Amivantamab compared with real-world therapies in patients with advanced non-small cell lung cancer EGFR Exon 20 insertion mutations after platinum-based chemotherapy

Authors

  • Tae Min Kim a Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea
  • Nicolas Girard b Institut Curie, Institute du Thorax Curie-Montsouris, Paris, France
  • Grace Kah Mun Low c Medical Affairs, Janssen Asia Pacific Medical Affairs, a division of Johnson & Johnson International (Singapore) Pte. Ltd
  • Jianmin Zhuo d Statistics and Decision Science, Janssen China Research & Development, China
  • Dae Young Yu e Real World Evidence, Janssen Asia Pacific, Republic of Korea
  • Yishen Yang d Statistics and Decision Science, Janssen China Research & Development, China
  • Maiko Murota f Global Development, Medical Affair Operations, Janssen Research & Development, Tokyo, Japan
  • Cindy Thiow Koon Lim g Real World Solutions, IQVIA Solutions Asia Pte Ltd, Singapore
  • Nora J. Kleinman h Real World Solutions, IQVIA Hong Kong, Kwai Fong, Hong Kong, P.R. China
  • Byoung Chul Cho i Department of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea

DOI:

https://doi.org/10.1080/0284186X.2023.2254479

Keywords:

CHRYSALIS trial, external control, LC-SCRUM-Asia, amivantamab, EGFR exon 20 insertions

Abstract

Background

In the single-arm CHRYSALIS trial, advanced non-small cell lung cancer patients harboring epidermal growth factor receptor (EGFR) exon 20 insertion (Exon 20ins) showed durable responses to amivantamab, an EGFR-MET bispecific antibody targeting tumors with EGFR Exon 20ins. This study compared the effectiveness of amivantamab to real-world systemic anti-cancer therapies in Japan.

Patients and methods

External control patients were selected by applying CHRYSALIS eligibility to Japanese patients from LC-SCRUM-Asia. External control patients were included for every qualifying line of therapy after platinum-based chemotherapy. Propensity score weighting was applied to external control patients to adjust for differences in baseline characteristics. Outcomes were compared between external control patients, and all and Asian-only CHRYSALIS patients using weighted Cox proportional hazards regression models for progression-free survival (PFS), time to next therapy (TTNT), and overall survival (OS), and generalized estimating equations with repeated measurements for overall response rate (ORR).

Results

One hundred fifteen CHRYSALIS and 94 external control patients were identified. Compared to external control patients, amivantamab-treated patients had significantly longer OS (median OS 19.88 vs 14.09 months, HR [95% CI] 0.59 [0.40–0.88]), PFS (median PFS 6.74 vs 4.73 months, HR 0.59 [0.45–0.78]), TTNT (median TTNT 12.16 vs 5.09 months, HR 0.39 [0.29–0.53]), and significantly higher ORR (41.7% vs 14.1%). Analyses of amivantamab-treated Asian patients (n = 61) showed similar clinical benefits.

Conclusion

In the absence of clinical evidence from randomized clinical trials, this study reflects the benefit of amivantamab after platinum-based chemotherapy for advanced non-small cell lung cancer patients harboring EGFR Exon 20ins, compared to current real-world therapies.

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Published

2023-12-02

How to Cite

Min Kim, T., Girard, N., Mun Low, G. K., Zhuo, J., Young Yu, D., Yang, Y., … Chul Cho, B. (2023). Amivantamab compared with real-world therapies in patients with advanced non-small cell lung cancer EGFR Exon 20 insertion mutations after platinum-based chemotherapy. Acta Oncologica, 62(12), 1689–1697. https://doi.org/10.1080/0284186X.2023.2254479