Efficacy
death, PD‐L1
CPS, MAY
After a minimum follow‐up (time from concurrent randomization of the last patient to data cutoff [May 27, 2020]) of 12.1 months, Chinese patients with PD‐L1 CPS ≥5 in the nivolumab plus chemotherapy group had a 46% reduction in risk of death and a 5.9‐month improvement in median OS (15.5 months [95% CI: 11.9‐25.5] vs 9.6 months [95% CI: 8.0‐12.1]; HR 0.54 [95% CI: 0.36‐0.79]) vs the chemotherapy group, respectively. Patients with PD‐L1 CPS ≥1 had a 38% reduction in risk of death (HR 0.62 [95% CI: 0.43‐0.87]) and a 4.4‐month improvement in median OS (14.3 months [95% CI: 11.5‐17.5] vs 9.9 months [95% CI: 8.1‐12.1]) vs the chemotherapy group. OS was also improved for all randomized patients in the nivolumab plus chemotherapy group, with a 4.0‐month improvement of median OS (14.3 months [95% CI: 11.5‐17.5] vs 10.3 months [95% CI: 8.1‐12.1]) as well as a 39% reduction in risk of death (HR 0.61 [95% CI: 0.44‐0.85]) vs the chemotherapy group. The 12‐month OS rates were numerically higher in the nivolumab plus chemotherapy group vs the chemotherapy group in all patient populations, at 61% (95% CI: 49‐71) vs 41% (95% CI: 30‐52) for PD‐L1 CPS ≥5, 57% (95% CI: 46‐67) vs 42% (95% CI: 32‐52) for PD‐L1 CPS ≥1 and 57% (95% CI: 46‐66) vs 43% (95% CI: 33‐52) for all randomized patients, respectively (Figure Overall survival in Chinese patients. Overall survival in patients with PD‐L1 CPS ≥5 (A), PD‐L1 CPS ≥1 (B) and in all randomized patients (C). Chemo, chemotherapy; CI, confidence interval; CPS, combined positive score; HR, hazard ratio; mo, months; NIVO, nivolumab; OS, overall survival; PD‐L1, programmed death ligand 1The median PFS per BICR for patients with PD‐L1 CPS ≥5 treated with nivolumab plus chemotherapy vs chemotherapy was improved by 4.2 months (8.5 months [95% CI: 5.9‐12.4] vs 4.3 months [95% CI: 4.1‐6.5]; HR 0.52 [95% CI: 0.34‐0.77]) with a 48% reduction in risk of progression or death. The median PFS for patients with PD‐L1 CPS ≥1 was improved in the nivolumab plus chemotherapy group by 3.4 months (8.3 months [95% CI: 6.0‐12.3] vs 4.9 months [95% CI: 4.1‐6.8]; HR 0.57 [95% CI: 0.40‐0.82]) with a 43% reduction in risk of progression or death vs the chemotherapy group, respectively. Similarly, all randomized patients had a 2.7‐month improvement in median PFS with nivolumab plus chemotherapy (8.3 months [95% CI: 6.2‐12.3]) vs chemotherapy (5.6 months [95% CI: 4.2‐6.8]; HR 0.57 [95% CI: 0.40‐0.80]) with a 43% reduction in risk of progression or death. PFS rates at 12 months were numerically higher in the nivolumab plus chemotherapy group, at 42% (95% CI: 30‐53) vs 16% (95% CI: 9‐26) for PD‐L1 CPS ≥5, 40% (95% CI: 29‐50) vs 16% (95% CI: 9‐25) for PD‐L1 CPS ≥1 and 40% (95% CI: 30‐50) vs 16% (95% CI: 9‐25) for all randomized patients, respectively (Figure Progression‐free survival in Chinese patients. Progression‐free survival per BICR in patients with PD‐L1 CPS ≥5 (A) and PD‐L1 CPS ≥1 (B) and in all randomized patients (C). BICR, blinded independent central review; chemo, chemotherapy; CI, confidence interval; CPS, combined positive score; HR, hazard ratio; mo, months; NIVO, nivolumab; PD‐L1, programmed death ligand 1; PFS, progression‐free survivalAn objective response per BICR occurred in 47 patients (68% [95% CI: 56‐79]) treated with nivolumab plus chemotherapy and in 34 patients (48% [95% CI: 36‐60]) treated with chemotherapy in the PD‐L1 CPS ≥5 subgroup with 12 (17%) vs 9 patients (13%) experiencing a complete response, respectively. In all randomized patients, an objective response occurred in 58 patients (66% [95% CI: 55‐76]) treated with nivolumab plus chemotherapy and in 44 patients (45% [95% CI: 35‐56]) treated with chemotherapy, and complete responses occurred in 13 (15%) and 9 patients (9%), respectively (Supplementary Table The HRs for OS consistently favored the nivolumab plus chemotherapy group over the chemotherapy alone group across multiple prespecified subgroups (Supplementary Figure Among all randomized patients, 47% in the nivolumab plus chemotherapy group and 59% in the chemotherapy group received subsequent therapy; 3% and 10% received subsequent immunotherapy, respectively (Supplementary Table 