 p=0.05 (CI over 1), median OS 11vs9m, median PFS 4vs3.9m.
Susan Roberts
@_SusanRoberts
● NEUTRAL @Latinamd Promising improvements with SG, especially in non-responsive patients, despite not meeting ITT OS significance. Crucial insights for #NSCLC treatment! #ASCO24
Stephen V Liu, MD
@StephenVLiu
● NEGATIVE EVOKE-01 from #ASCO24 @JCO_ASCO. Phase III study of the Trop2 ADC sacituzumab govitecan vs docetaxel in NSCLC post chemo/IO. Did not meet OS endpoint (11.1 vs 9.8m, HR 0.84) but numeric improvement in squamous &amp; non-sq. If nonresponsive to IO, OS
Oncology News Central
@OncNewsCentral
● NEGATIVE #ASCO24: EVOKE-01 - sacituzumab govitecan-hziy (Trodelvy) did not meet primary endpoint for OS in metastatic #NSCLC but shows potential benefits over docetaxel. Further ADC studies needed. https://t.co/C3EACb0Gyv via @lpazares [LBA8500]
Laura Book
@LauraJBook
● NEGATIVE @BenjaminBesseMD @dplanchard @EGFRResisters ADCs are being hyped but their ORRs aren’t very impressive and lots of toxicities. Let’s keep it real pls.
Ben Creelan, MD
@BenCreelan
● NEGATIVE @christine_lovly @OncoAlert The $21 billion acquisition of Immunomedics is not looking great now. ☹️ Hopefully they can turn it around somehow.
Ethan Lu
@VitalVentE
● NEGATIVE @JordiRemon EVOKE-01 shows the challenges ADCs face in NSCLC. Investing in better biomarkers is crucial. UAE's focused biotech support provides a stable ground for such research. #ASCO24