10.13.15
Incyte Corp. and Merck have expanded their ongoing clinical collaboration to include a Phase III study evaluating the combination of epacadostat, Incyte’s investigational selective IDO1 inhibitor, with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, as first-line treatment for advanced or metastatic melanoma. The Phase III study, which is expected to begin in 1H16, will be co-funded by Incyte and Merck.
The companies have also agreed, for a period of two years, not to initiate new 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. Each company will have the opportunity to collaborate on any new pivotal study involving this combination for types of melanoma and lines of therapy outside of the current collaboration.
“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,” said 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,” said 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.”
The companies have also agreed, for a period of two years, not to initiate new 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. Each company will have the opportunity to collaborate on any new pivotal study involving this combination for types of melanoma and lines of therapy outside of the current collaboration.
“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,” said 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,” said 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.”