- KEAPSAKE is a planned Phase 2 randomized trial exploring telaglenastat with standard of care in first-line treatment of patients with lung cancer with KEAP1/NRF2 mutations
SOUTH SAN FRANCISCO, Calif. — Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage biotechnology company focused on discovering and developing novel small-molecule drugs for the treatment of cancer and other life-threatening diseases, today announced that an abstract describing a Phase 2 study of telaglenastat, the company’s glutaminase inhibitor, will be presented today at the American Society of Clinical Oncology 2020 (ASCO20) Virtual Annual Meeting.
The KEAPSAKE study (NCT04265534) will explore telaglenastat versus placebo in combination with a standard-of-care regimen of immunotherapy and chemotherapy as first-line treatment for patients with non-small cell lung cancers (NSCLC) with KEAP1/NRF2 mutations. These mutations, which occur in an estimated 20 percent of NSCLC patients, are associated with aggressive tumor growth and poor outcomes to standard-of-care therapy. The ASCO20 poster describes the study design of the Phase 2 KEAPSAKE trial, which is expected to begin enrollment in the third quarter of 2020. In addition, the poster summarizes the clinical outcomes from a retrospective review of NSCLC patients who were enrolled in a prior Phase 1/2 clinical trial, including a subset of patients with a KEAP1 mutation. These patients were progressing on a checkpoint inhibitor at study entry and were treated with telaglenastat plus nivolumab (NCT02771626).
“We are very motivated to prioritize and initiate the KEAPSAKE study given the clear mechanistic rationale, strong preclinical data, and high unmet medical need in the NSCLC population,” said Susan Molineaux, PhD, president and chief executive officer of Calithera. “The availability of a new front-line therapy that meaningfully improves outcomes would be transformative for patients with NSCLC and a NRF2/KEAP1 mutation.”