Exelixis and Ipsen have announced that cabozantinib (CABOMETYX) in combination with atezolizumab met one of two primary endpoints in global Phase 3 CONTACT-02 trial of patients with metastatic castration-resistant prostate cancer (mCRPC).
The late-stage trial evaluated the cabozantinib combination against a second hormonal therapy in mCRPC patients who have measurable soft tissue disease and has been previously treated with one hormonal therapy.
In the trial, the combination showed a statistically significant improvement in progression-free survival (PFS) at the primary analysis.
An improvement in overall survival (OS) was observed at a predetermined interim analysis for the primary endpoint of OS that took place concurrently with the primary analysis of PFS.
Exelixis, a US-based biotechnology company, said that the data were immature to reach the level of statistical significance. Thus, the experiment will proceed as scheduled to the following OS analysis.
Additionally, the combination’s safety profile was consistent with the known safety profiles for each drug and no new safety signals were found with the combination.
Exelixis CMO and Product Development & Medical Affairs EVP Vicki Goodman said: “We are pleased to report positive findings from the CONTACT-02 trial, in which cabozantinib in combination with an immune checkpoint inhibitor has demonstrated an efficacy benefit in another tumour type with significant unmet need.
“We look forward to discussing these findings with the US Food and Drug Administration and to presenting further details at an upcoming medical meeting.”
CONTACT-02 is a global, multicenter, randomised, phase 3, open-label study that recruited 575 patients.
The patients were randomised 1:1 to the experimental arm of cabozantinib in combination with atezolizumab and the control arm of a second novel hormonal therapy.
The two primary endpoints were defined as PFS and OS and the secondary endpoint was objective response rate.
Ipsen Research and Development head and EVP Howard Mayer said: “These results represent the first positive phase 3 data of its kind for a tyrosine kinase inhibitor and immunotherapy combination in this indication.
“We will engage with regulatory authorities on these data and look forward to further exploring the potential treatment benefit for a patient population at such a challenging stage of the disease.”
