Phase 2 Study of Novel Drug and Cabometyx Combo in Advanced or Metastatic Kidney Cancer Fails to Meet its Main Goal of Improving Progression-Free Survival

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Patients with advanced or metastatic kidney cancer treated with the novel drug combination achieved a median progression-free survival of 9.2 months compared to 9.3 months among patients who received Cabometyx with a placebo.

Compared to treatment with Cabometyx (cabozantinib) alone, the addition of the investigational novel glutaminase inhibitor CB-839 (telaglenastat) to Cabometyx failed to meet the phase 2 CANTATA trial’s main goal of improving progression-free survival, or the time from the start of treatment until disease worsened, in the treatment of patients with advanced of metastatic renal cell carcinoma (RCC), according to a press release from Calithera Biosciences, CB-839’s manufacturer.

“We are disappointed that the CANTATA trial did not achieve its primary endpoint, particularly on behalf of the people living with advanced RCC, many of whom could benefit from additional treatment options with novel mechanisms of action to address this difficult-to-treat disease,” Calithera’s president and CEO Susan Molineaux said in a company-issued press release.

The global, randomized, double-blind study assessed the safety and efficacy of CB-839 in combination with Cabometyx compared to a placebo plus Cabometyx in patients with advanced or metastatic RCC who had received one or two previous lines of systemic therapy.

Patients treated with the CB-839 combination achieved a median PFS of 9.2 months compared to 9.3 months among patients who received Cabometyx with a placebo. Side effect frequency and severity were similar between the two treatment arms.

Calithera is expected to submit the results of the CANTATA trial for presentation at an upcoming medical conference.

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