Ipsen SA (IPSEY) said its Phase III CONTACT-02 study evaluating Cabometyx in combination with Genetech's approved cancer treatment atezolizumab, for the treatment of metastatic castration-resistant prostate cancer (mCRPC), failed to meet one of the primary endpoints of overall survival.
The study investigated the combination regimen versus a second novel hormonal therapy (NHT) in men previously treated with one NHT and measurable soft-tissue disease.
At a median follow-up of 24 months, data showed that there was no statistical improvement in overall survival in patients treated with the combination regimen compared to those on a second NHT.
As previously announced, the study had met the other primary endpoint of progression-free survival.
Ipsen said it will not pursue regulatory submissions for this combination regimen in mCRPC in countries where it has commercialization rights.
Cabometyx, developed by Exelixis, is already approved for advanced renal cell carcinoma, hepatocellular carcinoma, and differentiated thyroid carcinoma. Exelixis had granted Ipsen rights for the commercialization and development of Cabometyx outside of the U.S. and Japan.
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