Merck and The University of Texas MD Anderson Cancer Center announced 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 anti-tumor medicines.
Under the terms of the agreement, collaborative studies will be conducted in the following tumor types over the three year period of the collaboration: gastroesophageal adenocarcinoma, pancreatic adenocarcinoma, and hepatocellular carcinoma. 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.
"Through these types of collaborations, we are able to engage in larger, more comprehensive studies that aim to accelerate the pace of discovery," said Patrick Hwu, M.D., division head, Cancer Medicine at MD Anderson. "We believe that this new agreement will help to speed delivery of new cancer treatments that our patients expect and deserve."
"This agreement embodies Merck's commitment to collaborating with leaders in the field to rapidly advance breakthrough science and further the goal of bringing new treatment approaches to patients," said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. "Agreements like this are an integral part of our strategy to evaluate KEYTRUDA in multiple tumors and combinations."
MD Anderson been instrumental in researching breakthrough cancer therapies, and was a key contributor to early investigations exploring the use of KEYTRUDA in the treatment of multiple tumor types. Past research collaborations with Merck and MD Anderson were pivotal in achieving the FDA approval of KEYTRUDA as a treatment for unresectable or metastatic melanoma.
KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, KEYTRUDA releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.
KEYTRUDA is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Merck is advancing a broad and fast-growing clinical development program for KEYTRUDA with more than 100 clinical trials - across more than 30 tumor types and enrolling more than 16,000 patients - both as a monotherapy and in combination with other therapies.