German pharmaceutical giant Merck has signed a licensing deal with Swedish biotechnological company Debiopharm International for global development and commercialization of Debiopharm’s late-stage asset Debio 1143 (xevinapant) in head and neck squamous cell carcinoma (HNSCC).

HNSCC is the sixth most common cancer and is a highly debilitating disease causing significant orofacial impairments in advanced stages. Around 40–60% of patients with locally advanced disease develop recurrence or locoregional or distant metastases.

Xevinapant, a first-in-class immunomodulatory enzyme inhibitor, is being developed in the US in Phase III clinical trial TrilynX (NCT04459715) for use in combination with platinum-based chemotherapy and standard fractionation radiotherapy for patients with previously untreated locally advanced unresectable HNSCC. In Debiopharm’s recent data release on its investigational oncology program (including xevinapant) at the European Society of Medical Oncology (ESMO) 2020, the company unveiled successful results from its Phase II trial assessing the safety and efficacy of the drug.

Xevinapant showed a significant improvement in overall survival, with a three-year overall survival rate of 66%, as well as a 51% reduced risk for mortality and an increased progression-free survival rate and superior duration of response. The FDA granted xevinapant a Breakthrough Therapy Designation (BTD).

Key opinion leaders interviewed by GlobalData were positive about the developments, and the treatment is expected to demonstrate substantial improvements in clinical outcomes.

This $1.08B deal involves a $237M upfront payment and $850M in regulatory milestones as well as royalty payments to Debiopharm, along with Merck’s pledge to co-fund the ongoing Phase III TrilynX study, in exchange for exclusive global marketing rights to xevinapant. This collaboration could transform the current treatment paradigm for HNSCC by combining this new molecular entity with Merck KGaA’s strong commercialization capabilities.

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By GlobalData

The past few years have seen several licensing deals globally for clinical development in head and neck cancer. This deal-making landscape is expected to foster further research and development, global business development, and ultimately sharing of science.

GlobalData reports approximately 340 licensing agreements as of 2021, beginning as early as 2004, in head and neck cancer amounting to an approximate total value of $35B, with the highest recorded deals in North America at a $10B valuation with a year-on-year growth rate of 33%. GlobalData analysis reveals a robust late-stage pipeline for HNSCC that will encourage more licensing and commercialization partnerships, which should contribute to significant market growth over the next decade.