According to a press release from Business Wire, the oncology company Exelixis recently presented the final overall survival (OS) results from its Phase 3 clinical trial CONTACT-02. This trial was evaluating a combination treatment of cabozantinib (marketed as CABOMETYX) and atezolizumab (Tecentriq®) against a second novel hormonal therapy in people living with prostate cancer that is metastatic and castration-resistant. These patients also had measurable extra-pelvic disease of soft tissue and had progressed on a previous novel hormonal therapy.
This clinical trial included a total of 575 patients that were randomized to receive either the study combination or the second novel hormonal therapy. The endpoints of the trial were overall survival and progression-free survival (PFS). After a median follow-up period of two years, the analysis demonstrated that patients on the study combination showed better overall survival. However, under the parameters of the trial, this improvement was not considered statistically significant. Regardless, an improvement was observed across multiple groups of patients, including individuals with liver and bone metastases.
In earlier data reporting from this year that was presented in January, the data reported statistically significant improvements in PFS, meaning that the trial was able to meet this endpoint successfully. Patients receiving the study combination experienced grade 3-4 adverse events 40% of the time.
The treatment landscape for metastatic castration-resistant prostate cancer remains dire, especially in cases involving liver metastases. As a result, even modest advances have the potential to have important impacts on patient survival and outcomes. The company plans to file for approval with the US Food and Drug Administration (FDA) by the end of the year.
About Prostate Cancer
Prostate cancer occurs in the prostate gland, part of the male reproductive system that is positioned beneath the bladder. Risk factors for prostate cancer include old age, a family history of the disease, and being of African ancestry. Tumors can appear on the prostate as cells accumulate DNA mutations, but most do not become cancerous. In early stages, prostate cancer doesn’t cause symptoms, but as the disease progresses, difficulty urinating, erectile dysfunction, and bloody urine or semen can appear. Fatigue, bone or back pain, or unexpected weight loss are signs of metastatic disease. Treatment for prostate cancer can vary widely depending on risk and severity of the individual case. Options can include surgical removal of the prostate, hormone therapy, or radiation therapy. Chemotherapy is often used when the disease has spread. Due to screening programs, prostate cancer is often detected at an early stage, and in these cases, patients can have relatively long survival times after diagnosis. To learn more about prostate cancer, click here.
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Last modified: September 23, 2024
