Merck and Pfizer Initiate Phase III Study with Avelumab in Patients with Stage IIIb/IV Non-Small Cell Lung Cancer

22-Apr-2015 - Germany

Merck and Pfizer 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, multicenter, 1:1 randomized 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. In North America, clinical trials on behalf of Merck will be conducted by EMD Serono, the company’s US and Canadian biopharmaceutical businesses. 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.

https://www.bionity.com/en/news/152547/merck-and-pfizer-initiate-phase-iii-study-with-avelumab-in-patients-with-stage-iiib-iv-non-small-cell-lung-cancer.html