Abstract 1115P
Background
In the single-arm CHRYSALIS study, amivantamab, an EGFR-MET bispecific antibody, showed durable responses in EGFR E20i aNSCLC patients (pts). We conducted an indirect treatment comparison study to evaluate the efficacy of amivantamab compared to current systemic anti-cancer therapies. Here we also explore amivantamab versus docetaxel (DOC), EGFR tyrosine kinase inhibitors (TKIs) or immuno-oncology (IO) in RW practice in Japan using a lung cancer genomic screening platform (LC-SCRUM-Asia) with more than 16,000 NSCLC pts from 2013.
Methods
External control (EC) pts were selected from LC-SCRUM-Asia by applying CHRYSALIS eligibility. First-time use of DOC, TKIs or IO after platinum-based chemotherapy in EC pts was compared to amivantamab in CHRYSALIS. Weighted Cox proportional hazards regression models were used to compare progression-free survival (PFS) and overall survival (OS). The Cochran Mantel-Haenszel Chi-Square test was used for overall response rate (ORR).
Results
8,322 NSCLC pts were enrolled and analyzed by targeted next-generation sequencing in LC-SCRUM-Asia between March 2015 and September 2020. EGFR E20i was detected in 148 pts (2%). The most common EGFR E20i subtype was A767_V769dupASV (28%), followed by S768_D770dupSVD (14%). Of the 148 EGFR E20i pts, 94 pts were selected as EC pts. Compared to DOC in EC pts (n=67), amivantamab-treated pts (n=115) had risk reduction in PFS (HR: 0.81 [95%CI: 0.57-1.16]; median: 6.7 vs 6.2 months) and OS (HR: 0.67 [0.43-1.04], 19.9 vs 16.6 months), and higher ORR (41.7% vs 26.0%, p=0.012). Compared to TKIs in EC pts (n=45), amivantamab-treated pts had risk reduction in PFS (HR: 0.39 [0.26-0.59], 6.7 vs 2.8 months) and OS (HR: 0.43 [0.26-0.71], 19.9 vs 10.4 months), and higher ORR (41.7% vs 11.5%, p<0.001). Compared to IO in EC pts (n=59), amivantamab-treated pts had risk reduction in PFS (HR: 0.44 [0.30-0.66], 6.7 vs 3.5 months) and OS (HR: 0.63 [0.41-0.99], 19.9 vs 14.6 months), and higher ORR (41.7% vs 8.3%, p<0.001).
Conclusions
Amivantamab-treated pts had better clinical benefits compared to DOC, TKIs and IO. Amivantamab should be considered a standard therapy after platinum-based chemotherapy for EGFR E20i aNSCLC pts.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Janssen Asia Pacific.
Funding
Janssen Asia Pacific.
Disclosure
H. Udagawa: Financial Interests, Institutional, Research Grant: Takeda. S. Matsumoto: Financial Interests, Personal, Invited Speaker: Merck Biopharma, Eli Lilly, AstraZeneca, Chugai, Nvartis; Financial Interests, Institutional, Invited Speaker: Merck Biopharma, Janssen Pharmaceutical K.K. T. Kato: Financial Interests, Personal, Advisory Board, speaker, consultancy: AstraZeneca, Eli Lilly, Merck Biopharma, MSD; Financial Interests, Personal, Advisory Board, speaker: Pfizer; Financial Interests, Personal, Other, consultancy: Daiichi Sankyo, Takeda, Taiho; Financial Interests, Personal, Other, consultancy, speaker: Chugai; Financial Interests, Personal, Invited Speaker: Ono, Novartis; Financial Interests, Personal, Advisory Board: BeiGene, Glaxo; Financial Interests, Personal, Full or part-time Employment, Family member: Eli Lilly; Financial Interests, Institutional, Invited Speaker: Chugai, MSD, Pfizer, AstraZeneca, Eli Lilly, AbbVie, Regeneron, Novartis, Amgen, Merck Biophama, Haihe Biopharma, Blueprint Medicines, Turning Point. R. Toyozawa: Financial Interests, Personal, Other, Honoraria: Chugai Pharmaceutical, Eli Lilly Japan, Taiho Pharmaceutical, Nippon Boehringer Ingelheim, Novartis Pharma, Ono Pharmaceutical; Financial Interests, Personal, Other, honoraria: AstraZeneca, Takeda Pharmaceutical, MSD, Pfizer Japan; Financial Interests, Institutional, Invited Speaker: AbbVie, Amgen, Takeda Pharmaceutical, Pfizer Japan, Daiichi Sankyo, Eli Lilly Japan, Novartis Pharma. K. Ohashi: Financial Interests, Personal, Invited Speaker: Lilly, Novartis Japan, Boehringer Ingelheim; Financial Interests, Personal, Research Grant: Boehringer Ingelheim, Chugai; Financial Interests, Personal, Funding: Lilly, Daiichi Sankyo, AstraZeneca. G. Low Massin: Financial Interests, Institutional, Stocks/Shares: Janssen Asia Pacific; Non-Financial Interests, Institutional, Full or part-time Employment: Janssen Asia Pacific. J. Zhuo: Non-Financial Interests, Institutional, Full or part-time Employment: Janssen China. D.Y. Yu: Non-Financial Interests, Institutional, Full or part-time Employment: Janssen Asia Pacific. Y. Yang: Non-Financial Interests, Institutional, Full or part-time Employment: Janssen China. K. Goto: Financial Interests, Personal, Invited Speaker: Amgen Inc., Amgen K.K., Amoy Diagnostics Co., Ltd., AstraZeneca K.K., Bayer U.S., Boehringer Ingelheim Japan, Inc., Bristol-Myers Squibb K.K., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., Guardant Health Inc., Merck Biopharma Co., Ltd., Novartis Pharma K.K., Ono Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Thermo Fisher Scientific K.K.; Financial Interests, Personal, Advisory Board: Janssen Pharmaceutical K.K.; Financial Interests, Personal, Expert Testimony: Medpace Japan K.K.; Financial Interests, Personal and Institutional, Funding: Amgen Inc., Amgen K.K., AstraZeneca K.K., Boehringer Ingelheim Japan, Inc., Bristol-Myers Squibb K.K., Chugai Pharmaceutical Co., Ltd., DAIICHI SANKYO Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., Haihe Biopharma Co., Ltd., Ignyta,Inc., Janssen Pharmaceutical K.K., Kissei Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Loxo Oncology, Inc., Medical & Biological Laboratories Co., Ltd., Merck Biopharma Co., Ltd., Merus N.V., MSD K.K., Ono Pharmaceutical Co., Ltd., Pfizer Japan Inc., Sumitomo Dainippon Pharma Co., Ltd., Spectrum Pharmaceuticals, Inc., Sysmex Corporation., Taiho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Turning Point Therapeutics,Inc.; Non-Financial Interests, Member: American Society of Clinical Oncology, The Japan Lung Cancer Society, Japanese Society of Medical Oncology, The Japanese Cancer Association. All other authors have declared no conflicts of interest.