Another disappointment with Bavencio, this time in lung cancer trial

In another setback for their immuno-oncology drug, Germany’s Merck KGaA (MRK: DE) and Pfizer (NYSE: PFE) announced disappointing results from the Phase III JAVELIN Lung 200 trial comparing Bavencio (avelumab) 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 pre-specified 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 about 40% of the study population) and high PD-L1+ expression population (PD-L1+ expression 80% or greater, which represented around 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.