Merck and Incyte to initiate Keytruda, epacadostat combo trial
pharmafile | October 15, 2015 | News story | Research and Development | Incyte, Merck, R&D, melanoma, phase III, skin cancer
Merck and biopharma firm Incyte are to expand their clinical collaboration to include a Phase III study evaluating the combination of the two company’s treatments for melanoma.
The trial will combine epacadostat, Incyte’s investigational selective IDO1 inhibitor, with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, as first-line treatment for patients with advanced or metastatic melanoma.
The Phase III study, which is expected to begin in the first half of 2016, will be co-funded by both companies. Under the terms of the agreement, Incyte and Merck have also agreed, for a period of two years, not to initiate new pivotal studies of an IDO1 inhibitor in combination with a PD-1/PD-L1 antagonist as first-line therapy in advanced or metastatic melanoma with any third party.
During the two years, the companies will each offer the other the opportunity to collaborate on any new pivotal study involving an IDO1 inhibitor in combination with a PD-1/PD-L1 antagonist for types of melanoma and lines of therapy outside of the current collaboration agreement.
Epacadostat and Keytruda are both immunotherapies that target distinct regulatory components of the immune system. Preclinical evidence suggests that the combination of these two agents may lead to an enhanced anti-tumour immune response compared with either agent alone.
IDO1 is an immunosuppressive enzyme that has been shown to induce regulatory T cell generation and activation, and allow tumours to escape immune surveillance. Keytruda is a humanised monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
“We are very pleased to expand our collaboration with Merck and to move the clinical development program for epacadostat in combination with Keytruda into Phase III,” says Hervé Hoppenot, president and chief executive officer of Incyte. “We believe the combination of these two immunotherapies shows promise and, if successfully developed, may help to improve clinical outcomes for patients with metastatic melanoma.”
“The initiation of this large Phase III study with Incyte in the first-line advanced melanoma treatment setting is an important addition to our robust immunotherapy clinical development program for Keytruda,” adds Dr Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories.
“We continue to explore the benefit that Keytruda brings to patients suffering from advanced melanoma when used alone, and we are pleased to be able to add this important combination study with epacadostat to our Keytruda development program.”
Safety and efficacy data from the ongoing Phase I/II study evaluating the combination of epacadostat with Keytruda in patients with advanced malignancies is scheduled to be presented at the upcoming Society for Immunotherapy of Cancer annual meeting in early November.
Joel Levy
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