Calithera Achieves Positive Topline Results in Randomized Phase 2 ENTRATA Study of Telaglenastat with Everolimus in Renal Cel...
June 17 2019 - 6:00AM
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 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 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.
“The achievement of positive topline results in our first
randomized trial is a significant milestone for Calithera because
it provides clinical proof of concept for telaglenastat,” said
Susan Molineaux, PhD, president and chief executive officer of
Calithera. “This study demonstrates a clinically meaningful
improvement in progression free survival in patients with advanced
renal cell carcinoma who have been treated with many prior lines of
therapy, including immunotherapy and multiple tyrosine kinase
inhibitors. We look forward to the outcome of the ongoing CANTATA
trial of telaglenastat in combination with cabozantinib for
patients with advanced clear cell RCC.”
Patients enrolled were heavily pre-treated with a median of
three prior lines of therapy for advanced metastatic disease
including 70% with two or more prior tyrosine kinase inhibitors
(TKI), and 68% with intermediate/poor MSKCC prognostic score.
Eighty-eight percent of patients received prior PD-1/PD-L1 therapy.
Telaglenastat, when added to everolimus, 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. 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 stratified
by prior TKI treatment and MSKCC prognostic score. The trial
enrolled 69 patients at multiple centers in the United States.
Calithera intends to present data at an upcoming medical
meeting.
Telaglenastat is an investigational, novel glutaminase inhibitor
specifically designed to block glutamine consumption in tumor
cells. RCC tumors commonly exhibit specific genetic
alterations that cause cancer cells to increase metabolism of
glutamine. In preclinical studies, telaglenastat produced
synergistic antitumor effects when used in combination with
standard-of-care RCC therapies, including everolimus and
cabozantinib.
Telaglenastat is also being investigated in the CANTATA trial, a
global, randomized, double-blind Phase 2 trial designed to evaluate
the efficacy and safety of telaglenastat in combination with
cabozantinib versus placebo with cabozantinib in patients with
advanced clear cell RCC who have been treated with one or two prior
lines of systemic therapy. CANTATA will enroll approximately 400
patients and is designed with registrational intent. The primary
endpoint is PFS by blinded independent review. Calithera expects
data from this trial in the second half of 2020.
Conference Call Information
Calithera will host an update conference call today, Monday,
June 17, 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 6492963. 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.com 650-870-1071
MEDIA CONTACT: Hannah Hurdle
hannahhurdle@sambrown.com 805-338-4752
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