Calithera, which develops novel small molecule therapies for cancer and other life-threatening diseases, announced positive top-line results from a Phase 2 study dubbed ENTRATA that is evaluating telaglenastat, or CB-839, in combination with the chemotherapy drug everolimus in patients with renal cell carcinoma.
Telaglenastat is the first glutaminase inhibitor to demonstrate clinical activity for treating cancer.
The enrolled patients were heavily pre-treated with a median of three prior lines of therapy for advanced metastatic disease, including immunotherapy and multiple tyrosine kinase inhibitors.
The enrollees demonstrated that the evaluated combo treatment doubled the median progress-free survival to 3.8 months compared to 1.9 months for everolimus alone, Calithera said.
The risk of disease progression or death was also reduced by 36% in the combo treatment arm.
The combination was well-tolerated.
The secondary endpoint of overall survival has yet to mature, according to the South San Francisco, California-based biotech.
Why It's Important
Telaglenastat is Calithera's lead product candidate and is being evaluated in several combinations for renal cell carcinoma as well as solid tumors.
Two separate trials for renal cell carcinoma in combination with the chemotherapy drug cabozantinib and with everolimus are in the most advanced stage of clinical development among its pipeline assets.
"The achievement of positive topline results in our first randomized trial is a significant milestone for Calithera because it provides clinical proof of concept for teleglenastat," Calithera CEO Susan Molineaux said in a statement.
Calithera shares were up 3.84% at $5.41 at the time of publication Monday.
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