![]() 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. John: Advisory/Consultancy: Bristol-Myers Squibb Advisory/Consultancy: AstraZeneca Advisory/Consultancy: Roche Advisory/Consultancy: Novartis Advisory/Consultancy: Pfizer Advisory/Consultancy: Merck. Writing and editorial assistance was provided by Laura Yee, of Caudex, funded by Bristol-Myers Squibb Company. Mo, months NR, not reached PFS, progression-free survival. 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: 1311PĮfficacy in the Asian subpopulation of CheckMate 9LA Outcome 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%). 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%. 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. 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. At database lock (March 9, 2020), minimum follow-up for OS was 12.7 mo. Of 58 pts in the Asian subpopulation, 28 were randomized to NIVO + IPI + chemo and 30 to chemo. The Asian subpopulation included pts from China and Japan. Pts received immunotherapy until disease progression, unacceptable toxicity, or for ≤ 2 y. Pemetrexed maintenance was optional for pts with non-squamous NSCLC in the chemo-only arm. Pts were stratified by PD-L1 expression (< 1% vs ≥ 1%), sex, and histology (squamous vs non-squamous). MethodsĪdults 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. Here we present results in the Asian subpopulation. 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. 19 Oncology Department, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai/CN.18 Oncology Clinical Development, Bristol-Myers Squibb Company, Princeton/US.17 Biometrics And Data Sciences, Bristol-Myers Squibb Company, Princeton/US.16 Center For Innovative Clinical Medicine, Okayama University Hospital, Okayama/JP.15 Department Of Thoracic Oncology, Hyogo Cancer Center, Akashi/JP.14 Department Of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, Yokohama/JP.13 Department Of Respiratory Medicine, Gunma University Hospital, Maebashi/JP.12 Department Of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota/JP.11 Division Of Pulmonary Medicine, Allergy, And Rheumatology, Department Of Internal Medicine, Iwate Medical University Hospital, Yahaba/JP.10 Department Of Oncology, Tangdu Hospital, Xi'an/CN.9 Department Of Clinical Oncology, Osaka City University Hospital, Osaka/JP.8 Medical Oncology, Kindai University Hospital, Osaka/JP.7 Department Of Thoracic Oncology, Kanagawa Cancer Center, Yokohama/JP.6 Department Of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe/JP.5 Respiratory Medicine, Kanazawa University Hospital, Kanazawa/JP.4 Department Of Thoracic Oncology, Jilin Cancer Hospital, Changchun/CN.3 Department Of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama/JP.2 Thoracic Oncology Department, Saitama Cancer Center, Saitama/JP.1 Department Of Medical Oncology, Austin Hospital, 3084 - Heidelberg/AU.
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