Ipsen provides update on CONTACT-02 Phase III trial in metastatic castration-resistant ...
CONTACT-02 trial showed Cabometyx® + atezolizumab had a positive trend in overall survival but lacked statistical significance. Ipsen will not pursue regulatory submissions for this combination outside the US and Japan. Confidence remains in Cabometyx's profile as a monotherapy and in combination with immunotherapy.
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Ipsen announced final overall survival data from Phase III CONTACT-02 trial, showing a numerical but not statistically significant improvement in OS for Cabometyx® (cabozantinib) plus atezolizumab in metastatic castration-resistant prostate cancer (mCRPC). The trial met the primary endpoint of progression-free survival (PFS). Based on these results, Ipsen will not pursue regulatory submissions for this combination regimen outside the US and Japan. Ipsen remains confident in Cabometyx's profile as a monotherapy and in combination with immunotherapy.
The phase 3 CONTACT-02 trial showed cabozantinib and atezolizumab combination favored over a second novel hormonal therapy in metastatic castration-resistant prostate cancer, though OS trend did not achieve statistical significance. Median OS was 14.8 months vs 15.0 months, with subgroup analysis indicating survival advantage for liver and bone metastasis patients. Safety profile consistent with other trials. Exelixis plans FDA submission, while Ipsen opts not to pursue regulatory submissions outside US and Japan.
CONTACT-02 trial showed Cabometyx® + atezolizumab had a positive trend in overall survival but lacked statistical significance. Ipsen will not pursue regulatory submissions for this combination outside the US and Japan. Confidence remains in Cabometyx's profile as a monotherapy and in combination with immunotherapy.