- Thursday brought the latest immunotherapy failure in lung cancer, with Pfizer Inc. and partner Merck KGaA announcing that their PD-L1 inhibitor Bavencio failed to improve overall survival in the Phase 3 JAVELIN Lung 200 study.
- JAVELIN tested the checkpoint inhibitor against docetaxel in patients with unresectable, recurrent or metastatic non-small cell lung cancer (NSCLC) whose disease progressed after chemo.
- The companies noted, though, that patients with high levels of the biomarker PD-L1 showed improvement in overall survival compared with the control arm of the study.
Widely considered the most important market for cancer drugs due to the high prevalence, non-small cell lung cancer has been a sticky area for the highly touted immunotherapy compounds.
While market leaders from Merck & Co. and Bristol-Myers Squibb Company have racked up a number of indications (as well as billions in sales), igniting the fervor for the PD-1/L1 inhibitors, many of the compounds in the class have struggled in lung cancer in one way or another.
New Jersey-based Merck's Keytruda (pembrolizumab) is currently the only one of these drugs to garner an approval in the first-line lung cancer setting.
Still, Keytruda hasn't gotten a lock on this market yet and new data from the slew of competitors in the space could shake things up.
Interestingly, Pfizer and partner Germany-based Merck pointed to a high percentage of patients in the docetaxel arm of the Bavencio (avelumab) study that were subsequently treated with other checkpoint inhibitors, potentially skewing the results. The primary investigator of the study said in a statement that this new trend in treatment might have "confounded the primary outcome of the study."
"Avelumab’s overall clinical activity in this study supports its profile with expected efficacy across several endpoints and subgroups," added Luciano Rossetti, Merck KGaA's global head of R&D. "However, the chemotherapy group displayed improved overall survival compared with previous PDx trials, most likely due to the impact of crossover to other checkpoint inhibitors."
Further results from the study will be presented at an upcoming medical meeting.