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

被引:1
作者
Kim, Tae Min [1 ]
Girard, Nicolas [2 ]
Low, Grace Kah Mun [3 ]
Zhuo, Jianmin [4 ]
Yu, Dae Young [5 ]
Yang, Yishen [4 ]
Murota, Maiko [6 ]
Lim, Cindy Thiow Koon [7 ]
Kleinman, Nora J. [8 ]
Cho, Byoung Chul [9 ]
机构
[1] Seoul Natl Univ Hosp, Dept Internal Med, Seoul, South Korea
[2] Inst Curie, Inst Thorax Curie Montsouris, Paris, France
[3] Johnson & Johnson Int Singapore Pte Ltd, Med Affairs, Janssen Asia Pacif Med Affairs, Singapore, Singapore
[4] Janssen China Res & Dev, Stat & Decis Sci, Beijing, Peoples R China
[5] Janssen Asia Pacific, Real World Evidence, Seoul, South Korea
[6] Janssen Res & Dev, Global Dev, Med Affair Operat, Tokyo, Japan
[7] IQVIA Solut Asia Pte Ltd, Real World Solut, Singapore, Singapore
[8] IQVIA Hong Kong, Real World Solut, Kwai Fong, Hong Kong, Peoples R China
[9] Yonsei Univ, Dept Med Oncol, Yonsei Canc Ctr, Coll Med, Seoul, South Korea
关键词
CHRYSALIS trial; external control; LC-SCRUM-Asia; amivantamab; EGFR exon 20 insertions; MOLECULAR HETEROGENEITY; CLINICAL-RESPONSE; ADENOCARCINOMAS;
D O I
10.1080/0284186X.2023.2254479
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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 14.09months, HR [95% CI] 0.59 [0.40-0.88]), PFS (median PFS 6.74 vs 4.73months, HR 0.59 [0.45-0.78]), TTNT (median TTNT 12.16 vs 5.09months, 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.
引用
收藏
页码:1689 / 1697
页数:9
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