Abstract 35P
Background
Amivantamab, an epidermal growth factor receptor (EGFR)-MET bispecific antibody, is approved for the treatment of patients with advanced EGFR ex20ins NSCLC that progressed on or after platinum-based chemotherapy. We present initial real-world experience with amivantamab acquired through the global PAA program.
Methods
Patients who were eligible for PAA (NCT04599712) had EGFR ex20ins NSCLC that progressed after platinum-based chemotherapy. Amivantamab (1050 mg; 1400 mg for bodyweight ≥80 kg) was administered intravenously once weekly for the first 4-week cycle, then every 2 weeks thereafter. Investigator assessment of response, based on radiologic and clinical judgement, was provided at the time of drug re-supply and was optional.
Results
As of 29 Oct 2021, 218 patients had received treatment with amivantamab across 120 sites in 19 countries; 66% from Asia, 22% from Europe, 8% from North America, and 5% from South America. The median age was 62 years (range, 24–84), and the median number of prior lines was 2 (range, 1–9), with 63% of patients heavily-pretreated with ≥2 prior lines. At the time of data cutoff (median follow-up of 4 months), 139 patients (64%) remain on treatment. The safety profile was consistent with previously-reported safety at the recommended dose (Park K, JCO 2021;39:3391); no new safety signals were identified. Among 82 patients with response information available, 25 (30%) reported partial responses. Frequency and response by site of exon 20 insertion will be reported at the time of the meeting. Median time to treatment discontinuation (events include patients who did not request drug within 45 days from last supply; patients who transitioned to commercial amivantamab were treated as censored) was 5.2 months (95% CI, 4.2–not evaluable).
Conclusions
The real-world experience of amivantamab from the PAA program was consistent with that observed from the registrational clinical trial (NCT02609776). At the time of data cutoff, 64% of patients remain on treatment. Patients who entered the amivantamab PAA program were heavily-pretreated, underscoring the high unmet need for patients with EGFR ex20ins NSCLC.
Clinical trial identification
NCT04599712.
Editorial acknowledgement
Medical writing assistance was funded by Janssen Global Services, LLC. and provided by Tracy T. Cao, PhD (JanssenGlobal Services, LLC).
Legal entity responsible for the study
Janssen R&D.
Funding
Janssen R&D.
Disclosure
T.M. Kim: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Hanmi; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: Novarits; Financial Interests, Personal, Invited Speaker: Roche/Genentech; Financial Interests, Personal, Advisory Board: Takeda; Financial Interests, Personal, Research Grant: AstraZeneca-KHIDI; Non-Financial Interests, Personal, Principal Investigator: AstraZeneca/MedImmune; Non-Financial Interests, Personal, Principal Investigator: Bayer; Non-Financial Interests, Personal, Principal Investigator: Boehringer-Ingelheim; Non-Financial Interests, Personal, Principal Investigator: Boryung; Non-Financial Interests, Personal, Principal Investigator: Genmab; Non-Financial Interests, Personal, Principal Investigator: Hanmi; Non-Financial Interests, Personal, Principal Investigator: Janssen; Non-Financial Interests, Personal, Principal Investigator: Merck Sereno; Non-Financial Interests, Personal, Principal Investigator: MSD Corp; Non-Financial Interests, Personal, Principal Investigator: Novartis; Non-Financial Interests, Personal, Principal Investigator: Regeneron; Non-Financial Interests, Personal, Principal Investigator: Roche/Genentech; Non-Financial Interests, Personal, Principal Investigator: Sanofi; Non-Financial Interests, Personal, Principal Investigator: Takeda. S. Lee: Financial Interests, Personal, Research Grant: MSD; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role, Honoraria: AstraZeneca. G. Chang: Non-Financial Interests, Personal, Invited Speaker: F. Hoffmann–La Roche, Ltd, Eli Lilly and Company Oncology, AstraZeneca, Pfizer, Boehringer Ingelheim, Bristol Myers Squibb, Merck Sharpe & Dohme. J. Shih: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: Eli Lilly; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Invited Speaker: Chugai Pharma; Financial Interests, Personal, Advisory Board: Takeda; Financial Interests, Personal, Advisory Board: CStone Pharmaceuticals; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb; Financial Interests, Personal, Invited Speaker: Ono Pharmaceuticals; Financial Interests, Personal, Research Grant: Roche. M.J. Hochmair: Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Advisory Board: AstraZeneca. J.K. Sabari: Financial Interests, Personal, Advisory Role: AstraZeneca, Janssen, Navire, Pfizer, Regeneron, Medscape, Takeda. A.I. Spira: Financial Interests, Institutional, Leadership Role: Next Oncology Virginia; Financial Interests, Personal, Stocks/Shares: Eli Lilly; Financial Interests, Personal, Other, Honoraria: CytomX Therapeutics, AstraZeneca/MedImmune, Merck, Takeda, Amgen, Janssen, Novarits, Bristol Myers Squibb, Bayer; Financial Interests, Personal, Advisory Role: Incyte, Amgen, Novartis, Mirati Therapeutics, Gritstone Oncology, Jazz Pharmaceuticals, Takeda, Janssen; Financial Interests, Institutional, Advisory Role: Array BioPharma, AstraZeneca/MedImmune, Merck, Bristol Myers Squibb; Financial Interests, Personal, Research Grant: LAM Therapeutics; Financial Interests, Institutional, Research Grant: Roche, AstraZeneca, Boehringer Ingelheim, Astellas Pharma, MedImmune, Novartis, Newlink Genetics, Incyte, AbbVie, Ignyta, LAM Therapeutics, Trovagene, Takeda, Macrogenics, CytomX Therapeutics, Astex Pharmaceuticals, Bristol Myers Squibb, Loxo, Arch Therap. C.A. Schioppa: Financial Interests, Personal, Full or part-time Employment: Johnson & Johnson; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. J.B. Rose: Financial Interests, Personal, Full or part-time Employment: Johnson & Johnson; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. M. Chioda: Financial Interests, Personal, Full or part-time Employment: Johnson & Johnson; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. A. Panaccione: Financial Interests, Personal, Full or part-time Employment: Johnson & Johnson; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. P. Mahadevia: Financial Interests, Personal, Full or part-time Employment: Johnson & Johnson; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. B.C. Cho: Financial Interests, Personal, Research Grant: Novartis, Bayer, AstraZeneca, MOGAM Institute, Dong-A ST, Champions Oncology, Janssen, Yuhan, Ono, Dizal Pharma, MSD, AbbVie, Medpacto, GIInnovation, Eli Lilly, Blueprint medicines, Interpark Bio Convergence Corp.; Financial Interests, Personal, Advisory Role: Novartis, AstraZeneca, Boehringer-Ingelheim, Roche, Bristol Myers Squibb, Ono, Yuhan, Pfizer, Eli Lilly, Janssen, Takeda, MSD, Janssen, Medpacto, Blueprint medicines; Financial Interests, Personal, Stocks/Shares: TheraCanVac Inc, Gencurix Inc, Bridgebio therapeutics, KANAPH Therapeutic Inc, Cyrus therapeutics, Interpark Bio Convergence Corp.; Financial Interests, Personal, Advisory Board: KANAPH Therapeutic Inc, Brigebio therapeutics, Cyrus therapeutics, Guardant Health, Joseah BIO; Financial Interests, Personal, Member of the Board of Directors: Gencurix Inc, Interpark Bio Convergence Corp.; Financial Interests, Personal, Royalties: Champions Oncology; Financial Interests, Personal, Ownership Interest: DAAN Biotherapeutics.