Most patients (pts) with locally advanced, unresectable non-small cell lung cancer (NSCLC) progress despite concurrent chemoradiation therapy (cCRT). Here we report interim results from a global, Phase 3 study of the anti-PD-L1 durvalumab as consolidation therapy in Stage III pts without progression following platinum-based cCRT.
Pts with a WHO performance status 0/1 (any PD-L1 status) who received ≥2 cycles of platinum-based cCRT without progression were randomized (2:1) 1–42 days post-cCRT to receive durvalumab 10 mg/kg IV Q2W or placebo for up to 12 months, stratified by age, sex, and smoking history. Co-primary endpoints were progression-free survival (PFS; blinded independent central review, RECIST v1.1) and overall survival (OS). Secondary endpoints included 12- and 18-month PFS rates, objective response rate (ORR), duration of response (DoR), time to death or distant metastasis (TTDM) and safety.
Between May 2014 and April 2016, 713 pts were randomized of whom 709 received consolidated treatment (durvalumab, n = 473; placebo, n = 236). Baseline characteristics were well balanced. As of Feb 13, 2017 (data cutoff), median follow-up was 14.5 months. Median PFS from randomization was significantly longer with durvalumab (16.8 months, 95% CI, 13.0–18.1) versus placebo (5.6 months, 95% CI, 4.6–7.8; stratified HR 0.52, 95% CI, 0.42–0.65; P
Durvalumab demonstrated significant and clinically meaningful improvement in PFS, which was supported by secondary endpoints, and was well tolerated. Durvalumab is a promising therapeutic option in this setting.
Clinical trial identification
NCT02125461 (April 25, 2014).
Legal entity responsible for the study
A. Villegas: Speaker honoraria from Celgene, Alexion, and Bristol-Myers Squibb. R. Hui: Advisory board fees from AstraZeneca, Merck Sharp and Dohme, and Novartis, and a speaker honorarium from Merck Sharp and Dohme. A. Chiappori: Speaker honoraria from Genentech, Merck, Takeda, Novartis, Pfizer, Boehringer Ingelheim, and Celgene, and research support from Novartis and Bristol-Myers Squibb. M. de Wit: Seaker honorarium from AstraZeneca. T. Mekhail: Speaker honorarium and research support from AstraZeneca. D. Planchard: Advisory board fees from AstraZeneca, Bristol-Myers Squibb, Merck Sharp and Dohme, Pfizer, Novartis, Roche, Lilly, and Boehringer Ingelheim. H. Jiang, Y. Huang, P.A. Dennis: Full-time employee of AstraZeneca with stock ownership. S.J. Antonia: Advisory board fees from AstraZeneca.
All other authors have declared no conflicts of interest.