Merck KGaA and Pfizer have kicked off an international late-stage study pitting the efficacy and safety of their investigational anti PD-L1 antibody avelumab against docetaxel in lung cancer.

The PD-L1/PD-1 pathway is implicated as a major mechanism by which tumours evade elimination by the immune system. Avelumab (formerly MSB0010718C) blocks the interaction of PD-L1 with its receptor PD-1, potentially restoring effective anti-tumour T-cell responses and thereby to inhibiting cancer growth.

The open-label, multi-centre, randomised Phase III clinical trial is looking at the drug’s potential in patients with stage IIIb/IV non-small cell lung cancer (NSCLC) who have experienced disease progression after receiving a prior platinum-containing doublet therapy.

Around 650 patients will participate in the trial, the primary endpoint of which is overall survival (OS) in those testing positive for PD-L1, while secondary endpoints will be assessed across the entire study population - regardless of PD-L1 status - and include OS; overall response rate, progression-free survival; and patient-reported outcomes.

Merck discovered and developed avelumab before forming a strategic alliance with Pfizer in November last year to co-develop and co-commercialise the drug and work together on up to 20 immuno-oncology clinical development programs, several of which are pencilled in to start this year. 

“Through this alliance, we will have the opportunity to combine the promising anti-PD-L1 antibody avelumab with our combined portfolios of approved and investigational oncology therapies, which may provide an exciting opportunity to potentially broaden the use of immunotherapy for patients with cancer,” noted Mace Rothenberg, chief medical officer at Pfizer Oncology.