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Merck KGaA and Pfizer move avelumab into late-stage trials

Begin phase III studies of the monoclonal antibody in lung cancer

Merck KGaA and Pfizer have begun phase III trials of their non-small cell lung cancer (NSCLC) candidate avelumab.  

The monoclonal antibody will be compared with platinum-based doublet chemotherapy in NSCLC patients who have not previously received any treatment.

Dr Luciano Rossetti, head of global research and development at Merck, 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 programme by evaluating avelumab as a potential monotherapy and in combination with our extensive portfolios of approved and investigational oncology therapies.”

The companies plan to enrol around 420 patients into the study, which will encompass 240 sites in Africa, the Americas, Asia and Europe.

The primary endpoint of the study is to evaluate avelumab in progression-free survival in patients with PD-L1+ tumors. Secondary endpoints include overall survival, objective response rate, quality of life, tolerability and safety.

Granted fast-track designation in October by the FDA, avelumab is a fully human anti-PD-L1 IgG1 monoclonal antibody that potentially uses the body's own immune system to fight cancer.

Earlier this week, Boehringer Ingelheim also started phase III trials of its EGFR inhibitor BI 1482694, which is targeted towards patients with NSCLC when other therapies have failed.

Lung cancer is the most common form of the disease worldwide, accounting for between 85% and 90% of all cancers. 

6th November 2015

From: Research



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