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

• Published in: International journal of clinical oncology 2022-04, Vol.27 (4), p.695-706
• Main Authors: John, Thomas, Sakai, Hiroshi, Ikeda, Satoshi, Cheng, Ying, Kasahara, Kazuo, Sato, Yuki, Nakahara, Yoshiro, Takeda, Masayuki, Kaneda, Hiroyasu, Zhang, Helong, Maemondo, Makoto, Minato, Koichi, Hisada, Takeshi, Misumi, Yuki, Satouchi, Miyako, Hotta, Katsuyuki, Li, Ang, Oukessou, Abderrahim, Lu, Shun
• Format: Article
• Language: English
• Subjects: Adolescent; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Cancer Research; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - pathology; Chemotherapy; Humans; Immunotherapy; Ipilimumab - adverse effects; Lung cancer; Lung Neoplasms - drug therapy; Lung Neoplasms - genetics; Medicine; Medicine & Public Health; Monoclonal antibodies; Neoplasm Recurrence, Local - drug therapy; Nivolumab - therapeutic use; Non-small cell lung carcinoma; Oncology; Original; Original Article; Patients; Small cell lung carcinoma; Surgical Oncology; Targeted cancer therapy
• ISSN: 1341-9625; 1437-7772
• DOI: 10.1007/s10147-022-02120-0

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.