Abstract 8P
Background
Amivantamab (ami) is an EGFR-MET bispecific antibody with immune cell-directing activity. In MARIPOSA-2 (NCT04988295), ami plus carboplatin-pemetrexed (ami-chemo) significantly prolonged progression-free survival (PFS) vs chemo (HR, 0.48; P<0.001) in patients (pts) with EGFR-mutant advanced NSCLC after progression on osimertinib (Passaro Ann Oncol 2023). We evaluated time to symptomatic progression (TTSP) and patient-reported outcomes (PROs) from MARIPOSA-2.
Methods
Analyses included 131 pts randomized to ami-chemo and 263 pts to chemo (intent-to-treat population [ITT]) who died or discontinued treatment. TTSP was defined as time from randomization to onset of new/worsening lung cancer symptoms requiring change in anticancer therapy, another clinical intervention, or death, whichever occurred first. PROs were measured using EORTC-QLQ-C30, NSCLC-SAQ, and PROMIS-PF 8c instruments; P values were nominal.
Results
At a median follow-up of 8.7 mo, a trend towards improvement in TTSP was observed for ami-chemo vs chemo (median, 14.9 vs 13.0 mo; HR, 0.74 [95% CI, 0.51–1.07]; P=0.10). Median treatment duration was 6.3 mo for ami-chemo vs 3.7 mo for chemo. At 6 mo (189 days), the percentage of ITT pts who remained on treatment and had improved or stable physical functioning relative to baseline was 37% for ami-chemo vs 21% for chemo; P<0.01). There were higher percentages of pts with improved or stable emotional functioning (38% vs 21%; P<0.01), cognitive functioning (38% vs 20%; P<0.01), role functioning (30% vs 19%; P=0.2), and global health status (40% vs 19%; P<0.01) for ami-chemo vs chemo, respectively. Based on data from EORTC-QLQ-C30, at 6 mo 28% vs 13% pts reported no dyspnea (P<0.01), 23% vs 15% reported no pain (P<0.05), and 10% vs 5% reported no fatigue for ami-chemo vs chemo (P>0.05), respectively. Updated results will include data from the NSCLC-SAQ and PROMIS-PF 8c instruments.
Conclusions
Ami-chemo numerically prolonged TTSP vs chemo. More pts in the ITT population reported improved or stable functioning and absence of lung cancer-related symptoms for ami-chemo vs chemo in pts with EGFR-mutant advanced NSCLC after disease progression on osimertinib.
Clinical trial identification
NCT04988295.
Editorial acknowledgement
Medical writing assistance was provided by Lumanity Communications Inc.
Legal entity responsible for the study
Janssen Pharmaceuticals.
Funding
Janssen Pharmaceuticals.
Disclosure
P. Tomasini: Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, BMS, Lilly, Janssen, Amgen, Takeda; Financial Interests, Institutional, Invited Speaker: Roche, AstraZeneca, Janssen, Amgen, Lilly, Takeda. A. Blasco Cordellat: Financial Interests, Personal, Speaker’s Bureau: Roche Pharma, Clover, Sanofi, Janssen Cilag, Takeda, GSK; Financial Interests, Personal, Other, Travel: Roche, Bristol, Takeda. C. Dooms: Financial Interests, Personal, Advisory Board: Advisory Board for Janssen-JNJ. M. Mackean: Financial Interests, Personal, Other, Consulting Fees: Boehringer Ingelheim, Roche, Takeda, AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Bristol Myers Squibb, Takeda; Financial Interests, Personal, Other, Travel: Takeda, Bristol Myers Squibb, Janssen-Cilag, MSD, Roche. A. Bearz: Financial Interests, Personal, Advisory Board: Pfizer, Roche; Financial Interests, Personal, Invited Speaker: BMS, Pfizer, Eli Lilly, Janssen, Novartis; Non-Financial Interests, Personal, Principal Investigator: Roche, Pfizer, Gilead, MSD. O.J. Juan Vidal: Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Merck Sharp & Dohme, Lilly, Takeda, AstraZeneca, Janssen; Financial Interests, Personal, Invited Speaker: Roche/Genentech; Financial Interests, Institutional, Funding: AstraZeneca. D.M. Kowalski: Financial Interests, Personal, Other, Consulting Fees: Advisory Board: BMS, MSD, Pfizer, AstraZeneca, Novartis, Roche, Takeda, Boehringer-Ingelheim, Sanofi-Aventis, Amgen, Johnson & Johnson, Merck; Financial Interests, Personal, Leadership Role: Polish Lung Cancer Study Group. K. Stencel: Financial Interests, Personal, Other, provision of study materials, medical writing, article processing charges: Janssen; Financial Interests, Personal, Speaker’s Bureau: Amgen, AstraZeneca, BMS, MSD, Takeda, Roche, Janssen, Pfizer, Amgen; Financial Interests, Personal, Other, Travel: MSD, Roche; Financial Interests, Personal, Advisory Board:MSD, Amgen; Financial Interests, Personal, Writing Engagements: BMS. A. Zer: Financial Interests, Personal, Invited Speaker: Roche, BMS, MSD, Takeda, Pfizer, Novartis; Financial Interests, Personal, Advisory Board: AstraZeneca, Steba, Oncohost; Financial Interests, Personal, Other, Safety Review Committee Member: Beyond Air; Financial Interests, Personal, Stocks/Shares: Nixio; Financial Interests, Institutional, Research Grant: BMS. J. Schuchard, J. Diels, P. Chu, S. Shah, B. Diorio, A. Garvin, J.M. Bauml: Financial Interests, Personal, Full or part-time Employment: Janssen; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. E. Felip: Financial Interests, Personal, Advisory Board: AbbVie, Amgen, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, Gilead, GSK, Janssen, Merck Serono, Merck Sharp & Dohme, Novartis, Peptomyc, Regeneron, Sanofi, Takeda, Turning Point, Pfizer; Financial Interests, Personal, Invited Speaker: Amgen, Daiichi Sankyo, Genentech, Janssen, Medical Trends, Medscape, Merck Serono, PeerVoice, Pfizer, Sanofi, Takeda, Touch Oncology, AstraZeneca, Bristol Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, Merck Sharp & Dohme; Financial Interests, Personal, Member of Board of Directors, Independent member: Grifols; Financial Interests, Institutional, Invited Speaker, Clinical Trial: AstraZeneca AB, AbbVie, Amgen, Bayer Consumer Care AG, BeiGene, Boehringer Ingelheim GmbH, Bristol Myers Squibb International Corporation, Daiichi Sankyo Inc., Exelixis Inc., F. Hoffmann-La Roche Ltd., Genentech Inc., GSK Research and Development Limited, Janssen Cilag International NV, Merck Sharp & Dohme Corp, Merck KGAA, Mirati Therapeutics Inc, Novartis Pharmaceutica SA, Pfizer, Takeda Pharmaceuticals International; Non-Financial Interests, Personal, Leadership Role, President (2021-2023): SEOM (Sociedad Espanola de Oncologia Medica); Non-Financial Interests, Personal, Member, Member of Scientific Committee: ETOP (European Thoracic Oncology Platform); Non-Financial Interests, Personal, Member, Member of the Scientific Advisory Committee: CAC Hospital Universitari Parc Taulí. All other authors have declared no conflicts of interest.