Date: 2015-08-13
Type of information: Clinical research agreement
Compound: Keytruda® (pembrolizumab)
Company: Merck&Co (USA - NJ) MD Anderson Cancer Center (USA - TX)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: In April 2013, MK-3475 has received a Breakthrough Therapy designation for advanced melanoma from the FDA. Keytruda® is the first approved drug that blocks the PD-1 cellular pathway.monoclonal antibody/immune checkpoint inhibitor. Keytruda® (pembrolizumab - MK-3475) is an investigational, highly selective monoclonal anti-PD-1 antibody designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, MK-3475 enables activation of the immune system’s T-cells that target cancer by essentially releasing a brake on the immune system. MK-3475 is currently being studied in three clinical trials for advanced melanoma including a Phase III trial of MK-3475 versus ipilimumab in ipilimumab-naïve advanced melanoma patients (PN 006). Enrollment is complete in the advanced melanoma cohorts in the company’s Phase IB trial (PN 001) and the Phase II trial (PN 002) comparing two doses of MK-3475 versus chemotherapy in patients with advanced melanoma who have progressed after prior therapy. Pembrolizumab is 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.
Disease: solid tumors
Details: * On August 13, 2015, Merck &Co and The University of Texas MD Anderson Cancer Center announced that they have entered into a strategic clinical research collaboration to evaluate Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab), in combination with other treatments, such as chemotherapy, radiation therapy and/or novel antitumor medicines. Under the terms of the agreement, collaborative studies will be conducted in the following tumor types: gastroesophageal adenocarcinoma, pancreatic adenocarcinoma, and hepatocellular carcinoma -- over the three year period of the collaboration. The first studies are scheduled to start enrolling later this year. The agreement aims to define what combination modalities will work best with Keytruda® in these types of tumors by exploring promising new alternatives. The studies will be conducted in parallel, in order to determine optimal regimens in the most efficient manner possible. All studies will feature state-of-the-art monitoring protocols and built-in flexibility to take advantage of the very latest information available.
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