Calithera Biosciences to Present Telaglenastat KEAPSAKE Trial in Progress Poster at the IASLC 2021 World Conference on Lung Cancer

Rhea-AI Summary

Calithera Biosciences announced the KEAPSAKE Phase 2 trial evaluating telaglenastat in combination with chemotherapy for patients with non-small cell lung cancer (NSCLC) and KEAP1/NRF2 mutations. The trial will enroll around 120 patients and aims to demonstrate improved progression-free survival. The trial's interim data will be shared in the fourth quarter of 2021 at the IASLC 2021 World Conference on Lung Cancer. This investigational drug is designed to inhibit glutamine consumption in tumors, showing promise for NSCLC treatment.

KEAPSAKE is a Phase 2 randomized trial evaluating telaglenastat with chemoimmunotherapy in front-line among patients with non-small cell lung cancer and a mutation in the KEAP1/NRF2 pathway

SOUTH SAN FRANCISCO, Calif., Sept. 08, 2021 (GLOBE NEWSWIRE) -- 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 it will present a trial in progress poster of the Phase 2 study of telaglenastat at the International Association for the Study of Lung Cancer (IASLC) 2021 World Conference on Lung Cancer.

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 Susan Molineaux, PhD, president and chief executive officer of Calithera. “We look forward to reporting interim data from KEAPSAKE in the fourth quarter.”

Title: KEAPSAKE Study of Telaglenastat vs Placebo Plus Standard-of-Care in 1L KEAP1/NRF2-Mutated Non-squamous Metastatic NSCLC
Abstract: TPS9627
Poster Session: Novel Therapeutics and Targeted Therapies - Clinical Trial in Progress
Poster: P47.07
Date: September 8, 2021
Authors: First Author: David R. Spigel, Wallace Akerley, Makenzi Evangelist, Melissa Johnson, Benjamin Levy, Taofeek Owonikoko, Paul Paik, Thales Papagiannakopoulos, Karen L. Reckamp, Lalith Akella, Sacha Holland, Yonchu Jenkins, Emil Kuriakose, Naiyer Rizvi

A copy of the poster will be available at www.calithera.com in the publications section.

About Telaglenastat

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.

About Calithera

Calithera Biosciences is a clinical-stage biopharmaceutical company pioneering the discovery and development of targeted therapies that disrupt cellular metabolic pathways to preferentially starve tumor cells and enhance immune-cell activity. 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 pipeline of first-in-clinic, oral therapeutics to meaningfully expand treatment options available to patients. Calithera is headquartered in South San Francisco, California. For more information about Calithera, please visit www.calithera.com.

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 Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

SOURCE: Calithera Biosciences, Incorporated

CONTACTS:

Stephanie Wong
Chief Financial Officer
650.870.1063
ir@Calithera.com

INVESTORS:
Burns McClellan
Lee Roth
212.213.0006
lroth@burnsmc.com

FAQ

What is the KEAPSAKE trial about?

The KEAPSAKE trial is a Phase 2 study evaluating telaglenastat alongside chemotherapy in patients with non-small cell lung cancer harboring KEAP1/NRF2 mutations.

When will the interim data from the KEAPSAKE trial be reported?

The interim data from the KEAPSAKE trial is expected to be reported in the fourth quarter of 2021.

How many patients are being enrolled in the KEAPSAKE trial?

The KEAPSAKE trial is enrolling approximately 120 patients with stage IV non-squamous non-small cell lung cancer.

What is the primary endpoint of the KEAPSAKE trial?

The primary endpoint of the KEAPSAKE trial is progression-free survival (PFS).

What is telaglenastat's mechanism of action?

Telaglenastat is a first-in-class glutaminase inhibitor designed to block glutamine consumption in tumor cells.