Exelixis and Ipsen Announce Positive Phase 3 CONTACT-02 Trial Results for Cabozantinib Plus Atezolizumab in Metastatic Castration-Resistant Prostate Cancer

▎WuXi

Edited by Kant Content Team

Exelixis and Ipsen Announce CONTACT-02 Global Pivotal Phase 3 Trial Met One of Two Primary EndpointsExelixis and Ipsen today announced that the global pivotal phase 3 trial CONTACT-02 met one of two primary endpoints. In patients with metastatic castration-resistant prostate cancer (mCRPC), treatment with cabozantinib (commercial name: Cabometyx) in combination with Tecentriq (atezolizumab), a PD-L1 inhibitor developed by Roche, demonstrated a statistically significant reduction in the risk of disease progression or death compared to novel hormone therapy. Additionally, an improvement trend in overall survival (OS) was observed at the first interim analysis.

Prostate cancer is the fourth most common cancer globally and the second most common cancer in men. In 2020, there were over 1.4 million new cases of prostate cancer worldwide, resulting in approximately 375,000 deaths. mCRPC is defined as prostate cancer that has spread beyond the prostate and does not respond to standard androgen deprivation therapies used for prostate cancer. Patients with mCRPC typically have a poor prognosis, with an estimated survival of 1-2 years.

Cabozantinib can inhibit multiple tyrosine kinases, including MET, VEGFR-1, 2, 3, AXL, RET, ROS1, KIT, etc., which are receptor tyrosine kinases associated with tumor generation, metastasis, angiogenesis, and drug resistance.Cabozantinib has been approved in the United States for the treatment of advanced renal cell carcinoma, as a first-line therapy for advanced renal cell carcinoma in combination with the PD-1 antibody nivolumab, and for the treatment of hepatocellular carcinoma (HCC) patients who have previously received sorafenib therapy, among other indications. In 2016, Exelixis granted Ipsen exclusive rights to commercialize and further clinically develop cabozantinib outside of the United States and Japan. Exelixis holds exclusive rights to develop and commercialize cabozantinib in the United States.

The purpose of the CONTACT-02 trial is to evaluate the efficacy and safety of cabozantinib in combination with atezolizumab compared to novel hormone therapy in patients with mCRPC who have previously received one novel hormone therapy, with measurable visceral disease or measurable extra-pelvic adenopathy. A total of 575 patients were enrolled.CONTACT-02 Pivotal Trial Meets One of Two Primary Endpoints, Key Analysis Shows Statistically Significant Improvement in Progression-Free Survival (PFS). An Interim Analysis of the Primary Endpoint, Overall Survival (OS), Reveals a Trend Towards Improvement.; however, the data are not yet mature and have not reached the threshold for statistical significance. Therefore, the trial will continue as planned for the next overall survival analysis.

The safety profile of the combination of cabozantinib and atezolizumab is consistent with the known safety profiles of each monotherapy, and no new safety signals were identified with the combination.