Assessments
PD‐L1, death, tumor, Tumor, Treatment‐relatedness, Tumors, TRAEs, Cancer
ADVERSE EVENT, DISEASE PROGRESSION, TUMOR, TUMOR, ADVERSE EVENTS, TUMORS, CPS, EVENTS, CANCER
Incidence of death, treatment‐related adverse events (TRAEs), serious adverse events, TRAEs leading to discontinuation and TRAEs with potential immunologic etiology were assessed using the Medical Dictionary for Regulatory Activities version 23.0, and adverse events (AEs) were graded in severity using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. AEs included events reported between the first dose and 30 days after the last dose of study therapy. Treatment‐relatedness could refer to nivolumab, at least one chemotherapy component or both in the nivolumab plus chemotherapy group. Tumors were assessed by computed tomography or magnetic resonance imaging at baseline, then every 6 weeks from first dose for 48 weeks, then every 12 weeks until disease progression.Tumor cell PD‐L1 expression and PD‐L1 CPS were assessed using the Dako PD‐L1 IHC 28‐8 pharmDx assay (Dako, an Agilent Technologies Inc. company, Santa Clara, CA) at two central laboratories. Tumor cell PD‐L1 expression was defined as the percentage of viable tumor cells with partial or complete membrane staining in at least 100 viable tumor cells. CPS was generated by re‐scoring PD‐L1 stained slides and was defined as the number of PD‐L1‐positive tumor cells with partial or complete membrane staining, plus lymphocytes and macrophages with membrane staining, intracellular staining or both, divided by the total viable tumor cells multiplied by 100.The all randomized patient population included all patients that were concurrently randomized to receive nivolumab plus chemotherapy or chemotherapy. The primary population included all randomized patients with PD‐L1 CPS ≥5. ORR was evaluated for all randomized patients with at least one measurable or target lesion at baseline. The safety population included all patients that received at least one dose of assigned study treatment.