Merck KGaA and Pfizer announce initiation of second Phase III trial of avelumab for treatment-na�ve advanced NSCLC patients

Merck and Pfizer announced the initiation of an international Phase III study of the investigational cancer immunotherapy avelumab in a treatment-naïve advanced NSCLC setting. The study, JAVELIN Lung 100, is designed to assess the safety and efficacy of avelumab compared with platinum-based doublet chemotherapy, in patients with late-stage NSCLC who have not previously received any treatment for their systemic lung cancer.

Avelumab (previously known as MSB0010718C) is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody that potentially uses the body’s own immune system to fight cancer. The Phase III study is an open-label, multicentre, randomised clinical trial in which patients with recurrent or Stage IV PD-L1+ NSCLC will receive either avelumab or the investigator’s choice of platinum-based chemotherapy, depending on the patient’s histology (either squamous or non-squamous), as first-line treatment. Patients will be pre-screened for PD-L1+ status using an immunohistochemistry-based companion diagnostic test.

The study expects to enroll approximately 420 patients across more than 240 sites in Africa, America (North and South), Asia and Europe. Clinical trials in North America on behalf of Merck KGaA will be conducted by EMD Serono, the company’s US and Canadian biopharma business. The primary endpoint of the study is progression-free survival in patients with PD-L1+ tumours. Secondary endpoints include progression-free survival in patients with strongly PD-L1 positive (PD-L1++) tumours, overall survival, objective response rate, quality of life, tolerability and safety in patients treated with avelumab versus investigator-choice chemotherapy.

Comment: This is the second randomised Phase III study of avelumab in NSCLC initiated in just over six months; the first study was initiated in April 2015 and is evaluating avelumab in patients whose disease has progressed after receiving a platinum-containing doublet chemotherapy compared with docetaxel.