Ltd., Merck KGaA, MSD K.K., Ono Pharmaceutical Co. HS: research funding and/or honoraria: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Bristol Myers Squibb Japan, Chugai Pharmaceutical Co. Ltd., Daichi Sankyo, Janssen, Lilly, Merck, MSD, Nippon Kayaku, Novartis, Ono Pharmaceutical Co. MN: consulting/advisory and/or honoraria and/or research funding: Abbvie, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai Pharmaceutical Co. KP: advisor/consultant: Bristol Myers Squibb. KHL: advisory board: AstraZeneca, Bristol Myers Squibb, Eli Lilly, MSD, and Pfizer. Disclosure KJO: advisory board and/or speaker bureau and/or meeting travel/registration support from Astellas, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Janssen-Cilag, Merck Sharp & Dohme (MSD), Mundipharma, Natera, Novartis, Pfizer, Roche-Genentech, Teva, and TriStar board member and shareholder: Carpe Vitae Pharmaceuticals shareholder: DGC Diagnostics and RepLuca Pharmaceuticals holds patents for novel therapeutics and diagnostic tests. Authors received no financial support or compensation for publication of this manuscript. All authors had full access to all the data in the study. The funder contributed to data collection with the investigators, to data analysis and interpretation in collaboration with the authors, and to the writing of the report by funding professional medical writing assistance. Role of the funder The study was designed by the steering committee and the funder. Consistent with findings for all randomized patients, these data support the use of nivolumab plus ipilimumab as first-line treatment of Asian patients with advanced NSCLC.Īsia Japan ipilimumab nivolumab non-small cell lung cancer.Ĭopyright © 2022 The Authors. Grade 3-4 treatment-related adverse events occurred in 40% of patients receiving nivolumab plus ipilimumab and 36% receiving chemotherapy, in the overall Asian subpopulation (tumor PD-L1 expression ≥1% and <1%) no new safety signals were identified.Īt 3-year follow-up, nivolumab plus ipilimumab provided durable long-term efficacy benefits versus chemotherapy regardless of tumor PD-L1 expression in the Asian subpopulation, including Japanese patients. Similar results were observed regardless of tumor PD-L1 expression and in Japanese patients. The 3-year progression-free survival rate was 26% versus 7% (HR, 0.65 95% CI 0.45-0.96), objective response rate was 56% versus 37%, and median duration of response was 29.0 months (95% CI 15.0 months-not reached) versus 6.9 months (95% CI 3.9-11.1 months). Median OS was not reached with nivolumab plus ipilimumab versus 24.8 months with chemotherapy 3-year OS rate was 53% versus 37%. In the Asian subpopulation with PD-L1 ≥1%, 81 patients received nivolumab plus ipilimumab and 81 received chemotherapy. Overall survival (OS), progression-free survival, objective response rate, duration of response, and safety were evaluated among patients in Japan, South Korea, and Taiwan. Patients with stage IV/recurrent NSCLC were randomized 1 : 1 : 1 to nivolumab plus ipilimumab, nivolumab monotherapy, or chemotherapy (PD-L1 ≥1%) or nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy (PD-L1 <1%). Here we report efficacy and safety results for the Asian subpopulation. Nivolumab plus ipilimumab demonstrated clinically meaningful improvement in efficacy versus chemotherapy with a manageable safety profile in patients with advanced non-small cell lung cancer (NSCLC) and tumor programmed death-ligand 1 (PD-L1) expression ≥1% or <1% in Part 1 of CheckMate 227. 17 Seoul National University Bundang Hospital, Seongnam, Republic of Korea.16 Bristol Myers Squibb, Princeton, USA.15 Kurashiki Central Hospital, Kurashiki, Japan.14 Kindai University Hospital, Osaka, Japan.13 Niigata Cancer Center Hospital, Niigata, Japan.12 Okayama University Hospital, Okayama, Japan.11 National Taiwan University Hospital, Hsin-Chu Branch, Hsin-Chu, Taiwan.10 Osaka City General Hospital, Osaka, Japan.Mary's Hospital, Seoul, Republic of Korea. 9 The Catholic University of Korea, Seoul St.7 National Cancer Center Hospital, Tokyo, Japan.6 Saitama Cancer Center, Saitama, Japan.5 Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.4 Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.3 Asan Medical Center, Seoul, Republic of Korea.Electronic address: 2 Chungbuk National University Hospital, Cheongju-si, Republic of Korea. 1 Princess Alexandra Hospital and Queensland University of Technology, Brisbane, Australia.
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