Merck KGaA and Pfizer initiate Phase III study with avelumab in patients with stage IIIb/IV non-small cell lung cancer

Merck KGaA and Pfizer have announced the initiation and first patient treated in the international Phase III study (EMR 100070-004) designed to assess the efficacy and safety of the investigational cancer immunotherapy, avelumab (MSB0010718C), compared with docetaxel, 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.

The Phase III study is an open-label, multicentre, 1:1 randomised clinical trial where patients with stage IIIb/IV NSCLC will receive either avelumab or docetaxel, regardless of PD-L1 status. Approximately 650 patients will participate across 290 sites in more than 30 countries in North America, South America, Asia, Africa and Europe. The study is part of the JAVELIN clinical trial program for avelumab.

The primary endpoint of the study 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 will be assessed 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.

“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,” said Dr. Luciano Rossetti, Global Head of R&D of the biopharmaceutical business of Merck KGaA. “The treatment of the first patient in the Phase III trial is an important milestone for our immuno-oncology alliance.”

JAVELIN programme also includes a Phase I trial to investigate avelumab in more than 840 patients with metastatic or locally advanced solid tumours

“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,” said Dr. Mace Rothenberg, Senior Vice President of Clinical Development and Medical Affairs and Chief Medical Officer for Pfizer Oncology. “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.”

The JAVELIN clinical trial programme also includes an international Phase II trial to investigate avelumab in patients with metastatic Merkel cell carcinoma; an international Phase I trial to investigate avelumab in patients with metastatic or locally advanced solid tumours, and a Phase I trial to investigate avelumab in Japanese patients with metastatic or locally advanced solid tumours with an expansion part in Asian patients with gastric cancer. The Phase I program for avelumab includes more than 840 patients treated across multiple tumour types, including NSCLC, breast cancer, gastric cancer, ovarian cancer, bladder cancer, melanoma and mesothelioma.