On September 17, 2024 Takeda reported detailed final overall survival (OS) results from CONTACT-02, a phase 3 pivotal study led by Exelixis, evaluating cabozantinib (CABOMETYX) in combination with atezolizumab, an immune checkpoint inhibitor, compared with a second novel hormonal therapy (NHT) in patients with metastatic castration-resistant prostate cancer (mCRPC) and measurable extra-pelvic soft tissue disease who have progressed on one prior NHT (Press release, Takeda, SEP 17, 2024, View Source [SID1234646704]). These data were presented by Neeraj Agarwal, M.D. of the Huntsman Cancer Institute at the University of Utah, USA on September 15 at the 2024 European Society for Medical Oncology Congress (ESMO 2024) during the Proffered Paper Session: GU Tumors, Prostate.
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The dual primary endpoints for CONTACT-02 were progression-free survival (PFS) and OS. At a median follow-up of 24.0 months, the final analysis of OS showed a numerical but not statistically significant improvement favoring cabozantinib in combination with atezolizumab (hazard ratio: 0.89; 95% confidence interval: 0.72-1.10; P=0.296). An improvement in OS was observed in multiple clinical subgroups, notably in patients with bone or liver metastases, with the latter category representing a population whose disease may be evolving away from androgen receptor signaling.
As previously announced, CONTACT-02 met the other dual primary endpoint, demonstrating a statistically significant benefit in PFS in the predefined PFS ITT population (i.e., the first 400 randomized patients). Detailed results were presented by Neeraj Agarwal, M.D. at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Genitourinary Cancers Symposium in January 2024.
The CONTACT-02 Trial
CONTACT-02 is a phase III, randomized, open-label, controlled trial of cabozantinib plus atezolizumab versus a second new hormone therapy in patients with metastatic castration-resistant prostate cancer. Exelixis is leading the CONTACT-02 trial, which is co-funded by Roche. Both Ipsen, Exelixis’ partner and Takeda have committed to participation in the trial and are funding it under the terms of their respective collaboration agreements with Exelixis.
Cabometyx(Cabozantinib)
Cabometyx is a drug created and developed by Exelixis. It has been approved in the United States for the treatment of advanced renal cell carcinoma and for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib. It has also been approved in the European Union and in other countries and regions. In Japan, Cabometyx was approved by the Ministry of Health, Labour and Welfare in March 2020 for the treatment of unresectable or metastatic renal cell carcinoma, and was launched in May of the same year under the brand names of Cabometyx Tablets 20 mg and 60 mg. In November 2020, Takeda received approval for a partial change to the manufacturing and marketing approval for Cabometyx, specifically for the treatment of unresectable hepatocellular carcinoma that has worsened after chemotherapy. In August 2021, the company received a further approval for a partial change to the manufacturing and marketing approval for Cabometyx as a combination therapy with nivolumab for the treatment of unresectable or metastatic renal cell carcinoma.