On June 7, 2021 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, reported final results from the Phase 2 CANTATA study evaluating the company’s glutaminase inhibitor telaglenastat (CB-839) (Press release, Calithera Biosciences, JUN 7, 2021, View Source [SID1234583641]). The findings were highlighted in an oral presentation at the virtual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The CANTATA trial evaluated the efficacy and safety of telaglenastat in combination with cabozantinib versus placebo with cabozantinib in patients with advanced or metastatic renal cell carcinoma (RCC) who had been treated with one or two prior lines of systemic therapy, including at least one anti-angiogenic therapy or the combination of ipilimumab and nivolumab.
Results announced previously showed that the addition of telaglenastat to cabozantinib did not improve progression-free survival (PFS) in the study population. Median progression-free survival (mPFS) in patients who received telaglenastat and cabozantinib was 9.2 months versus 9.3 months in patients who received placebo and cabozantinib. The frequency and severity of adverse events in the telaglenastat-treated population were comparable to those of cabozantinib alone and remained consistent with known risks of both agents.
Additional subgroup data was shared today (Abstract 4501), including a pre-specified analysis of CANTATA patients who had received prior immunotherapy that demonstrates patients who received the combination of telaglenastat and cabozantinib had a numerically longer mPFS as compared to patients who received placebo plus cabozantinib (11.1 months versus 9.2 months; HR = 0.77; 95% CI: 0.56, 1.06). Overall survival was not mature at the data cutoff date.
"While we were obviously disappointed by the outcome of the CANTATA study for telaglenastat, we are pleased that the study’s findings may contribute to the growing body of knowledge around efficacy outcomes in patients with RCC," said Susan Molineaux, PhD, president and chief executive officer of Calithera, "It also allowed us to learn more about how telaglenastat may interact with immune checkpoint inhibitors. This is important to us because we are continuing the development of telaglenastat in combination with immune checkpoint inhibitors in a biomarker-selected non-small cell lung cancer population, in the KEAPSAKE clinical study".
The data presentation "CANTATA: Primary analysis of a global, randomized, placebo (Pbo)-controlled, double-blind trial of telaglenastat (CB-839) + cabozantinib versus Pbo + cabozantinib in patients (pts) with advanced/metastatic renal cell carcinoma (mRCC) that progressed on immune checkpoint inhibitor (ICI) or anti-angiogenic therapies" was led by Nizar M. Tannir, MD, FACP, Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Ransom Horne, Jr. Professor for Cancer Research, as part of the virtual "Genitourinary Cancer — Kidney and Bladder" oral session.