Phase III trial initiated in Merck and Pfizer partnership for renal cell carcinoma drug

pharmafile | April 6, 2016 | News story | Research and Development Merck, Pfizer, avelumab, carcinoma, inlyta, javelin, partnership, phase III, renal 

The first patient has been treated in the Phase III clinical trial, which sees Merck (ETR: MRK) and Pfizer (NYSE: PFE) join forces, to investigate avelumab in combination with tyrosine kinase inhibitor (TKI), Inlyta (axitinib), for the treatment of renal cell carcinoma (RCC).

Renal cell carcinoma accounts globally for 2-3% of all malignancies, with more than 338,000 new cases of kidney cancer diagnosed per year worldwide. The disease has a poor long term outlook with the 5-year survival rate for patients with RCC approximately 12%.

The JAVELIN Renal 101 is the first trial to investigate this combo in patients with previously untreated RCC, and the only Phase III trial currently evaluating an anti-PD-L1 immunotherapy in combination with a vascular endothelial growth factor-receptor TKI in this setting.

The two companies announced the initiation of this Phase III trial in late December, and will evaluate the efficacy of this combination compared to Sutent (sunitinib malate) monotherapy.

Chris Boshoff, vice president at Pfizer Oncology, comments: “As renal cell carcinoma is an immunogenic type of tumour that can respond to immunotherapy and to anti-antiogenic treatment, there is a strong scientific rational for combining avelumab with Inltya and we believe that this combination may help improve outcomes for patients with cancer.”

Alise Reicin, head of global clinical development at Merck, says: “The first patient receiving treatment in this pivotal trial marks an important milestone in the strategic immune-oncology alliance between Merck and Pfizer. As part of the JAVELIN clinical development program, we are exploring the potential of innovative, rational combination therapies, which combine avelumab with other treatment modalities to address significant unmet needs that exist in challenging cancers, such as advanced renal cell carcinoma.”

Sean Murray

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