Abstract 1311P
Background
In the randomized, phase 3 CheckMate 9LA study (NCT03215706), NIVO + IPI + 2 cycles of chemo significantly improved overall survival (OS) vs chemo in 1L advanced NSCLC. Here we present results in the Asian subpopulation.
Methods
Adults with treatment-naive, histologically confirmed stage IV/recurrent NSCLC, ECOG performance status 0–1, and no known sensitizing EGFR/ALK alterations were randomized 1:1 to NIVO (360 mg every 3 wk) + IPI (1 mg/kg every 6 wk) + 2 cycles of histology-based chemo or 4 cycles of chemo. Pts were stratified by PD-L1 expression (< 1% vs ≥ 1%), sex, and histology (squamous vs non-squamous). Pemetrexed maintenance was optional for pts with non-squamous NSCLC in the chemo-only arm. Pts received immunotherapy until disease progression, unacceptable toxicity, or for ≤ 2 y. The primary endpoint was OS. The Asian subpopulation included pts from China and Japan.
Results
Of 58 pts in the Asian subpopulation, 28 were randomized to NIVO + IPI + chemo and 30 to chemo. At database lock (March 9, 2020), minimum follow-up for OS was 12.7 mo. In the NIVO + IPI + chemo arm, 57.1% of pts receieved subsequent chemo and in the chemo arm, 66.7% of pts received subsequent immunotherapy. The hazard ratio (HR) for OS was 0.33 (95% CI, 0.14–0.80) in favor of NIVO + IPI + chemo; additional efficacy results are shown in the table. Grade 3–4 treatment-related adverse events (TRAEs) occurred in 57.1% (NIVO + IPI + chemo) and 60.0% (chemo) of pts, and any-grade TRAEs leading to discontinuation in 21.4% and 16.7%. Among TRAEs typically associated with chemo, the most common were anemia (NIVO + IPI + chemo vs chemo: 28.6% vs 50.0%), alopecia (21.4% vs 26.7%), and neutropenia (7.1% vs 13.3%).
Conclusions
The Asian subpopulation of CheckMate 9LA, although small, demonstrated improved efficacy including OS for 1L NIVO + IPI + chemo vs chemo alone, despite high rates of subsequent immunotherapy in the chemo arm, with a manageable safety profile Table: 1311P
Efficacy in the Asian subpopulation of CheckMate 9LA
| Outcome | NIVO + IPI + chemo (n = 28) | Chemo (n = 30) |
| OS, median (95% CI), mo HR (95% CI) | NR (15.4–NR) 0.33 (0.14–0.80) | 13.3 (8.2–NR) – |
| 6-mo OS, % | 100 | 83 |
| 12-mo OS, % | 93 | 60 |
| PFS, median (95% CI), mo HR (95% CI) | 8.4 (4.2–13.7) 0.47 (0.24–0.92) | 5.4 (2.8–6.9) – |
| 6-mo PFS, % | 62 | 35 |
| 12-mo PFS, % | 35 | 12 |
| Objective response rate, n (%) | 16 (57) | 7 (23) |
| Disease control rate, n (%) | 25 (89) | 23 (77) |
mo, months; NR, not reached; PFS, progression-free survival.
.Clinical trial identification
NCT03215706; July 12, 2017.
Editorial acknowledgement
Writing and editorial assistance was provided by Laura Yee, of Caudex, funded by Bristol-Myers Squibb Company.
Legal entity responsible for the study
Bristol-Myers Squibb Company.
Funding
Bristol-Myers Squibb Company.
Disclosure
T. John: Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: AstraZeneca ; Advisory/Consultancy: Roche; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Merck. 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. K. Kasahara: Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Speaker Bureau/Expert testimony: MSD; Speaker Bureau/Expert testimony: Eli Lilly; Speaker Bureau/Expert testimony: Chugai Pharmaceuticals; Speaker Bureau/Expert testimony, Research grant/Funding (self): Boehringer Ingelheim. Y. Sato: Speaker Bureau/Expert testimony: Chugai Phamaceuticals; Speaker Bureau/Expert testimony: MSD; Speaker Bureau/Expert testimony: Ono Pharmaceutical; Speaker Bureau/Expert testimony: Novartis; Speaker Bureau/Expert testimony: Taiho Pharmaceutical. Y. Nakahara: Honoraria (self): Ono Pharmaceutical; Honoraria (self), Research grant/Funding (self): Bristol-Myers Squibb Company; Honoraria (self), Research grant/Funding (self): Eli Lilly; Honoraria (self): Chugai Pharmaceutical; Honoraria (self): Boehringer Ingelheim GmbH; Honoraria (self): Merck Sharp & Dohme; Research grant/Funding (self): Takeda Pharmaceutical Company Limited. M. Takeda: Speaker Bureau/Expert testimony: Ono Pharmaceutical ; Speaker Bureau/Expert testimony: Boehringer Ingelheim Japan Inc.; Speaker Bureau/Expert testimony: Novartis Pharma K.K. H. Kaneda: Honoraria (self): Bristol-Myers Squibb Company. M. Maemondo: Speaker Bureau/Expert testimony: Bristol-Myers Squibb Company; Speaker Bureau/Expert testimony: Ono Pharmaceutical. M. Satouchi: Honoraria (self): AstraZeneca; Honoraria (self): MSD; Honoraria (self): Chugai ; Honoraria (self): Taiho; Honoraria (self): Pfizer; Honoraria (self): Nippon kayaku; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Bristol-Myers Squibb Company; Honoraria (self): Ono Pharmaceutical; Honoraria (self): Eli Lilly; Honoraria (self): AbbVie; Honoraria (self): Ignyta; Honoraria (self): Takeda; Honoraria (self): Novartis. 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): AstraZeneca; Honoraria (self), Research grant/Funding (self): Bristol-Myers Squibb Company; Honoraria (self), Research grant/Funding (self): Ono Pharmaceutical; 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; Research grant/Funding (self): Astellas. A. Li: Shareholder/Stockholder/Stock options, Full/Part-time employment: Bristol-Myers Squibb Company. S. Lu: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): AstraZeneca; Advisory/Consultancy: Boehringer Ingelheim; Research grant/Funding (self): Hutchison ; Advisory/Consultancy: MediPharma; Advisory/Consultancy: Simcere; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Roche; Speaker Bureau/Expert testimony: Hanseng; Research grant/Funding (self): Bristol-Myers Squibb Company; Research grant/Funding (self): Heng Rui ; Advisory/Consultancy: Hutchison MediPharma. All other authors have declared no conflicts of interest.