Sun Sep 15 12:45:53 UTC 2024: ## Ipsen Halts Development of Cabometyx and Atezolizumab Combination for Prostate Cancer

**PARIS, FRANCE – September 15, 2024** – Ipsen, a global biopharmaceutical company, announced today that it will not pursue regulatory submissions for the combination of Cabometyx (cabozantinib) and atezolizumab in metastatic castration-resistant prostate cancer (mCRPC). This decision follows the final overall survival (OS) data from the Phase III CONTACT-02 trial, which showed a numerical but not statistically significant improvement in OS for the combination compared to a second novel hormonal therapy (NHT).

While the trial met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant benefit in PFS, Ipsen cited the anticipated challenging regulatory environment as a key factor in its decision.

“We remain confident in the proven profile of Cabometyx as a monotherapy and in combination with immunotherapy across approved indications, as well as its ongoing future potential,” said a spokesperson for Ipsen. “We are grateful to the patients, their families, and healthcare teams who participated in this clinical trial.”

The CONTACT-02 trial enrolled 575 patients with mCRPC who had progressed on one prior NHT. Participants were randomized to receive either the combination of Cabometyx and atezolizumab or a second NHT. The study’s safety profile was consistent with the known safety profiles of the individual medicines, and no new safety signals were identified.

Despite the promising results for PFS, the lack of a statistically significant improvement in OS, coupled with the challenging regulatory landscape, led Ipsen to discontinue the development of this combination regimen for mCRPC. Ipsen will continue to pursue the development of Cabometyx for other indications.

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