Phase 3 Cabometyx Study in Patients with Kidney Cancer Fails to Meet Goal

The phase 3 CONTACT-03 study evaluating Cabometyx (cabozantinib) plus Tecentriq (atezolizumab) in patients with locally advanced or metastatic clear cell or non-clear cell renal cell carcinoma, types of kidney cancer, did not meet its primary endpoint, according to a press release from Elixis, the drugs manufacturer.

In particular, the primary endpoint was progression-free survival, or time during and after treatment when the patient lives without disease progression.

The trial included 522 patients with kidney cancer who progressed during or after immune checkpoint inhibitor therapy. Patients were randomized to receive either their experimental combination of Cabometyx and Tecentriq or Cabometyx alone. Secondary endpoints of the trial included objective response rate (the rate of a measurable response to the treatment) and duration of response (the time the disease responds to a treatment without growth or spread).

“There is limited data available to suggest the optimal treatment for these patients and CONTACT-03 was initiated in the hope of defining the clinical benefit of the combination of a multi-tyrosine kinase inhibitor and an immune checkpoint inhibitor following progression,” the release reported.

Of note, the safety profile of the experimental combination was consistent with what has previously been reported on the single agent, and no new signals were observed.

Further detailed findings will be reported at an upcoming medical meeting.

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