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news.Merck and Syndax Pharmaceuticals have entered into a clinical trial collaboration to evaluate the safety and efficacy of the combination of entinostat and Keytruda (pembrolizumab) in a Phase Ib/II trial in patients with either advanced non-small cell lung cancer (NSCLC) or melanoma.
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Syndax’s entinostat is an oral, highly selective histone deacetylase (HDAC) inhibitor, while Keytruda is Merck’s first anti-PD-1 therapy approved in the US.
Keytruda is a humanized monoclonal antibody that blocks the interaction between programmed death receptor-1 (PD-1) and its ligands, PD-L1 and PD-L2.
Patient enrolment in the Phase Ib/II trial is expected to be initiated in the second half of 2015.
Entinostat has been granted breakthrough therapy designation in combination with hormone therapy in advanced hormone receptor positive (HR+) breast cancer and currently in Phase III testing in this indication.
In preclinical models, entinostat has been shown to reduce the number and function of host immune suppressor cells thereby enhancing the anti-tumor activity of immune checkpoint blockade.
The clinical trial deal also includes a provision where the companies may extend the collaboration to include a potential Phase III clinical trial.
The planned multicenter, open-label Phase Ib/II clinical trial will be conducted in two parts, with the Phase Ib portion is designed to determine the safety and tolerability of entinostat in combination with Keytruda.
The trial’s Phase II portion is designed to assess the efficacy of entinostat combined with Keytruda in patients with advanced NSCLC and melanoma.
Merck Research Laboratories vice-president and therapeutic area head, oncology early-stage development Dr Eric Rubin said: "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.
"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."
In the US, Keytruda is indicated at a dose of 2mg/kg administered as an intravenous infusion over 30 minutes every three weeks to treat patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
Image: Keytruda is indicated at a dose of 2mg/kg administered as an intravenous infusion in the US. Photo: courtesy of Baitong333/ freedigitalphotos.net.