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, presented today supporting data for its
previously reported positive results from its randomized
placebo-controlled Phase 2 ENTRATA study of telaglenastat (CB-839)
in combination with everolimus in patients with advanced renal cell
carcinoma (RCC). The telaglenastat-everolimus combination doubled
the median progression-free survival (PFS) in heavily pre-treated
patients with advanced RCC and had a well-tolerated safety profile.
Telaglenastat is the first glutaminase inhibitor to demonstrate
clinical activity for the treatment of cancer.
Calithera announced top-line results from the ENTRATA trial in
June. Data from the study were accepted as a late-breaker abstract
and will be shared for the first time this morning during an oral
presentation at the European Society for Medical Oncology (ESMO)
Congress 2019 in Barcelona, Spain (#LBA54).
“Outcomes for late-line metastatic renal cell carcinoma are
often poor using currently available medications with similar
mechanism of action,” said Chung-Han Lee, MD, PhD, Memorial Sloan
Kettering Cancer Center, who will present the data. “New
treatments with novel mechanisms of action are greatly needed for
this patient population. The results from the randomized ENTRATA
trial demonstrate activity of telaglenastat in RCC and provide
proof of concept for glutaminase inhibition as a new mechanism of
action that may improve outcomes for patients with this
disease.”
“We continue to be encouraged by these data, which suggest that
glutaminase inhibition – and telaglenastat in particular - could
offer advanced RCC patients a novel therapeutic option,” said Susan
Molineaux, PhD, president and chief executive officer of Calithera.
“ENTRATA demonstrates a clinically meaningful improvement in
progression-free survival among patients with advanced disease who
have been treated with many prior lines of therapy. We are
evaluating telaglenastat in the ongoing CANTATA trial in
combination with cabozantinib for patients with advanced clear cell
RCC, and we look forward to learning how telaglenastat performs in
this setting.”
Key demographics in patients enrolled in the phase 2 ENTRATA
study were balanced between the two treatment arms (telaglenastat
in combination with everolimus versus placebo with everolimus) and
were heavily pre-treated, with a median of three prior lines of
therapy for advanced metastatic disease including 70% (72% vs. 65%)
with two or more prior tyrosine kinase inhibitors (TKI), and 68%
(70% vs. 65%) with intermediate/poor MSKCC prognostic score.
Eighty-eight percent of patients received prior PD-1/PD-L1 therapy
(91% vs. 83%).
When added to everolimus, telaglenastat doubled the median PFS
to 3.8 months as compared to 1.9 months for everolimus alone and
reduced the risk of disease progression or death by 36% (HR=0.64,
p=0.079 one-sided). The primary endpoint of the trial was PFS per
investigator assessment with a predetermined threshold of p≤0.2
one-sided. Overall response per Response Evaluation Criteria in
Solid Tumors version 1.1 (RECIST v.1.1) was 2.2% vs. 0%, and stable
disease was 56.5% vs. 47.8%. The secondary endpoint of overall
survival is not yet mature.
Frequency of all-grade adverse events in the
telaglenastat-containing arm were comparable to that of everolimus
alone. Grade 3 or higher adverse events occurred in 80.4% of
patients in the telaglenastat plus everolimus arm versus 60.9% in
the everolimus plus placebo arm. The most frequently reported Grade
≥3 adverse events in the treatment versus control arms,
respectively, were anemia (17.4% vs. 17.4%), pneumonia (6.5% vs.
4.3%), abdominal pain (6.5% vs. 0%), thrombocytopenia (6.5% vs.
0%), and fatigue (4.3% vs. 8.7%). Adverse events leading to
discontinuation of any study drug were comparable (28.3% vs.
30.4%).
The ENTRATA trial (NCT03163667) is a randomized, double-blind
Phase 2 trial designed to evaluate the efficacy and safety of
telaglenastat in combination with everolimus versus placebo with
everolimus in patients with advanced clear cell RCC who have been
treated with at least two prior lines of systemic therapy,
including at least one VEGFR-targeted TKI. Patients were randomized
in a 2:1 ratio, and stratified by prior TKI treatment and MSKCC
prognostic score. The trial enrolled 69 patients at multiple
centers in the United States.
Telaglenastat is an investigational first-in-class glutaminase
inhibitor specifically designed to block glutamine consumption in
tumor cells. RCC tumors commonly exhibit metabolic
alterations that increase their dependence on glutamine. In
preclinical studies, telaglenastat produced synergistic antitumor
effects when used in combination with standard-of-care RCC
therapies.
Telaglenastat is also being investigated in the CANTATA trial
(NCT03428217), a global, randomized, double-blind trial designed to
evaluate the efficacy and safety of telaglenastat in combination
with cabozantinib versus placebo with cabozantinib in patients with
advanced or metastatic RCC who have been treated with one or two
prior lines of systemic therapy including at least one vascular
endothelial growth factor tyrosine kinase inhibitor or the
combination of nivolumab and ipilimumab. In April 2018, the U.S.
Food and Drug Administration granted Fast Track designation to
telaglenastat in this indication. The primary endpoint is
progression-free survival by blinded independent review, and a key
secondary endpoint is overall survival. Calithera plans to report
top-line efficacy and safety data from the trial in the second half
of 2020.
A link to a copy of the presentation is available on Calithera’s
corporate website at
https://www.calithera.com/publications-and-presentations.
Conference Call Information
Calithera will host an update conference call Monday, September
30, at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time. The call
may be accessed by dialing (855) 783-2599 (domestic) or (631)
485-4877 and referring to conference ID 1469186. To access the live
audio webcast or the subsequent archived recording, visit the
Investors section of the Calithera website at www.calithera.com.
The webcast will be recorded and available for replay on
Calithera’s website for 30 days.
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 block tumor cell growth 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 the potential
for telaglenastat to be developed in combination with therapeutics,
such as everolimus or cabozantinib, to improve patient outcomes,
safety, tolerability and efficacy of telaglenastat; the overall
advancement and timing of telaglenastat in clinical trials; and the
unmet need in the treatment of patients with advanced RCC. 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 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 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 most recent
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission, and other 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, Inc.
INVESTOR CONTACT: Jennifer McNealey
ir@Calithera.com650-870-1071
MEDIA CONTACT: Hannah Hurdle
hannahhurdle@sambrown.com 805-338-4752
Calithera Biosciences (NASDAQ:CALA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Calithera Biosciences (NASDAQ:CALA)
Historical Stock Chart
From Apr 2023 to Apr 2024