Sun Sep 15 13:40:11 UTC 2024: ## Exelixis Announces Final Overall Survival Results from CONTACT-02 Study for Advanced Prostate Cancer
**ALAMEDA, Calif.** – Exelixis, Inc. (Nasdaq: EXEL) today announced the detailed final overall survival (OS) results from CONTACT-02, a phase 3 pivotal study evaluating cabozantinib (CABOMETYX®) in combination with atezolizumab (Tecentriq®) for patients with metastatic castration-resistant prostate cancer (mCRPC). These results were presented at the 2024 European Society for Medical Oncology Congress (ESMO 2024).
The study compared the combination therapy to a second novel hormonal therapy (NHT) in patients with mCRPC and measurable extra-pelvic soft tissue disease who had progressed on one prior NHT.
**While the study showed a numerical but not statistically significant improvement in OS favoring the combination therapy, a notable improvement was observed in patients with bone or liver metastases, particularly those with liver metastasis, a population whose disease may be evolving away from androgen receptor signaling.**
“Despite recent advancements, outcomes remain poor for patients with metastatic castration-resistant prostate cancer whose disease progresses after novel hormonal therapy,” said Dr. Neeraj Agarwal, global lead investigator of the trial. “The positive results from CONTACT-02, especially in the subset of patients with liver metastasis, reinforce the therapeutic potential of cabozantinib in combination with atezolizumab for these patients.”
**The study met one of its primary endpoints, demonstrating a statistically significant benefit in progression-free survival (PFS) in the predefined PFS population.**
“Within the current treatment landscape, there is a growing population of patients with metastatic castration-resistant prostate cancer with extra-pelvic soft tissue metastases whose disease has progressed after novel hormonal therapy, leaving a high unmet need for effective, widely available treatments for these patients,” said Dr. Amy Peterson, Chief Medical Officer of Exelixis. “Collectively, the results from the CONTACT-02 trial suggest that there are patients who could benefit from cabozantinib in combination with atezolizumab and that this regimen could be a valuable addition to the treatment landscape for patients with advanced prostate cancer.”
Exelixis intends to submit a supplemental New Drug Application with the U.S. Food and Drug Administration for cabozantinib in combination with atezolizumab for mCRPC later this year.
**About CONTACT-02:**
CONTACT-02 is a global, multicenter, randomized, phase 3, open-label study that randomized 575 patients to either cabozantinib in combination with atezolizumab or a second NHT (either abiraterone and prednisone or enzalutamide). The study included patients with mCRPC who have measurable extra-pelvic soft tissue metastasis and who have progressed on one prior NHT. The secondary endpoint is objective response rate per blinded independent radiology committee.
**About CABOMETYX® (cabozantinib):**
CABOMETYX tablets are approved as monotherapy for the treatment of patients with advanced renal cell carcinoma (RCC) and in combination with nivolumab as a first-line treatment for patients with advanced RCC; for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib; and for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC). CABOMETYX tablets have also received regulatory approvals in over 65 countries outside the U.S. and Japan, including the European Union.
**About Exelixis:**
Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care.
**Disclaimer:** This news article is a summary of the information provided in the original press release and should not be considered medical advice. For specific questions or concerns about prostate cancer or treatment options, please consult a qualified healthcare professional.
First Piper 