7P Patient-relevant endpoints from PAPILLON: Amivantamab plus chemotherapy vs chemotherapy as first-line treatment of EGFR exon 20 insertion-mutated (Ex20ins) advanced NSCLC

Document Type

Presentation

Publication Date

3-2024

Publication Title

ESMO Open

Keywords

oregon; chiles

Abstract

Background

Amivantamab (ami) is an EGFR-MET bispecific antibody with immune cell-directing activity. In PAPILLON (NCT04538664), ami plus carboplatin-pemetrexed (ami-chemo) significantly prolonged progression-free survival (PFS) vs chemo (median, 11.4 vs 6.7 months [mo]; HR, 0.40; [95% CI, 0.30–0.53]; P<0.001; Zhou NEJM 2023). We evaluated time to symptomatic progression (TTSP) and patient-reported outcomes (PROs) from PAPILLON.

Methods

These analyses included 153 patients (pts) randomized to ami-chemo and 155 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 the EORTC-QLQ-C30 and PROMIS-PF 8c instruments; P values were nominal.

Results

At a median follow-up of 14.9 mo, median TTSP was significantly longer for ami-chemo vs chemo (NE vs 20.1 mo; HR, 0.67 [95% CI, 0.46–0.98]; P=0.04). Median treatment duration was 9.7 mo for ami-chemo and 6.7 mo for chemo. At 6 mo (189 days), the percentage of ITT pts with improved/stable physical functioning relative to baseline was 54% for ami-chemo vs 41% for chemo (P<0.02). There were higher percentages of pts with improved or stable emotional functioning (63% vs 47%; P=0.01), cognitive functioning (47% vs 38%), role functioning (50% vs 41%), and global health status (51% vs 42%) for ami-chemo vs chemo, respectively (P>0.05 for all). At 6 mo, 43% vs 25% of pts reported no dyspnea (P<0.01), 36% vs 31% reported no pain (P>0.05), and 18% vs 8% reported no fatigue for ami-chemo vs chemo (P<0.02), respectively. Updated results will include data from PROMIS-PF 8c.

Conclusions

Ami-chemo significantly prolonged time to symptomatic progression 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. The deeper tumor responses and improved disease control observed with ami-chemo corresponded with improved patient-relevant endpoints in first-line EGFR Ex20ins advanced NSCLC.

Clinical trial identification

NCT04538664.

Editorial acknowledgement

Medical writing assistance was provided by Lumanity Communications Inc and funded by Janssen Global Services LLC.

Legal entity responsible for the study

Janssen Pharmaceuticals.

Funding

Janssen Pharmaceuticals.

