Merck has teamed up with privately-held Syndax Pharmaceuticals to test combining Syndax’s investigational epigenetic therapy, entinostat, with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab), in cancer patients.
The companies announced that they have entered into a clinical trial collaboration to evaluate the safety and efficacy of this novel combination regimen in patients with either advanced non-small cell lung cancer (NSCLC) or melanoma. The companies expect the Phase Ib/II study to start enrolling patients in the second half of 2015. Merck and Syndax could also exercise an option to extend the collaboration to include a Phase III study.
Financial terms of the agreement were not disclosed.
Syndax’s entinostat is an oral highly selective histone deacetylase (HDAC) inhibitor granted Breakthrough Therapy Designation in combination with hormone therapy in advanced hormone receptor positive (HR+) breast cancer currently in Phase III studies for this indication. In preclinical models, entinostat has shown to reduce the number and function of host immune suppressor cells thereby enhancing the anti-tumor activity of immune checkpoint blockade. Merck’s Keytruda is a humanized monoclonal antibody that blocks the interactions between programmed death receptor-1 (PD-1) and its ligands PD-L1 and PD-L2. It was the first anti-PD-1 therapy approved in the US.
“We are excited to be working with Merck on this collaboration to evaluate the potential of these two novel therapies to improve clinical outcomes for patients,” said Arlene Morris, president and chief executive officer of Syndax. “We hope that entinostat in combination with Keytruda may build upon the enormous promise of immunotherapy in treating multiple forms of cancer.”
The Phase Ib/II clinical trial will be conducted in two parts. The Phase Ib portion is designed to evaluate the safety and tolerability of entinostat in combination with Keytruda and the Phase II portion is designed to evaluate the efficacy of the combination in patients with advanced NSCLC and melanoma.
“The broad base of clinical data involving our anti-PD-1 therapy Keytruda continues to provide a strong foundation for advancing the study of different novel combination regimens,” said Dr. Eric Rubin, vice president and therapeutic area head oncology early-stage development Merck Research Laboratories. “Our collaboration with Syndax is an important example of this effort and our commitment to further the study of breakthrough science in the area of immuno-oncology to help people with cancer.”
Last updated: 3/31/15; 2:40pm EST