- Calithera Biosciences (NASDAQ:CALA) reports positive results from its Phase 2 ENTRATA study of telaglenastat (CB-839) in combination with everolimus in patients with advanced renal cell carcinoma (RCC).
- The combination doubled the median progression-free survival (PFS) in heavily pre-treated patients to 3.8 months as compared to 1.9 months for everolimus alone and reduced the risk of disease progression or death by 36%. It also had a well-tolerated safety profile.
- The primary endpoint of the trial was PFS per investigator assessment with a predetermined threshold of p≤0.2 one-sided. The secondary endpoint of overall survival is not yet mature.
- Telaglenastat is the first glutaminase inhibitor to demonstrate clinical activity for the treatment of cancer.
- Shares are up 13% premarket.