Merck KGaA gains exclusive rights to Debiopharma’s late-stage oncology asset

German company Merck KGaA has signed an exclusive licence agreement with Swiss biopharma company Debiopharm for its late-stage oncology asset xevinapant.

Xevinapant is a potentially first-in-class oral inhibitor of apoptosis proteins (IAP) antagonists, and is already in late-stage development.

Merck KGaA will pay Debiopharm €188m upfront and up to €710m in regulatory and commercial milestones, as well as royalty payments, for the exclusive rights to xevinapant.

This reflects a total consideration of up to €900m, or $1.08bn for the deal, according to Reuters.

As part of the deal, Merck KGaA will co-fund the ongoing TrilynX study, and will also initiate a second global phase 3 study to evaluate xevinapant in high-risk locally advanced head and neck cancer patients who are unable to tolerate high-dose cisplatin in combination with radiotherapy.

The drug is currently being evaluated in the phase 3 TrilynX study for the treatment of previously untreated high-risk locally advanced head and neck cancer, in combination with chemotherapy and standard fractionation intensity-modulated radiotherapy.

In a phase 2 study of xevinapant, the drug provided a statistically significant 21% point improvement in locoregional control rate at 18 months when added to standard of care in high-risk locally advanced head and neck cancer.

After a two-year follow-up, a ‘significant’ progression-free survival benefit was also observed in the xevinapant-treated arm compared to the control arm.

The drug was granted a US Food and Drug Administration (FDA) breakthrough therapy designation for previously untreated locally advanced head and neck cancer, alongside current standard of care, in February 2020 on the strength of the phase 2 data.

“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,” said Peter Guenter, member of the executive board of Merck KGaA and chief executive officer, healthcare.

“The promising long-term efficacy of xevinapant in the phase 2 trial suggests that antagonism of IAP has the potential to be a transformative approach in this cancer. Looking forward, we will continue to pursue opportunities to augment the in-house innovations in our oncology portfolio with new solutions for patients with cancer,” he added.