Calithera estimates the cost savings resulting from the discontinuation of this trial will be $10-15 million.Ĭalithera will hold a webcast today, Friday, November 5 at 8:30 a.m. Calithera has no plans to continue the development of telaglenastat at this time. Food & Drug Administration (FDA) and has voluntarily discontinued the phase 2 study with agreement from members of the KEAPSAKE Steering Committee. The company has communicated these findings to the U.S. No difference in safety profile was seen between the two arms. The available efficacy data at unblinding, including investigator-assessed progression-free survival (PFS), did not demonstrate clinical benefit, and analysis of the data led to the conclusion that there was a very low probability for the study to achieve a positive result. At the time of unblinding on October 27, 2021, there were 40 patients randomized. The phase 2 randomized, placebo-controlled, double-blind KEAPSAKE study was designed to evaluate the safety and anti-tumor activity of telaglenastat plus standard-of-care chemoimmunotherapy as front-line therapy among patients with stage IV non-squamous non-small cell lung cancer (NSCLC) whose tumors have a KEAP1 or NRF2 mutation. In addition, we are continuing the development of our arginase inhibitor CB-280 for the treatment of cystic fibrosis.” Our near-term clinical development plans include leveraging our clinical and biomarker expertise in the KEAP1/NRF2 pathway in the development of our mTORC1/2 inhibitor sapanisertib in squamous non-small cell lung cancer, as well as advancing the development of our SYK inhibitor mivavotinib in specific biomarker-defined populations of diffuse large B-cell lymphoma. “We remain committed to patients with difficult-to-treat cancers and will continue to advance our investigational targeted therapies for biomarker-specific patient populations. We also want to express our sincere gratitude to the patients who participated in the trial and their families, as well as the physicians who served as investigators for the trial and their site staff,” said Susan Molineaux, PhD, chief executive officer of Calithera.

“We are disappointed in this outcome for the KEAPSAKE trial, but it was a well-run study with an interim analysis that gave us an answer to an important clinical question.

Trial of valor release date