Found 1 Presentation For Request " 1274P"
1274P - First-line (1L) nivolumab (NIVO) plus ipilimumab (IPI) in Asian patients (pts) with advanced non-small cell lung cancer (aNSCLC) in CheckMate 227
- Kenneth J. O'Byrne (Woolloongabba, QLD, Australia)
Abstract
Background
In CheckMate 227 Part 1 (NCT02477826), 1L treatment with NIVO + IPI improved overall survival (OS) vs platinum-doublet chemotherapy (chemo) in pts with aNSCLC. Safety was manageable and consistent with the known profile of NIVO + IPI in NSCLC. We report results in the Asian subpopulation of CheckMate 227.
Methods
Pts with stage IV/recurrent NSCLC, ECOG performance status 0–1, no sensitizing
Results
A total of 121 Asian pts were randomized to NIVO + IPI and 124 to chemo; baseline characteristics were generally balanced between arms. Minimum follow-up for OS was 29.7 mo (database lock, July 2, 2019). Asian pts with PD-L1 ≥ 1% had a 24% reduction in risk of death with NIVO + IPI vs chemo; hazard ratio (HR) for OS was 0.76 (95% CI, 0.49–1.17; Table). Median progression-free survival (PFS) was 11.0 mo with NIVO + IPI vs 6.7 mo with chemo (HR, 0.64 [95% CI, 0.43–0.95]). Objective response rates were 54% with NIVO + IPI and 37% with chemo; median duration of response was 26.1 mo and 6.9 mo, respectively. Among all randomized Asian pts (PD-L1 ≥ 1% + < 1%), improved efficacy with NIVO + IPI vs chemo was also observed (Table). Grade 3–4 treatment-related adverse events (TRAEs) were reported in 40% of pts with NIVO + IPI vs 36% with chemo. Any-grade TRAEs leading to discontinuation occurred in 22% vs 13% of pts, respectively. Updated results with a 3-y minimum follow-up will be presented.
Conclusions
As with the global population of CheckMate 227, the Asian subpopulation had improved efficacy with NIVO + IPI vs chemo as 1L treatment for aNSCLC. Safety in the Asian subpopulation was consistent with the global population. Efficacy in the Asian subpopulation of CheckMate 227 NR, not reached.
Pts with PD-L1 ≥ 1% NIVO + IPI (n = 81) Chemo (n = 81) OS, median (95% CI), mo HR (95% CI) NR (16.6–NR) 0.76 (0.49–1.17) 24.8 (19.5–32.5) – 1-y OS, % 79 77 2-y OS, % 56 51 PFS, median (95% CI), mo HR (95% CI) 11.0 (5.5–19.6) 0.64 (0.43–0.95) 6.7 (4.4–7.4) – ORR, n (%) 44 (54) 30 (37) DOR, median (95% CI), mo 26.1 (15.0–NR) 6.9 (3.9–11.1) OS, median (95% CI), mo HR (95% CI) NR (17.8–NR) 0.68 (0.49–0.96) 22.9 (18.2–26.4) – 1-y OS, % 76 68 2-y OS, % 53 45 PFS, median (95% CI), mo HR (95% CI) 8.5 (5.5–11.1) 0.66 (0.48–0.90) 5.6 (4.5–7.0) – ORR, n (%) 57 (47) 41 (33) DOR, median (95% CI), mo 24.5 (15.0–NR) 5.6 (3.7–6.9)
Clinical trial identification
NCT02477826; June 23, 2015.
Editorial acknowledgement
Writing and editorial assistance was provided by Laura Yee, PhD, of Caudex, funded by Bristol-Myers Squibb Company.
Legal entity responsible for the study
Bristol-Myers Squibb Company.
Funding
Bristol-Myers Squibb Company.
