Abstract 1274P
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 EGFR mutations or known ALK alterations, and no prior systemic therapies were eligible. Pts with PD-L1 ≥ 1% were randomized 1:1:1 to NIVO (3 mg/kg Q2W) + IPI (1 mg/kg Q6W), NIVO alone (240 mg Q2W), or chemo. Pts with PD-L1 < 1% were randomized 1:1:1 to NIVO + IPI, NIVO (360 mg Q3W) + chemo, or chemo. The Asian subpopulation includes pts from Japan, South Korea, and Taiwan.
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. Table: 1274P
Efficacy in the Asian subpopulation of CheckMate 227
| 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) |
| All randomized pts | NIVO + IPI (n = 121) | Chemo (n = 124) |
| 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) |
NR, not reached.
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.