Avelumab Versus Docetaxel in Patients With Platinum-Treated Advanced NSCLC: 2-Year Follow-Up From the JAVELIN Lung 200 Phase 3 Trial

IntroductionIn the JAVELIN Lung 200 trial, avelumab (anti-programmed death-ligand 1 [PD-L1] antibody) did not significantly prolong overall survival (OS) versus docetaxel in patients with platinum-treated PD-L1+ NSCLC. We report greater than 2-year follow-up data.MethodsPatients stage IIIB or IV recurrent NSCLC disease progression after platinum-doublet chemotherapy were randomized 1:1 to 10 mg/kg every 2 weeks 75 mg/m2 3 weeks. The primary end point was OS tumors (greater equal 1% tumor cell expression; IHC 73-10 pharmDx assay).ResultsOf 792 patients, 529 had (264 265 arms, respectively). As of March 4, 2019, median duration for population 35.4 months arm and 34.7 arm; study treatment ongoing 25 (9.5%) 0 respectively. In population, rates (95% confidence interval [CI]) 29.9% (24.5%–35.5%) 20.5% (15.6%–25.8%); 50% subgroups, 36.4% (29.1%–43.7%) 17.7% (11.8%–24.7%) 80% subgroup 40.2% (31.3%–49.0%) 20.3% (12.9%–28.8%), Median response (investigator assessed) 19.1 CI: 10.8–34.8) 5.7 4.1–8.3). Safety profiles both arms consistent analysis.ConclusionsAlthough analysis (reported previously) revealed that NSCLC, posthoc analyses at years doubled subgroups higher PD-L1 expression 80%).