Exelixis has announced the detailed results of the CONTACT-02 (NCT04446117) Phase III pivotal trial that assessed the combination of Cabometyx (cabozantinib) and Roche’s Tecentriq (atezolizumab) in the treatment of metastatic castration-resistant prostate cancer (mCRPC).

The findings, presented at the 2024 American Society of Clinical Oncology’s Genitourinary Cancers Symposium, represent the first ever positive Phase III clinical trial of a tyrosine kinase inhibitor and immune checkpoint inhibitor combination with a statistically significant improvement in progression-free survival (PFS) in patients with mCRPC. Cabometyx is a second-generation small-molecule tyrosine kinase inhibitor that targets receptors in the angiogenesis pathway and is approved for renal cell carcinoma, thyroid cancer and hepatocellular carcinoma, but had not previously been indicated for mCRPC.

The trial focused on mCRPC patients with confirmed extra-pelvic soft tissue disease who had progressed after one prior novel hormonal therapy (NHT), such as enzalutamide, apalutamide, darolutamide or abiraterone, but excluded patients who had received chemotherapy. In this patient population, the available treatment options are chemotherapy (docetaxel, cabazitaxel), a second round of NHT and radium-223.

Rising case numbers call for new treatments

The study’s findings revealed that patients treated with Cabometyx and Tecentriq had a 35% lower risk of disease progression or death than those treated with a second NHT. At a median follow-up of 14.3 months, the hazard ratio for PFS was 0.65, with a median PFS of 6.3 months for the combination therapy and 4.2 months for the second NHT. Notably, the control arm may have performed poorly since it did not include all three second-line treatment choices. Furthermore, this trial has a design flaw as it does not include Tecentriq and Cabometyx monotherapy comparison arms, which would have allowed for an evaluation of the combination’s efficacy.

According to a GlobalData epidemiology study, the number of incident cases of prostate cancer in the eight major markets (8MM: China, France, Germany, Italy, Japan, Spain, the UK and the US) will reach 669,245 by 2028, emphasising the need for new treatments. At the time of the analysis, the CONTACT-02 study did not demonstrate statistical significance for overall survival (OS). However, if the OS primary endpoint is met, as may happen later in 2024, the trial’s findings might grant new possibilities for Cabometyx’s use in patients receiving treatment for mCRPC. GlobalData’s consensus analyst forecast projects global Cabometyx sales to exceed $3 billion by 2029.

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By GlobalData