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Title: 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.
Austin 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
Affiliation: Austin Health
Bristol Myers Squibb, 3551 Lawrenceville Road, Princeton, NJ, USA
Saitama Cancer Center, 780, Komuro, Ina, Kitaadachi District, Saitama, 362-0806, Japan
Kanagawa Cardiovascular and Respiratory Center, 6 Chome-16-1 Tomiokahigashi, Kanazawa Ward, Yokohama, Kanagawa, 236-0051, Japan
Jilin Cancer Hospital, No. 1018 Huguang Road, Changchun, 130012, China
Kanazawa University Hospital, 13-1 Takaramachi, Kanazawa, Ishikawa, 920-8641, Japan
Kobe City Medical Center General Hospital, 2-1-1, Minatojima Minamimachi, Chuo Ward, Kobe, Hyogo, 650-0047, Japan
Kanagawa Cancer Center, 2 Chome-3-2 Nakao, Asahi Ward, Yokohama, Kanagawa, 241-8515, Japan
Kindai University Hospital, 377-2 Onohigashi, Osakasayama, Osaka, 589-8511, Japan
Osaka City University Hospital, 1 Chome-5-7 Asahimachi, Abeno Ward, Osaka, 545-8586, Japan
Tangdu Hospital, Xinsi Road, Baqiao District, Xi'an, 710038, Shaanxi, China
Iwate Medical University Hospital, 2-1-1 Idaidori, Yahaba-cho, Shiwa District, Iwate, 028-3695, Japan
Gunma Prefectural Cancer Center, 617-1 Takahayashinishi-cho, Ota-shi, Gunma, 373-8550, Japan
Gunma University Hospital, 3 Chome-39-15 Showamachi, Maebashi, Gunma, 371-8511, Japan
Yokohama Municipal Citizen's Hospital, 1-1 Mitsuzawa Nishimachi, Kanagawa Ward, Yokohama, Kanagawa, 221-0855, Japan
Hyogo Cancer Center, 13-70 Kita-Oji, Akashi, Hyogo, 673-8558, Japan
Okayama University Hospital, 2 Chome-5-1 Shikatacho, Kita Ward, Okayama, 700-0914, Japan
Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, 241 West Huaihai Road, Shanghai, China
Issue Date: Apr-2022
Date: 2022-02-19
Publication information: International Journal of Clinical Oncology 2022; 27(4): 695-706
Abstract: 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. 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). 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. 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.
DOI: 10.1007/s10147-022-02120-0
ORCID: 0000-0003-3399-5342
Journal: International Journal of Clinical Oncology
PubMed URL: 35182247
PubMed URL:
Type: Journal Article
Subjects: Asia
Non-small cell lung cancer
Appears in Collections:Journal articles

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