–KEAPSAKE interim analysis demonstrated lack of clinical benefit among patients treated with telaglenastat

–Company will focus on advancing newly acquired targeted oncology compounds sapanisertib and mivavotinib, as well as the ongoing trial of CB-280 for the treatment of cystic fibrosis

SOUTH SAN FRANCISCO, CA, USA I November 05, 2021 I Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision oncology biopharmaceutical company, announced today the decision to terminate its phase 2 KEAPSAKE clinical trial based on a lack of clinical benefit observed in patients treated with telaglenastat in an interim analysis.

“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. 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 remain committed to patients with difficult-to-treat cancers and will continue to advance our investigational targeted therapies for biomarker-specific patient populations. 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. In addition, we are continuing the development of our arginase inhibitor CB-280 for the treatment of cystic fibrosis.”

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. At the time of unblinding on October 27, 2021, there were 40 patients randomized. 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. No difference in safety profile was seen between the two arms. The company has communicated these findings to the U.S. Food & Drug Administration (FDA) and has voluntarily discontinued the phase 2 study with agreement from members of the KEAPSAKE Steering Committee. Calithera has no plans to continue the development of telaglenastat at this time. Calithera estimates the cost savings resulting from the discontinuation of this trial will be $10-15 million.

About Calithera

Calithera Biosciences is a clinical-stage, precision oncology biopharmaceutical company developing targeted therapies to redefine treatment for biomarker-specific patient populations. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer and other life-threatening diseases, Calithera is advancing a robust pipeline of investigational, small molecule oncology compounds with a biomarker-driven approach that targets genetic vulnerabilities in cancer cells to deliver new therapies for patients suffering from aggressive hematologic and solid tumor cancers for which there are currently limited treatment options. Calithera is headquartered in South San Francisco, California. For more information about Calithera, please visit www.calithera.com.

SOURCE: Calithera Biosciences