Date: 2014-08-02
Type of information: Initiation of development program
phase: 1b
Announcement:
Company: Merck&Co (USA - NJ) Pfizer (USA - NY)
Product: combination of XALKORI® (crizotinib) and pembrolizumab
Action
mechanism: Pembrolizumab (MK-3475) is an investigational, humanized, monoclonal antibody against PD-1 designed to reactivate anti-tumor immunity. Pembrolizumab exerts dual ligand blockade of the PD-1 pathway by inhibiting the interaction of PD-1 on T cells with its ligands PD-L1 and PD-L2. Pembrolizumab is currently being evaluated across more than 30 types of cancers, as monotherapy and in combination. It is anticipated that by the end of 2014, the pembrolizumab development program will grow to more than 24 clinical trials, enrolling an estimated 6,000 patients at nearly 300 clinical trial sites worldwide. XALKORI® (crizotinib) is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
Disease: ALK-positive advanced or metastatic non-small cell lung cancer (NSCLC)
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On August 26, 2014, Pfizer and Merck & Co. announced that they have entered into an agreement to explore the therapeutic potential of the combination of Pfizer’s crizotinib (Xalkori®) with Merck’s investigational anti-PD-1 antibody pembrolizumab, in a Phase 1b clinical study evaluating the safety and tolerability of the combination in patients with ALK-positive advanced or metastatic non-small cell lung cancer (NSCLC). The financial terms of the agreement were not disclosed. This multi-center, open-label clinical study is expected to begin in 2015. Pfizer will conduct the study. Both companies previously announced plans to evaluate the safety and efficacy of pembrolizumab in combination with Pfizer’s small molecule kinase inhibitor axitinib (INLYTA®) in patients with renal cell carcinoma. Separately, pembrolizumab plus Pfizer’s PF-05082566 (PF-2566), an investigational immuno-oncology agent that targets the human 4-1BB receptor, will be evaluated in multiple cancer types. These studies are expected to begin enrollment later this year.
