US pharma giants Pfizer (NYSE: PFE) and Merck & Co (NYSE: MRK) have inked an agreement to explore the therapeutic potential of the combination of Pfizer’s Xalkori (crizotinib) with Merck’s investigational anti-PD-1 antibody pembrolizumab.
The companies plan a Phase Ib clinical study evaluating the safety and tolerability of the combination in patients with ALK-positive advanced or metastatic non-small cell lung cancer (NSCLC). This multicenter, open-label clinical study is expected to begin in 2015. Pfizer will conduct the study. The financial terms of the agreement were not disclosed.
Xalkori, which has annual sales of $400 million was approved in 2011 for lung cancer patients who have a specific mutation in the so-called ALK gene, as determined by an approved diagnostic test (The Pharma Letter August 30, 2011) and was cleared for the treatment of patients with metastatic ALK-positive non-small cell lung cancer (NSCLC) as detected by a US Food and Drug Administration-approved test (TPL November 22, 2013).
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