First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in advanced non-small cell lung cancer: a subanalysis of Asian patients in CheckMate 9LA

Thomas John, Hiroshi Sakai, Satoshi Ikeda, Ying Cheng, Kazuo Kasahara, Yuki Sato, Yoshiro Nakahara, Masayuki Takeda, Hiroyasu Kaneda, Helong Zhang, Makoto Maemondo, Koichi Minato, Takeshi Hisada, Yuki Misumi, Miyako Satouchi, Katsuyuki Hotta, Ang Li, Abderrahim Oukessou, Shun Lu

Research output: Contribution to journalArticlepeer-review

Abstract

Background: CheckMate 9LA, a phase 3, randomized, open-label study in first-line advanced non-small cell lung cancer (NSCLC), showed significantly improved overall survival (OS) with nivolumab plus ipilimumab combined with 2 cycles of chemotherapy versus chemotherapy alone (4 cycles). We present results for the Asian subpopulation enrolled in Japan and China. Methods: Patients aged ≥ 18 years with treatment-naive, histologically confirmed stage IV or recurrent NSCLC, Eastern Cooperative Oncology Group performance status 0–1 and no sensitizing EGFR/ALK mutations were randomized 1:1 to nivolumab [360 mg every 3 weeks (Q3W)] plus ipilimumab (1 mg/kg Q6W) combined with chemotherapy (Q3W for 2 cycles), or chemotherapy alone (Q3W for 4 cycles). Primary endpoint was OS; secondary endpoints included progression-free survival (PFS) and objective response rate (ORR). Results: Twenty-eight patients received nivolumab plus ipilimumab combined with chemotherapy and 30 received chemotherapy. At a minimum follow-up of 12.7 months, median OS was not reached with nivolumab plus ipilimumab combined with chemotherapy versus 13.3 months with chemotherapy [hazard ratio (HR) 0.33; 95% confidence interval (CI) 0.14–0.80]. Median PFS was 8.4 versus 5.4 months (HR 0.47; 95% CI 0.24–0.92) and ORR was 57% versus 23%, respectively. Grade 3–4 treatment-related adverse events were observed in 57% versus 60% of patients, respectively. Conclusion: Consistent with results in the all randomized population, nivolumab plus ipilimumab combined with chemotherapy improved efficacy in the Asian subpopulation versus chemotherapy alone and had a manageable safety profile, supporting its use as first-line treatment for advanced NSCLC in Asian patients.

Original languageEnglish
Pages (from-to)695-706
Number of pages12
JournalInternational Journal of Clinical Oncology
Volume27
Issue number4
DOIs
Publication statusPublished - Apr 2022
Externally publishedYes

Keywords

  • Asia
  • Immunotherapy
  • Ipilimumab
  • Japan
  • Nivolumab
  • Non-small cell lung cancer

ASJC Scopus subject areas

  • Surgery
  • Hematology
  • Oncology

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