Merck, Pfizer start Phase III trial of avelumab drug in patients with NSCLC

Under the JAVELIN Lung 100 study, the companies aim to assess the safety and efficacy of avelumab compared with platinum-based doublet chemotherapy, in patients with late-stage NSCLC who have not earlier received any treatment for their systemic lung cancer.

About 420 patients with recurrent or Stage IV PD-L1+ NSCLC will receive either avelumab or the investigator’s choice of platinum-based chemotherapy, based on the patient’s histology as first-line treatment.

The primary endpoint of the study is progression-free survival in previously untreated patients with recurrent or Stage IV programmed death-ligand 1 positive (PD-L1+) NSCLC.

Avelumab is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody that potentially uses the body’s own immune system to fight cancer.

Merck global head of research & development of the biopharma business Luciano Rossetti said: "Through this Phase III trial, we hope to gain a better understanding of avelumab as a potential first-line treatment for non-small cell lung cancer – a prevalent and devastating disease.

"We are working to help patients with this challenging cancer and will continue to develop our NSCLC program by evaluating avelumab as a potential monotherapy and in combination with our extensive portfolios of approved and investigational oncology therapies."

It is the second Phase III study assessing avelumab in NSCLC. The first study, which was started in April this year, is evaluating avelumab in patients whose disease has progressed after receiving a platinum-containing doublet chemotherapy compared with docetaxel.