Merck KGaA acquires worldwide rights from Debiopharm for phase III stage xevinapant to treat carcinoma of the head and neck.

Merck KGaA, announced a worldwide in-licensing agreement with Debiopharm, Lausanne, Switzerland, for the development and commercialization of xevinapant (Debio 1143). Xevinapant, a potent oral Inhibitor of Apoptosis Proteins (IAP) antagonist, is the only medicine in its class in late-stage clinical development and has the potential to be first in class. Xevinapant is currently being investigated in the Phase III TrilynX study for previously untreated high-risk locally advanced squamous cell carcinoma of the head and neck (LA SCCHN), in combination with platinum-based chemotherapy and standard fractionation intensity-modulated radiotherapy. Under the terms of the licensing agreement, Merck gains exclusive rights to develop and commercialize xevinapant worldwide, including in the U.S. Merck will co-fund with Debiopharm the ongoing Phase III registrational TrilynX study, a global double-blind, placebo-controlled, 700-patient randomized clinical trial to evaluate the efficacy and safety of xevinapant vs. placebo when added to definitive chemoradiotherapy (CRT) in cisplatin-eligible patients with high-risk LA SCCHN (locally advanced squamous cell carcinoma of the head and neck). Merck also will initiate a second global Phase III study to evaluate xevinapant in patients with LA SCCHN who are unable to tolerate high-dose cisplatin in combination with radiotherapy. The agreement also includes development rights for preclinical follow-on compounds to xevinapant. Debiopharm will receive € 188 million in upfront payments and up to € 710 million in regulatory and commercial milestones, as well as royalty payments. The parties anticipate the closing of the transaction in early Q2 2021.