After facing setbacks in clinical trials, the combination of Roche’s Tecentriq and Exelixis’ Cabometyx has achieved a breakthrough in treating challenging prostate cancer cases. The joint therapy exhibited positive results in the Phase 3 CONTACT-02 trial, successfully extending the progression-free survival of patients with pretreated metastatic castration-resistant prostate cancer. While one of the primary endpoints was met, demonstrating a substantial improvement, the other primary endpoint, overall survival, showed a promising trend although not yet statistically significant. The trial will continue to assess overall survival as planned, according to Exelixis.
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Safety outcomes remained consistent with the established profiles of both drugs, with no new adverse signals detected when used in combination. This development comes as welcome news for the partnership between Roche and Exelixis, which has encountered challenges in demonstrating the efficacy of this combination in liver and lung cancers in recent times. Their CONTACT-03 trial for kidney cancer, for instance, did not yield positive results.
During the CONTACT-02 trial, 575 enrolled patients were administered either Cabometyx and Tecentriq or an alternative hormonal therapy, including Xtandi or Zytiga. To qualify for the study, patients needed to have measurable soft tissue disease and a history of prior hormonal treatment.
Prostate cancer ranks as the second most prevalent cancer in men and the fourth globally, with around 1.4 million new cases and approximately 375,300 deaths reported in 2020. The promising results of this trial mark a significant advancement, particularly as they showcase the potential of combining a tyrosine kinase inhibitor with immunotherapy, offering hope to patients in advanced stages of the disease.
Howard Mayer, Ipsen’s Executive Vice President and Head of R&D, emphasized the groundbreaking nature of the results, underlining that this combination represents the first instance of a positive Phase 3 outcome for a tyrosine kinase inhibitor and immunotherapy regimen in this specific cancer indication. The data will be shared with regulatory authorities for further assessment, with an eye toward potentially benefiting patients facing this challenging disease stage. This success has the potential to turn the tide for Cabometyx plus Tecentriq, following a series of less successful trials.
In previous trials, the combination had fallen short in kidney cancer, unable to outperform Cabometyx alone in patients who had progressed after initial chemotherapy. The CONTACT-01 study similarly missed its primary endpoint for patients with non-small cell lung cancer that had progressed after immune checkpoint inhibitor and platinum chemotherapy treatment. Additionally, the combination failed to surpass Nexavar from Bayer in extending the lives of patients with previously untreated hepatocellular carcinoma, the most prevalent form of liver cancer.
