1383P - Efficacy of capmatinib compared to standard of care for German patients with locally advanced or metastatic NSCLC harboring METex14 mutations: Results from the RECAP study

Background

Capmatinib, a selective MET inhibitor, is approved by EMA and other health authorities worldwide for the treatment of adult patients (pts) with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping (METex14) mutations. The RECAP study provided comparative evidence of capmatinib vs standard of care (SoC) in first (1L) and second line (2L) NSCLC pts with METex14 mutations (NCT05796726).

Methods

The RECAP study is a historical comparison of capmatinib pts from the GEOMETRY mono-1 study with an external control arm of SoC pts from German routine care collected via a retrospective chart review. Analyses were performed both naive and propensity score adjusted. Evaluated outcomes included efficacy endpoints such as overall survival (OS), progression-free survival (PFS), overall response rate (ORR), time to CNS progression (CNSprog) and exploratory safety endpoints.

Results

A total of 119 1L and 46 2L pts were included in the chart review and compared to 60 1L and 81 2L pts treated with capmatinib. For 1L pts, the naive comparison showed a significant benefit of capmatinib for OS (median 25.49 vs 14.59 months; HR 0.58; 95% CI 0.39-0.87; p=0.011), PFS (median 12.45 vs 5.03 months; HR 0.44; 95% CI 0.31-0.63; p<0.001) and ORR (event rate 68.3 vs 26.9%; RR 2.54; 95% CI 1.80-3.58; p<0.001). In 2L, OS, PFS and ORR showed trends favoring capmatinib with no significant results. Notably, CNSprog resulted in a significant benefit with capmatinib in 1L and 2L. No patient developed new, symptomatic brain metastases during capmatinib treatment. Propensity score adjusted analyses showed consistent results to naive analysis. Exploratory safety endpoints indicate a manageable safety profile for capmatinib.

Conclusions

For 1L pts, clinically relevant effects of capmatinib are seen in all efficacy and safety endpoints before and after adjustment. 2L results are consistently in favor of capmatinib but are limited by low patient numbers. Overall, RECAP demonstrates the important role of capmatinib for NSCLC pts harboring METex14 mutations with significant efficacy in preventing the development of brain metastases.

Clinical trial identification

NCT05796726, CINC280ADE01.

Editorial acknowledgement

Legal entity responsible for the study

Novartis Pharma GmbH.

Funding

Novartis Pharma GmbH.

Disclosure

M. Scheffler: Financial Interests, Personal, Invited Speaker: Amgen, Boehringer Ingelheim, Takeda, Pfizer, Roche, Sanofi-Aventis; Financial Interests, Personal, Advisory Board: Amgen, Boehringer Ingelheim, Roche, Novartis, Amgen, Takeda, Pfizer, Pfizer, Amgen, Takeda, Janssen, Amgen; Financial Interests, Personal, Writing Engagement: Amgen; Financial Interests, Institutional, Local PI: Dracen Pharmaceuticals; Financial Interests, Institutional, Coordinating PI: Amgen, Dracen, Siemens Healthineers; Financial Interests, Personal, Steering Committee Member: Boehringer Ingelheim; Non-Financial Interests, Advisory Role, Patient advocacy: zielgenau e. V., YesWeCan(cer); Non-Financial Interests, Principal Investigator, YouTube channel for patients: OncoEducation. M. Wiesweg: Financial Interests, Personal, Invited Speaker: Amgen, Roche, Takeda, GSK, AstraZeneca; Financial Interests, Personal, Advisory Board: GSK, Novartis, Pfizer, Roche, Janssen, Daiichi Sankyo; Financial Interests, Institutional, Local PI: Takeda; Financial Interests, Institutional, Funding: Bristol Myers Squibb. H. Hummel: Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Invited Speaker: Amgen, Bristol Myers Squibb; Financial Interests, Institutional, Coordinating PI: Amgen; Financial Interests, Institutional, Local PI: Amgen, Revolution Medicines, Boehringer Ingelheim, Bristol Myers Squibb, Merck, Novartis, AstraZeneca, Drachen, Daiichi Sankyo, AvenCell Europe GmbH, Celgene; Financial Interests, Personal, Steering Committee Member: Amgen; Non-Financial Interests, Principal Investigator: AIO-Studien-gGmbH, Lung Cancer Group Cologne. J. Kollmeier: Financial Interests, Institutional, Advisory Board: Boehringer Ingelheim, AstraZeneca, Pfizer, MSD, Roche Pharma AG, Lilly Deutschland, Merck Serono GmbH, Bristol Myers Squibb, Janssen-Cilag GmbH; Financial Interests, Institutional, Local PI: MSD Sharp & Dohme GmbH, Takeda, Roche Pharma AG, Novartis; Non-Financial Interests, Member: Deutsche Gesellschaft für Hämatologie und Onkologie, Deutsche Krebsgesellschaft. M. Joosten: Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca GmbH, Healthcare Germany GmbH. S. Merkelbach-Bruse: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, QuIP, Novartis; Financial Interests, Personal, Advisory Role: GSK, Qiagen. K. Oeser: Other, Personal, Full or part-time Employment: Novartis. M. Zehaczek, U. Jeratsch: Other, Personal, Full or part-time Employment: Novartis Pharma GmbH. J. Wolf: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Blueprint, BMS, Boehringer Ingelheim, Daiichi Sankyo, Ignyta, Janssen, Lilly, Loxo, MSD, Novartis, Pfizer, Roche, Seattle Genetics, Takeda; Financial Interests, Personal, Invited Speaker: Bayer, Chugai; Financial Interests, Institutional, Research Grant: BMS, Janssen, Novartis, Pfizer. All other authors have declared no conflicts of interest.