Disclosure

L. Paz-Ares: Financial Interests, Personal, Advisory Board, Speaker fees: Roche, MSD, BMS, AZ, Lilly, PharmaMar, BeiGene, Daiichi Sankyo, Medscape, PER; Financial Interests, Personal, Advisory Board: Merck Serono, Pfizer, Bayer, Amgen, Janssen, GSK, Novartis, Takeda, Sanofi, Mirati; Financial Interests, Personal, Other, Board member: Genomica, Altum sequencing; Financial Interests, Personal, Member of Board of Directors, Board member: Stab Therapeutics; Financial Interests, Institutional, Invited Speaker: Daiichi Sankyo, AstraZeneca, Merck Sharp & Dohme corp, BMS, Janssen-cilag international NV, Novartis, Roche, Sanofi, Tesaro, Alkermes, Lilly, Takeda, Pfizer, PharmaMar; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Other, Member: AACR, ASCO, ESMO; Financial Interests, Personal, Other, Foundation Board Member: AECC; Financial Interests, Personal, Other, President.ASEICA(Spanish Association of Cancer Research ): ASEICA; Financial Interests, Personal, Other, Foundation president: ONCOSUR; Financial Interests, Personal, Other, member: Small Lung Cancer Group. R. Veillon: Financial Interests, Institutional, Research Grant: AstraZeneca, AbbVie, Merck Serono, Bristol Myers Squibb, Sanofi, GSK, Novartis, Gilead, Roche, Janssen; Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, Bristol Myers Squibb, MSD, Pfizer, Takeda, Sanofi; Financial Interests, Personal, Other, Support for attending meetings and/or travel: Janssen, Takeda, Sanofi. M. Majem: Financial Interests, Personal, Advisory Board: Amgen, Roche, AstraZeneca, Takeda, Janssen, Cassen Recordati, BMS, Sanofi; Financial Interests, Personal, Invited Speaker: Amgen, Roche, AstraZeneca, Pfizer, Takeda, Helsinn; Financial Interests, Institutional, Funding: BMS, AstraZeneca, Roche; Non-Financial Interests, Personal, Leadership Role, Board Member: Associacio Contra El Cancer Barcelona. C. Zhou: Financial Interests, Personal, Invited Speaker, Honoraria: Eli Lilly, Roche, Sanofi, Qilu Pharma, Hengrui, Innovent Biologics, C-Stone, LUYE Pharma, TopAlliance Biosciences Inc; Financial Interests, Personal, Invited Speaker, BI: BI; Financial Interests, Personal, Invited Speaker, MSD:MSD; Financial Interests, Personal, Advisory Board, Advisor: Amoy Diagnositics. S. Kim: Financial Interests, Institutional, Other, Provision of study materials: Janssen. N. Girard: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, MSD, Roche, Pfizer, Mirati, Amgen, Novartis, Sanofi, Gilead; Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, MSD, Roche, Pfizer, Janssen, Boehringer, Novartis, Sanofi, AbbVie, Amgen, Lilly, Grunenthal, Takeda, Owkin, Leo Pharma, Daiichi Sankyo, Ipsen; Financial Interests, Institutional, Research Grant, Local: Roche, Sivan, Janssen; Financial Interests, Institutional, Funding: BMS, Leo Pharma; Financial Interests, Institutional, Research Grant: MSD; Other, Personal, Other, Family member is an employee: AstraZeneca. R.E. Sanborn: Financial Interests, Personal, Advisory Board: AstraZeneca, EMD Serono, Daiichi Sankyo, Lilly Oncology, Janssen Oncology, Macrogenics, Sanofi Aventis, Regeneron, Mirati Therapeutics, GSK, G1 Therapeutics; Financial Interests, Personal, Invited Speaker: Illumina, GSK, Janssen Oncology; Financial Interests, Institutional, Funding, Funding for investigator-sponsored trial: Merck, AstraZeneca; Financial Interests, Institutional, Other, Institutional research support: BMS; Financial Interests, Institutional, Funding, Clinical trial funding: Jounce. A.S. Mansfield: Financial Interests, Institutional, Research Grant: Novartis, Verily; Financial Interests, Institutional, Other, Consulting fees: Rising Tide – grant reviewer, TRIPTYCH Health Partners Expert Think Tank; Financial Interests, Institutional, Other, Steering committee: Janssen - steering committee, Johnson & Johnson Global Services – steering committee; Financial Interests, Institutional, Invited Speaker: BeiGene, Chugai Pharmaceutical Co Ltd (Roche), Immunocore - presentation; Financial Interests, Institutional, Invited Speaker, Moderator: Ideology Health LLC (formerly Nexus Health Media) - moderator; Financial Interests, Personal, Invited Speaker, CME presentation: Antoni van Leeuwenhoek Kanker Instituut – CME presentation; Financial Interests, Institutional, Invited Speaker, CME presentation: AXIS Medical Education, Inc. – CME presentation, Intellisphere LLC (OncLive Summit Series) – CME presentation, Answers in CME – CME presentation; Financial Interests, Personal, Invited Speaker: University of Miami Int’l Mesothelioma Symposium – speaker; Financial Interests, Personal, Other, Travel: Shanghai Roche; Financial Interests, Institutional, Advisory Board: AbbVie, AstraZeneca, Bristol Myers Squibb, Genentech/Roche, Takeda Oncology; Non-Financial Interests, Personal, Leadership Role, Non-remunerated Director: Mesothelioma Applied Research Foundation, Friends of Patan Hospital; Financial Interests, Personal, Other, Study funding, article processing charges: Bristol Myers Squibb. K. Park: Financial Interests, Personal, Advisory Board: JNJ, AstraZeneca, Daiichi Sankyo, Eli Lilly, Samsung Medical Center; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Other, DMC member: BeiGene, Incyte; Financial Interests, Personal, Other, Advisor/Consultant: Genius, IMBdx; Financial Interests, Personal, Other, Advisor: ABION; Financial Interests, Personal, Stocks/Shares, Stock option: IMBDx, GENIUS. J. Sermon, J. Schuchard, A. Bhattacharya, P. Lorenzini, M. Baig,T. Agrawal, R.E. Knoblauch: Financial Interests, Personal, Full or part-time Employment: Janssen; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. A. Ono: Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Invited Speaker: Janssen Research & Development. J. Sabari: Financial Interests, Personal, Advisory Board: AstraZeneca, Genentech, Janssen, Pfizer, Regeneron, Sanofi Genzyme, Takeda, Mirati Therapeutics. All other authors have declared no conflicts of interest.

Clinical Institute

Cancer

Department

Oncology

Department

Pharmacy


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