Merck and Pfizer begin new Phase III avelumab trial in lung cancer
pharmafile | November 5, 2015 | News story | Medical Communications, Research and Development | Merck, Pfizer, avelumab, lung cancer, non-small cell lung cancer
Merck and Pfizer have commenced an international Phase III study of the investigational cancer immunotherapy avelumab in patients with non-small cell lung cancer.
The JAVELIN Lung 100 study 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 – Merck’s lead immuno-oncology compound – is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody that potentially uses the body’s own immune system to fight cancer.
Merck partnered with Pfizer to jointly develop and commercialise avelumab in order to accelerate both companies’ presence in immuno-oncology.
The two companies at the time said they would combine resources and expertise to advance Pfizer’s anti-PD-1 antibody and accelerate the development of avelumab in multiple tumour types. The companies will collaborate on up to 20 high priority immuno-oncology clinical development programs with avelumab.
JAVELIN Lung 100 is expected to enrol approximately 420 patients across more than 240 sites in Africa, North and South America, Asia and Europe. Clinical trials in North America on behalf of Merck 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 will 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.
“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,” says Dr Luciano Rossetti, the global head of R&D in Merck’s biopharma business. “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.”
“There is great promise for the use of immunotherapy in the treatment of non-small cell lung cancer and this new trial underscores our continuing commitment to investigating potential immune-based treatment options for this devastating disease,” says Dr Mace Rothenberg, senior vice president of clinical development and medical affairs and chief medical officer for Pfizer oncology. “The clinical development program for avelumab continues to accelerate, and the initiation of this Phase III study represents another important achievement in 2015 for the alliance between Merck KGaA and Pfizer.”
The first study of avelumab in NSCLC 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.
Joel Levy
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