Phase III JAVELIN Lung 200 trial results comparing Bavencio to docetaxel in patients with unresectable, recurrent or metastatic NSCLC. - Merck KGaA + Pfizer.

Merck and Pfizer Inc. announced results from the Phase III JAVELIN Lung 200 trial comparing avelumab (Bavencio) to docetaxel in patients with unresectable, recurrent or metastatic non-small cell lung cancer (NSCLC) whose disease progressed after treatment with a platinum-containing doublet therapy. While the trial did not meet its prespecified endpoint of improving overall survival (OS) in patients with programmed death ligand-1-positive (PD-L1+) (1% or higher) tumors (HR: 0.90 [96% CI: 0.72�1.12], p-value 0.1627, one-sided), the proportion of patients in the chemotherapy arm crossing over to immune checkpoint inhibitors outside the study was higher than previously reported in post-platinum immunotherapy clinical trials, and this may have confounded this trial outcome (percentage of patients receiving subsequent checkpoint inhibitor therapy: docetaxel arm 26.4%; avelumab arm 5.7%).

However, improvements in OS versus the control arm were observed in the moderate-to-high PD-L1+ expression (50% or greater, which represented approximately 40% of the study population) and high PD-L1+ expression population (PD-L1+ expression 80% or greater, which represented approximately 30% of the study population) (HR: 0.67 [95% CI: 0.51�0.89], p-value 0.0052, two-sided; and HR 0.59 [95% CI: 0.42�0.83], p-value 0.0022, two-sided, respectively). The safety profile for avelumab in this trial was consistent with that observed in the overall JAVELIN clinical development program; no new safety signals were identified.

Detailed results from the JAVELIN Lung 200 trial will be submitted for presentation at an upcoming medical congress, and the companies aim to share the data with regulatory agencies.