After a losing streak in the clinic, Roche and Exelixis’ combo of Tecentriq and Cabometyx has delivered a trial win in tough-to-treat prostate cancer.
Roche’s immuno-oncology star Tecentriq—plus Exelixis and Ipsen’s tyrosine kinase inhibitor Cabometyx—helped patients with pretreated metastatic castration-resistant prostate cancer live longer without their disease getting worse, the partners said Monday. In turn, the combo therapy hit one of two primary endpoints in the phase 3 CONTACT-02 trial.
As for the other primary endpoint—the oncology gold standard of overall survival—a “trend toward improvement” was observed, the companies said. The data were immature and did not meet the threshold for statistical significance at the time of the progression-free survival readout, Exelixis said in a press release.
The trial will continue to the next analysis of overall survival as planned, the company added.
Safety was on par with the previously established profiles for both drugs, and no new signals were identified with the combination.
The partial win is good news for Roche and Exelixis’ combo regimen, which has struggled to prove its worth in liver cancer and lung cancer in recent years. Most recently, the combo flopped its CONTACT-03 trial in kidney cancer in March.
Based on trial design details published in 2022, statistical significance in either progression-free survival or overall survival would be enough to declare victory for the Cabometyx-Tecentriq combination in prostate cancer, according to analysts at William Blair.
As for CONTACT-02, the trial enrolled 575 patients who received either Cabometyx and Tecentriq or a second novel hormonal therapy. That second therapy was either Astellas and Pfizer’s Xtandi or Johnson & Johnson’s Zytiga. To be eligible for the study, patients had to have measurable soft tissue disease and to have tried one prior hormonal therapy.
Prostate cancer is the second most common cancer in men and the fourth most common cancer globally, according to Exelixis. More than 1.4 million new cases and about 375,300 prostate cancer deaths occurred in 2020, the company said.
“These results represent the first positive phase 3 data of its kind for a tyrosine kinase inhibitor and immunotherapy combination in this indication,” Howard Mayer, executive vice president and head of R&D at Ipsen, said in a statement. “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.”
With Monday’s win, Cabometyx plus Tecentriq may have found its footing after a tough run through the clinic.
In March, the combo failed to further stave off cancer progression or death versus Cabometyx alone in kidney cancer patients who’d progressed on initial chemotherapy. Prior to that, the combo missed the mark on its primary endpoint in the phase 3 CONTACT-01 study in patients with unmutated non-small cell lung cancer whose disease progressed on or after treatment with an immune checkpoint inhibitor and platinum chemotherapy.
Prior to that, Cabometyx and Tecentriq failed to beat Bayer’s Nexavar at prolonging patients’ lives in previously untreated hepatocellular carcinoma (HCC), which is the most common type of liver cancer.