The trial in progress poster presentation will summarize the ongoing double-blind KEAPSAKE trial (NCT04265534). KEAPSAKE is enrolling approximately 120 patients with stage IV non-squamous NSCLC with tumors that have a KEAP1 or NRF2 mutation. Patients are randomized to receive telaglenastat or placebo, in combination with pembrolizumab, carboplatin and pemetrexed. The primary endpoint of the study is progression-free survival (PFS).
“We believe in the potential of telaglenastat to meaningfully improve outcomes for patients with NSCLC harboring KEAP1/NRF2 mutations.” said
Title: KEAPSAKE Study of Telaglenastat vs Placebo Plus Standard-of-Care in 1L KEAP1/NRF2-Mutated Non-squamous Metastatic NSCLC
Poster Session: Novel Therapeutics and Targeted Therapies - Clinical Trial in Progress
Authors: First Author:
A copy of the poster will be available at www.calithera.com in the publications section.
Telaglenastat (CB-839) is an investigational, first-in-class, novel glutaminase inhibitor specifically designed to block glutamine consumption in tumor cells. While normal cells use glucose to meet cellular energy demands, tumor cells have a unique oncometabolism that increases their dependence on glutamine to fuel growth and survival. Calithera is conducting the randomized Phase 2 KEAPSAKE trial to evaluate telaglenastat in patients with advanced non-small cell lung cancer harboring KEAP1/NRF2 mutations.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," "poised" and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to Calithera’s clinical trials, the anticipated timing of the presentation of interim data from the randomized trial in NSCLC patients with genetic mutations KEAP1/NRF2, and the potential impact of telaglenastat for patients with NSCLC and a NRF2/KEAP1 mutation. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The potential product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or be successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera’s stock price. Additional information concerning these and other risk factors affecting Calithera’s business can be found in Calithera’s periodic filings with the
SOURCE: Calithera Biosciences, Incorporated
Chief Financial Officer
Source: Calithera Biosciences, Inc.