Disclosure
K.J. O'Byrne: Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Boehringer Ingelheim; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Advisory/Consultancy, Speaker Bureau/Expert testimony: Janssen-Cilag; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: MSD; Advisory/Consultancy: Natera; Advisory/Consultancy: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche-Genentech; Advisory/Consultancy: Teva; Speaker Bureau/Expert testimony: Mundipharma; Shareholder/Stockholder/Stock options: Carp Pharmaceuticals; Shareholder/Stockholder/Stock options: Carpe Vitae Pharmaceutical; Licensing/Royalties: Various patents issues with licensee as listed. Queensland University of Technology and Trinity College Dublin. K. Park: Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy: Amgen; Speaker Bureau/Expert testimony: AstraZeneca Research Fund; Advisory/Consultancy: Blueprint; Advisory/Consultancy: Bristol-Myers Squibb Company; Advisory/Consultancy, Speaker Bureau/Expert testimony: Boehringer Ingelheim; Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Advisory/Consultancy: Daiichi Sankyo; Advisory/Consultancy: Eli Lilly; Advisory/Consultancy: Hanmi; Advisory/Consultancy: Incyte; Advisory/Consultancy: Janssen; Advisory/Consultancy: Loxo; Advisory/Consultancy: Merck KGaA; Advisory/Consultancy: ONO; Advisory/Consultancy: Roche. M. Nishio: Honoraria (self), Research grant/Funding (institution): Chugai Pharmaceutical; Honoraria (self), Research grant/Funding (institution): AstraZeneca; Honoraria (self), Research grant/Funding (institution): Ono Pharmaceutical; Honoraria (self), Research grant/Funding (institution): Bristol-Myers Squibb Company; Honoraria (self), Research grant/Funding (institution): Pfizer; Honoraria (self), Research grant/Funding (institution): Eli Lilly; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Taiho Pharmaceutical; Honoraria (self), Research grant/Funding (institution): Boehringer Ingelheim; Honoraria (self), Research grant/Funding (institution): MSD; Honoraria (self), Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution): Daiichi Sankyo Healthcare; Research grant/Funding (institution): Merck Serono; Research grant/Funding (institution): Astellas. H. Sakai: Advisory/Consultancy, Speaker Bureau/Expert testimony: Bristol-Myers Squibb Company; Speaker Bureau/Expert testimony: Ono Pharmaceutical; Speaker Bureau/Expert testimony: Chugai Pharmaceutical; Speaker Bureau/Expert testimony: AstraZeneca; Speaker Bureau/Expert testimony: Merck & Co; Speaker Bureau/Expert testimony: Merck KGaA. Y. Ohe: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): AstraZeneca; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Chugai; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): ONO; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Bristol-Myers Squibb Company; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Bayer; Honoraria (self), Research grant/Funding (self): Pfizer; Honoraria (self): MSD; Honoraria (self), Research grant/Funding (self): Taiho; Honoraria (self), Advisory/Consultancy: Nippon Kayaku; Honoraria (self), Advisory/Consultancy: Kyowa Hakko Kirin ; Advisory/Consultancy, Research grant/Funding (self): Kyorin; Advisory/Consultancy: Celltrion; Advisory/Consultancy: Amgen; Research grant/Funding (self): Dainippon- Sumitomo; Research grant/Funding (self): Kissei; Research grant/Funding (self): Daiichi Sankyo; Research grant/Funding (self): Janssen; Research grant/Funding (self): Loxo; J-H. Kang: Advisory/Consultancy, Research grant/Funding (self): AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy, Research grant/Funding (self): Ono; Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Advisory/Consultancy: Amgen; Speaker Bureau/Expert testimony: Merck; Speaker Bureau/Expert testimony: Boehringer Ingelheim; Advisory/Consultancy: Eli Lilly. H. Daga: Honoraria (self): Chugai. K. Hotta: Honoraria (self): Pfizer; Honoraria (self), Research grant/Funding (self): Eli Lilly; Honoraria (self), Research grant/Funding (self): MSD; Honoraria (self), Research grant/Funding (self): Bristol-Myers Squibb Company; Honoraria (self): Ono; Honoraria (self): NipponKayaku; Honoraria (self): Taiho; Honoraria (self): Boehringer Ingelheim; Honoraria (self), Research grant/Funding (self): Chugai; Honoraria (self): Novartis; Honoraria (self): DaiichiSankyo; Honoraria (self): Kyorin; Honoraria (self): KyowahHakko-Kirin; Honoraria (self), Research grant/Funding (self): AstraZeneca; Research grant/Funding (self): Astellas. H. Tanaka: Honoraria (self): Bristol-Myers Squibb Company. M. Takeda: Speaker Bureau/Expert testimony: Ono Pharmaceutical ; Speaker Bureau/Expert testimony: Boehringer Ingelheim Japan Inc.; Speaker Bureau/Expert testimony: Novartis Pharma K.K. . T. Yokoyama: Honoraria (self): AstraZeneca; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Bristol-Myers Squibb Company; Honoraria (self): Ono Pharmaceutical; Honoraria (self): Novartis; Honoraria (self): Pfizer; Honoraria (self): Chugai Pharmaceutical .F.E. Nathan: Shareholder/Stockholder/Stock options: AstraZeneca; Shareholder/Stockholder/Stock options: Gilead Sciences; Shareholder/Stockholder/Stock options: Johnson & Johnson; Shareholder/Stockholder/Stock options: Eli Lilly; Full/Part-time employment: Bristol-Myers Squibb Company. All other authors have declared no conflicts of interest.