IM01.01 4-Year Survival in Randomised Phase II (POPLAR) and Phase III (OAK) Studies of Atezolizumab vs. Docetaxel in 2L+ NSCLC

Atezolizumab (anti–PD-L1) showed overall survival (OS) benefit over docetaxel in the Phase II (POPLAR; N=287) and Phase III (OAK; N=1225) studies in patients with advanced NSCLC. 4-year survival analysis from both studies is reported. In both studies, patients were randomised 1:1 to receive atezolizumab (1200 mg) or docetaxel (75 mg/m2) intravenously every 3 weeks; PD-L1 expression was assessed by the Ventana SP142 assay on tumour cells (TC) and tumourinfiltrating immune cells (IC); landmark OS was estimated using the Kaplan-Meier method. The minimum follow-up was 53 (POPLAR) and 45 (OAK) months, representing an additional 17 and 19 months of follow-up, respectively, from prior reports. 4-year survival rates with atezolizumab vs docetaxel were 14.8% vs 8.1% and 15.5% vs 8.7% in POPLAR and OAK, respectively. The long-term OS benefit of atezolizumab vs docetaxel was seen across histology and PD-L1 expression subgroups. Of patients in the atezolizumab arms who lived ≥4 years in POPLAR (N=15) and OAK (N=43), 40% and 23% were in the PD-L1–high (TC3 or IC3) subgroup, 33% and 37% were in the PD-L1–negative (TC0 and IC0) subgroup, and 87% and 88% had non-squamous histology, respectively. Among 4-year survivors in the docetaxel arms, 2/4 (50%) and 17/26 (65%) received subsequent immunotherapy in POPLAR and OAK, respectively, vs 3/15 (20%) and 10/43 (23%) in the atezolizumab ar Fewer Grade 3-4 treatment-related adverse events and adverse events leading to treatment withdrawal occurred in the atezolizumab vs docetaxel arms in both studies. 4-year OS rates favoured atezolizumab vs docetaxel across histology and PD-L1 expression subgroups in both studies. The PD-L1–high (TC3 or IC3) subgroups continued to derive the greatest OS benefit with atezolizumab vs docetaxel; however, the PD-L1–negative (TC0 and IC0) subgroups also sustained an improved long-term OS benefit with atezolizumab vs docetaxel. Most patients in the docetaxel arms received subsequent immunotherapy. Atezolizumab treatment was well tolerated, and safety was consistent with prior reports. Previously presented at ESMO Congress 2020, FNP: 1907, Julien Mazieres et al. - Reused with permission