Debiopharm Grants Merck Global Exclusive License for Xevinapant Development and Commercialization

Lausanne, Switzerland, March 5, 2021 /PRNewswire/ --DebiopharmOuYesA global biopharmaceutical company headquartered in Switzerland today announced the signing of an exclusive licensing agreement with leading technology company Merck for the development and commercialization of xevinapant (Debio 1143). Xevinapant is a potent oral inhibitor of apoptosis protein (IAP) antagonist and the only candidate in its class currently in late-stage clinical development, with the potential to become a best-in-class therapy. Currently, xevinapant is being evaluated in the pivotal Phase III TrilynX study, which assesses its efficacy in combination with platinum-based chemotherapy and standard fractionated intensity-modulated radiation therapy (IMRT) in patients with previously untreated, high-risk, locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). Given Merck’s strong commercial footprint in the field of head and neck cancers, its ability to effectively leverage our robust Phase II data made it our preferred partner, positioning xevinapant as a transformative treatment option for cancer patients.

Under the terms of the license agreement, Merck KGaA has obtained exclusive global rights (including in the United States) to develop and commercialize xevinapant. Merck KGaA will also co-fund the ongoing Phase III registrational TrilynX study with Debiopharm Group. This study is a double-blind, placebo-controlled, global randomized clinical trial involving 700 patients, designed to evaluate the efficacy and safety of xevinapant versus placebo when added to definitive chemoradiotherapy (CRT) in patients with high-risk locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are eligible for cisplatin.

This global licensing agreement represents a significant achievement and a testament to Debiopharm’s clinical development efforts, while also demonstrating the flexibility and relevance of the Company’s specialized and unique business model. By focusing on drug development, Debiopharm connects the most innovative discoveries with the best commercial pharmaceutical partners.

“At Debiopharm, our therapeutic ambition drives us forward. Our business model is guided by patient needs and unmet medical needs. To date, data on xevinapant have demonstrated significant potential to improve the standard of care for patients with head and neck cancer, a field that has seen no new treatment approvals for decades.”CEO of DebiopharmBertrand Ducrey“Merck’s deep understanding of head and neck cancers, combined with its global commercial capabilities, makes it an excellent partner to advance xevinapant and position it as the next gold-standard therapy for head and neck cancers and other indications.”

“By applying our expertise and heritage in head and neck cancer to the development of xevinapant, we have the opportunity to explore an important new therapeutic option in this area of high unmet need, where existing treatments—including immunotherapy—have shown limited efficacy.”Member of the Executive Board of Merck, CEO of the Healthcare SectorPeter Guenterindicated.“Xevinapant demonstrated robust long-term efficacy in Phase II clinical studies, indicating that IAP antagonism has the potential to become a transformative approach for this cancer. Building on the strong proof of concept from Debiopharm’s robust xevinapant clinical development program, we will continue to advance this potential new standard of care.”

“Locally advanced head and neck cancer is particularly debilitating, often impairing swallowing, speech, and respiratory functions. According to current standard treatment methods, at least half of the patients will experience recurrence within the first two years. Based on the efficacy results from the Phase II study, adding xevinapant to CRT can reduce the risk of death by half, suggesting that this investigational drug has the potential to provide a much-needed new standard of care.”Director of the Department of Radiation Oncology, Lausanne University Hospital,TrilynXofIIIPrincipal Investigator of Phase StudiesJean BourhisThe professor stated.

Previously reported results from a randomized, double-blind Phase II clinical study demonstrated that the addition of xevinapant to standard-of-care chemoradiotherapy (CRT) resulted in a statistically significant 21% improvement in the primary endpoint of local control rate at 18 months in patients with high-risk locally advanced squamous cell carcinoma of the head and neck (LA SCCHN), compared with placebo plus CRT (54% [95% CI: 39–69] vs. 33% [95% CI: 20–48]; odds ratio 2.69 [95% CI: 1.13–6.42]; p=0.026). After 2 years of follow-up, progression-free survival (PFS) was significantly improved compared with the control group (HR=0.37, 95% CI: 0.18–0.76;p=0.0069）¹。During the three-year follow-up, xevinapant plus CRT was associated with a statistically significant 51% reduction in the risk of death compared with placebo plus CRT (HR=0.49, 95% CI: 0.26–0.92; p=0.0261). Approximately two-thirds of patients in the xevinapant group remained alive at year 3, compared with 51% in the control group.

In February 2020, the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to xevinapant, based on Phase II results, for use in combination with current standard of care, platinum-based chemotherapy, and standard fractionated intensity-modulated radiotherapy, for the treatment of patients with previously untreated, locally advanced squamous cell carcinoma of the head and neck (LA SCCHN).

¹ Sun XS, Tao Y, Le Tourneau C, et al. Debio 1143 and high-dose cisplatin chemoradiotherapy in high-risk locoregionally advanced squamous cell carcinoma of the head and neck: a double-blind, multicentre, randomised, phase 2 study. Lancet Oncol 2020; 21: 1173-1187.