German science and technology company Merck have agreed a worldwide in-licensing agreement with Debiopharm for the development and commercialisation of xevinapant, a treatment currently being trialled for advanced squamous cell carcinoma of the head and neck.
The deal grants Merck exclusive global rights, with Debiopharm set to receive €188 million upfront and up to €710 million in regulatory and commercial milestones, as well as royalty payments.
Xevinapant is an oral treatment that inhibits apoptosis proteins, and is the only medicine in its class in late-stage clinical development.
A Phase II trial reported that xevinapant plus chemoradiotherapy reduced risk of death by 51% versus standard care.
A Phase III trial, the TrilynX study, began in September 2020. The trial is investigating xevinapant, in combination with platinum-based chemotherapy and standard fractionation intensity-modulated radiotherapy, in head and neck cancer patients.
Head and neck cancer accounts for more than 650,000 cases and 330,000 deaths annually, making it the sixth most common cancer type worldwide.
Peter Guenter, CEO of Healthcare at Merck, said: ”By bringing our expertise and heritage in head and neck cancer to the development of xevinapant, we have the opportunity to explore an important new treatment option in an area of high unmet need where other approaches, including immunotherapy, have seen limited success.
“The promising long-term efficacy of xevinapant in the Phase II trial suggests that antagonism of IAP [inhibitor of apoptosis proteins] has the potential to be a transformative approach in this cancer.”
Jean Bourhis, Department Head of Radio-Oncology at the University Hospital of Lausanne, and lead investigator of the Phase III TrilynX study, added: “Locally advanced head and neck cancer is uniquely debilitating, often impairing the ability to swallow, speak and breathe. With the current standard treatments, at least half of patients will relapse, typically within the first two years.
“Based on the efficacy seen in the Phase II study, in which adding xevinapant to CRT cut the risk of death by half, this investigational medicine has the potential to offer a much-needed new standard of care.”
Jack Goddard
This is a syndicated feed from Pharmafile
