Background

Amivantamab, a bispecific EGFR and MET antibody, demonstrated efficacy and safety in patients (pts) with advanced NSCLC with EGFR exon20ins in CHRYSALIS (NCT02609776), a phase I/II single-arm study. In the absence of a randomised controlled trial, adjusted comparisons vs a RW cohort, using data from medical records of similar pts, can provide comparative evidence for amivantamab vs RW SoC.

Methods

CATERPILLAR-RWE is a retrospective, non-interventional pan-European study to identify pts with advanced exon20ins NSCLC with ≥1 line of therapy (LOT) after prior platinum-based therapy, using pt medical records from 21 hospitals in 7 European countries. Overall response rate (ORR; investigator [INV] and independent review committee assessed [IRC]), overall survival (OS), progression-free survival (PFS; INV and IRC) and time-to-next treatment (TTNT) for amivantamab in CHRYSALIS were compared to SoC from CATERPILLAR-RWE. All eligible treatment lines from SoC pts were used. Binary and time to event endpoints were analysed using logistic regression and proportional hazards regression, respectively. Differences in pt and disease characteristics were adjusted for using inverse probability weighting and covariate adjustment.

Results

114 pts from CHRYSALIS were compared to 55 LOTs (38 pts; observed Eastern Cooperative Oncology Group performance status scores of 0 or 1) from CATERPILLAR-RWE. Following adjustment, amivantamab was significantly superior to European RW SoC across endpoints and methods (Table). INV and IRC results were consistent. Table: 1117P

Amivantamab vs SoC efficacy outcomes. ATT: average treatment effect on the treated; CI: confidence interval; HR: hazard ratio; OR: odds ratio.

Conclusions

Adjusted comparisons demonstrate significant improvements for amivantamab vs European RW SoC, as previously reported versus a US RWE cohort, highlighting the potential for amivantamab to address unmet medical need in pts with advanced exon20ins NSCLC.

Clinical trial identification

NCT02609776.

Editorial acknowledgement

Medical writing and editorial assistance for this abstract was provided by Rebecca van Pelt, MSc, Luke Green, PhD, and Molly Atkinson, BA, Costello Medical, UK, and funded by Janssen Pharmaceutica NV.

Legal entity responsible for the study

Janssen Pharmaceutica NV.

Funding

Janssen Pharmaceutica NV.

Disclosure

N. Girard: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, MSD, Roche, Pfizer, Mirati, Amgen, Novartis, Sanofi; Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, MSD, Roche, Pfizer, Janssen, Boehringer, Novartis, Sanofi, AbbVie, Amgen, Lilly, Grunenthal, Takeda, Owkin; Financial Interests, Institutional, Research Grant, Local: Roche, Sivan, Janssen; Financial Interests, Institutional, Funding: BMS; Non-Financial Interests, Officer, International Thymic malignancy interest group, president: ITMIG; Other, Family member is an employee: AstraZeneca. S. Popat: Financial Interests, Personal, Advisory Board: Boehringer Ingelheim, Novartis, Amgen, Janssen, Daiichi Sankyo, AstraZeneca, Bayer, BMS, Blueprint, Merck Serono, Guardant Health, BeiGene, Takeda, Lilly, Seattle Genetics, Turning Point Therapeutics, Xcovery, GlaxoSmithKline, MSD, Pfizer, Sanofi; Financial Interests, Personal, Expert Testimony: Roche; Financial Interests, Personal, Invited Speaker: Medscape, VJ Oncology, Touch Medical; Financial Interests, Personal, Other, Journal Deputy Editor, Lung Cancer: Elsevier; Financial Interests, Institutional, Other, Sub-investigator: Amgen; Financial Interests, Institutional, Invited Speaker: Ariad, AstraZeneca, Roche, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Trizel, GlaxoSmithKline, Takeda, Turning Point Therapeutics, Roche, Janssen, BMS, Lilly; Financial Interests, Institutional, Other, Sub-Investigator: MSD, Blueprint, Seattle Genetics; Financial Interests, Institutional, Research Grant: Guardant Health; Non-Financial Interests, Leadership Role, Foundation Council Member, Unpaid: European Thoracic Oncology Platform; Non-Financial Interests, Leadership Role, Chair of Steering Committee, Unpaid: British Thoracic Oncology Group; Non-Financial Interests, Officer, Thoracic Faculty, Unpaid: European Society of Medical Oncology; Non-Financial Interests, Advisory Role, Mesothelioma Task-force Member, Unpaid: International Association for the Study of Lung Cancer; Non-Financial Interests, Invited Speaker, Unpaid: Mesothelioma Applied Research Foundation; Non-Financial Interests, Advisory Role, Honorary Clinical Advisor, Unpaid: ALK Positive UK; Non-Financial Interests, Advisory Role, Research Advisory Group Member, Unpaid: Ruth Strauss Foundation; Non-Financial Interests, Advisory Role, Scientific Adivsory Board Member, Unpaid: Lung Cancer Europe. N. Rahhali: Financial Interests, Personal, Full or part-time Employment, I am a full-time employee of Janssen-Cilag - Johnson & Johnson: Janssen Cilag; Financial Interests, Personal, Stocks/Shares, I am a Janssen-Cilag full-time employee: Janssen Cilag. B. Rodrigues, C.A. Schioppa, A. Adamczyk, J. Sermon, J. Penton: Financial Interests, Personal, Full or part-time Employment: Janssen; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. C. Pick-Lauer: Financial Interests, Personal, Full or part-time Employment: Janssen. J. Diels: Financial Interests, Personal, Full or part-time Employment, Employee Janssen EMEA Head of Market Access Analytics and modelling: Janssen; Financial Interests, Personal, Stocks/Shares, Holds JNJ shares: Janssen. M. Thomas: Financial Interests, Personal, Advisory Board: Sanofi, Lilly, BMS, MSD, Roche, Boehringer, Janssen, AstraZeneca, Amgen, Novartis; Financial Interests, Personal, Invited Speaker: Sanofi, Lilly, MSD, Roche, GSK, Pfizer, Janssen, AstraZeneca, Amgen, Novartis; Financial Interests, Institutional, Advisory Board: Takeda; Financial Interests, Institutional, Invited Speaker: Takeda; Financial Interests, Institutional, Funding: Roche, Takeda, BMS, AstraZeneca, Amgen.