- Calithera Biosciences Inc CALA has decided to terminate its phase 2 KEAPSAKE trial based on a lack of clinical benefit observed in patients treated with telaglenastat in an interim analysis.
- The Phase 2 KEAPSAKE study was designed to evaluate the safety and anti-tumor activity of telaglenastat plus standard-of-care chemo-immunotherapy as front-line therapy for stage IV non-squamous non-small cell lung cancer (NSCLC) harboring KEAP1 or NRF2 mutation.
- At the time of unblinding on October 27, there were 40 patients randomized.
- The available efficacy data did not demonstrate clinical benefit, and analysis of the data concluded that there was a very low probability for the study to achieve a positive result.
- No difference in safety profile was seen between the two arms.
- Calithera estimates the cost savings resulting from the discontinuation of this trial will be $10-15 million.
- Related: Calithera Buys Two Oncology Candidates From Takeda For $45M.
- Price Action: CALA shares are down 43.70% at $1.07 during the premarket session on the last check Friday.
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