The treatment combination of Cabometyx (cabozantinib) and Tecentriq (atezolizumab) demonstrated significant improvements regarding survival without disease progression for patients with metastatic castration-resistant prostate cancer (mCRPC), according to preliminary results from a phase 3 trial.
Cabometyx — a tyrosine kinase inhibitor which prevents cancer cell growth — is an oral tablet that has been approved in the United States to treat several diseases, including advanced renal cell carcinoma, locally advanced or metastatic differentiated thyroid cancer and hepatocellular carcinoma for patients who have previously been treated with Nexavar (sorafenib).
Tecentriq is an immune checkpoint inhibitor, which is a type of targeted therapy drug, and is also considered a monoclonal antibody that binds to the protein PD-L1 on the surface of certain cancer cells, preventing the cancer cells from suppressing the immune system, as noted from the National Cancer Institute.
Castration-resistant prostate cancer is when prostate cancer continues growing even though the amount of testosterone in the body reduces to very low levels, according to the National Cancer Institute. Patients with mCRPC also tend to have a poor prognosis, in which survival is estimated to be one to two years, as reported in the journal Clinical Genitourinary Cancer.
According to a press release from biotechnology company Exelixis Inc. and biopharmaceutical company Ipsen, the phase 3 trial CONTACT-02 is currently evaluating Cabometyx plus Tecentriq compared with a novel hormonal therapy as treatment for patients with mCRPC and measurable soft tissue disease who have been previously treated with one novel hormonal therapy.
“These positive findings from CONTACT-02 are highly encouraging given the need for additional, non-cytotoxic or non-chemotherapeutic treatment options for this patient population,” Dr. Neeraj Agarwal, professor and presidential endowed chair of cancer research at Huntsman Cancer Institute, University of Utah and the global lead investigator of the trial, said in the press release. “(Cabometryx) in combination with (Tecentriq) represents a potential new treatment modality for patients with metastatic castration-resistant prostate cancer, and we look forward to sharing the full data at a future medical meeting.”
Preliminary findings from the trial established that the use of Cabometyx combined with Tecentriq has demonstrated a significant improvement in progression-free survival (PFS), defined as the period during and after treatment of cancer when the disease does not worsen, during the primary analysis.
Researchers also assessed overall survival (the period from diagnosis or treatment where patients are still alive), in which Exelixis noted that a trend toward improvement was observed, but the data were not yet of statistical significance.
“Patients with metastatic castration-resistant prostate cancer face a poor prognosis of less than two years, and many who progress on a novel hormonal therapy are seeking alternative treatment options to chemotherapy,” said Dr. Vicki L. Goodman, executive vice president, product development and medical affairs and chief medical officer of Exelixis, in the press release. “We are pleased to report positive findings from the CONTACT-02 trial, in which (Cabometyx) in combination with an immune checkpoint inhibitor has demonstrated an efficacy benefit in another tumor type with significant unmet need. We look forward to discussing these findings with the U.S. Food and Drug Administration and to presenting further details at an upcoming medical meeting.”
“With prostate cancer confirmed as the second most commonly occurring cancer in men globally, the need for innovative new therapies is extensive, especially for those whose cancer has progressed to the metastatic castration-resistant form,” said Howard Mayer, executive vice president and head of research and development at Ipsen, in the press release. “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 disease.”
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