Merck and Pfizer have started an international Phase III trial (EMR 100070-004) of its investigational cancer immunotherapy avelumab in patients with stage IIIb/IV non-small cell lung cancer (NSCLC).
The trial is designed to evaluate the efficacy and safety of avelumab compared with docetaxel in these patients who have experienced disease progression after receiving a prior platinum-containing doublet therapy.
In the open-label, multicentre, 1:1 randomised trial patients with stage IIIb/IV NSCLC will receive either avelumab or docetaxel, regardless of PD-L1 status.
Around 650 patients will be enrolled in the trial across 290 sites in more than 30 countries in North America, South America, Asia, Africa and Europe.
EMD Serono, Merck's US and Canadian biopharmaceutical businesses, will be responsible for conducting clinical trials on behalf of Merck in North America.
Merck biopharmaceutical business global head of R&D Dr Luciano Rossetti said: "New and innovative treatment strategies are urgently needed to improve overall survival for patients with NSCLC, and we are investigating avelumab as a potential treatment option for patients with this very difficult-to-treat disease.
"The treatment of the first patient in the Phase III trial is an important milestone for our immuno-oncology alliance."
The Phase III trial is part of the JAVELIN clinical trial programme for avelumab and its primary endpoint is overall survival (OS) in patients with programmed death-ligand 1 positive (PD-L1+) stage IIIb/IV NSCLC who have experienced disease progression after receiving a prior platinum-containing doublet therapy.
Secondary endpoints of the trial will be evaluated across the entire study population regardless of PD-L1 status and include OS; overall response rate (ORR); progression-free survival (PFS); and patient-reported outcomes.
Pfizer Oncology senior vic- president of Clinical Development and Medical Affairs and chief medical officer Dr Mace Rothenberg said: "This trial marks the first of several registration studies we are planning to initiate this year together, and underscores our commitment to accelerating the development of medications for patients with cancer.
"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."