WCLC 2017: Pembrolizumab Plus CC-486 for NSCLC
The addition of CC-486, an oral formulation of the epigenetic modifier azacitidine, to pembrolizumab did not appear to improve progression-free survival in previously treated patients with advanced non–small cell lung cancer (NSCLC). Results from this double-blind, phase II study led by Luis Paz-Ares, MD, PhD, of the Hospital Universitario 12 De Octubre, Madrid, were presented at the 2017 International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (Abstract MA 02.02) in Yokohama, Japan.
Patients with stage III/IV NSCLC who received one prior platinum-based chemotherapy were randomized 1:1 to receive pembrolizumab plus CC-486 (n=51) or pembrolizumab plus placebo (n=49). No significant difference was found in median progression-free survival between the CC-486 group and the placebo group at 3.1 and 4 months, respectively.
Patients in the combination-therapy group experienced higher rates of treatment-emergent adverse events, including nausea (14%), vomiting (12%), asthenia (10%), and diarrhea (8%) versus diarrhea (6%), asthenia (6%), and pneumonia (6%) in the placebo arm. Dose interruptions and discontinuations were more prevalent in the experimental group.
The investigators noted that the treatment-emergent adverse events, particularly vomiting and nausea, are known to be associated with CC-486 and may have influenced treatment exposure.