Initial Results from Phase 2 Study of CB-839 in Combination with Opdivo® (nivolumab) to be Presented at the Society for Immu...
November 07 2017 - 8:01AM
Achieved confirmed responses in melanoma patients
progressing on PD-1/PD-L1 therapy
Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage
pharmaceutical company focused on discovering and developing novel
small molecule drugs directed against tumor metabolism and tumor
immunology targets for the treatment of cancer today announced that
initial data from the ongoing trial of CB-839 in combination with
Opdivo® in patients with melanoma, renal cell carcinoma and
non-small cell lung cancer will be presented Saturday, November
11th, 2017, at the Society for Immunotherapy of Cancer (SITC)
Annual Meeting. Calithera also announced it has expanded its
existing clinical collaboration with Bristol-Myers Squibb,
evaluating CB-839 in combination with Opdivo®. CB-839 is an
orally bioavailable glutaminase inhibitor currently in Phase 2
trials, and Opdivo® is a PD-1 immune checkpoint inhibitor designed
to overcome immune suppression.
"This trial is designed to include patients who are currently
receiving checkpoint inhibitor therapy and experiencing disease
progression at the time of enrollment. There is significant
unmet need among these patients, and the responses observed would
not be expected with treatment with Opdivo® alone in this
population," said Susan M. Molineaux, Ph.D., founder, Chief
Executive Officer and President of Calithera Biosciences.
"The expanded clinical collaboration with Bristol-Myers Squibb will
help us pursue our strategy of developing CB-839 in combination
with Opdivo® with the hope of improving treatment options for
patients with
cancer.”
Calithera is conducting a Phase 1/2 trial (NCT02771626) in
collaboration with Bristol-Myers Squibb designed to evaluate the
safety, tolerability and efficacy of CB-839 in combination with
Opdivo® in patients with renal cell carcinoma, melanoma or
non-small cell lung cancer. The study will be expanded to
enroll additional melanoma patients. As part of the expanded
collaboration, melanoma development costs will be shared, and a
joint development committee will be established to guide the
development and regulatory strategy.
The ongoing study enrolled three cohorts of patients who have
received a checkpoint inhibitor (PD-1/PD-L1) in the most recent
line of therapy.
- Among 16 evaluable melanoma patients, all of whom were
progressing on a checkpoint inhibitor at study entry, one patient
achieved a complete response and two patients achieved partial
responses. The overall response rate in this cohort was 19%,
and the overall disease control rate was 44%.
- Among six evaluable non-small cell lung cancer patients, all of
whom were progressing on a checkpoint inhibitor at study entry, 67%
experienced stable disease.
- Among eight evaluable renal cell carcinoma patients, 75% were
progressing and 25% had stable disease at study entry. Stable
disease was achieved in 75%, all of whom were progressing on a
checkpoint inhibitor at study entry.
The study enrolled one cohort of renal cell
carcinoma patients who have received a checkpoint inhibitor in any
prior line of therapy, but never achieved a response to checkpoint
therapy.
- Among seven evaluable checkpoint inhibitor experienced renal
cell carcinoma patients, with a median of four prior lines of
therapy, 57% experienced stable disease.
The study enrolled one cohort of renal cell
carcinoma patients who were previously treated with VEGF inhibiting
therapy, and were naïve to checkpoint inhibitors.
- Among 19 evaluable checkpoint inhibitor naïve renal cell
carcinoma patients, four patients (21%) achieved a partial response
and disease control rate was 74%. Fifty percent of the
enrolled patients remain on study treatment.
An analysis of all safety evaluable patients demonstrated that
CB-839 was well tolerated when combined with Opdivo® in melanoma,
renal cell carcinoma and non-small cell lung cancer patients.
During dose escalation of the combination therapy, there was one
report of dose limiting Grade 3 ALT increase, however no maximum
tolerated dose was reported. The majority of adverse events
reported have been mild to moderate with the most common being
fatigue, nausea and photophobia. With 3.7% immune-related
adverse events Grade ≥ 3, the data suggest there was no apparent
increase in the rate or severity of immune related events compared
to historical rates.
Dr. Funda Meric-Bernstam from MD Anderson Cancer Center will
present the results on Saturday, November 11, 2017, in an oral and
poster session (Abstract #O16), “A phase 1/2 study of CB-839, a
first-in-class glutaminase inhibitor, combined with nivolumab in
patients with advanced melanoma, renal cell carcinoma or non-small
cell lung cancer.” The oral presentation slides and the
poster will be available on the Company's website in the
publication section at https://www.calithera.com/publications.
Calithera will webcast a clinical update on CB-839 on Saturday,
November 11th at 3:30 p.m. Pacific Time/ 6:30 p.m. Eastern
Time. The call can be accessed by dialing (855) 783-2599
(domestic) or (631) 485-4877 (international), and referring to
conference ID 1878409. 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 CB-839Calithera’s lead product candidate,
CB-839, is a potent, selective, reversible and orally bioavailable
inhibitor of glutaminase. CB-839’s onco-metabolism activity
takes advantage of the unique metabolic requirements of tumor cells
and cancer-fighting immune cells such as cytotoxic T-cells. It is
currently being evaluated in Phase 2 clinical trials in multiple
tumor types, in combination with standard of care agents.
About CalitheraCalithera is a clinical-stage
biopharmaceutical company focused on fighting cancer by
discovering, developing, and commercializing novel small molecule
drugs that target tumor and immune cell metabolism. Calithera is
headquartered in South San Francisco, California. For more
information about Calithera, please visit www.calithera.com.
Forward Looking StatementsStatements 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 safety,
tolerability and efficacy of CB-839, Calithera’s plans to continue
development of CB-839 in combination therapy for clear cell renal
cell carcinoma, the potential for combining nivolumab (marketed as
Opdivo®) with CB-839 to drive improved and sustained efficacy in
clear cell renal cell carcinoma and other cancers, including NSCLC
and melanoma, and the advancement of CB-839 in clinical
trials. 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 Annual Report on
Form 10-K 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.
Contact:Jennifer
McNealeyir@Calithera.com 650-870-1071
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