- Study to evaluate potential of
CB-839 plus Opdivo to target immunosuppressive cancer metabolism in
the tumor microenvironment
- Companies have ongoing collaboration
evaluating clear cell renal cell carcinoma
Bristol-Myers Squibb Company (NYSE:BMY) and Calithera
Biosciences, Inc. (Nasdaq:CALA), a clinical-stage biotechnology
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 the companies
have expanded their existing collaboration to evaluate
Bristol-Myers Squibb’s Opdivo in combination with Calithera’s
CB-839 in patients with non-small cell lung cancer (NSCLC) and
melanoma. CB-839 is an investigational orally administered
glutaminase inhibitor currently in Phase 1/2 clinical studies.
Preclinical data suggest that CB-839, which is designed to
target a pathway to starve tumor cells of the key nutrient
glutamine, may enhance the effects of checkpoint inhibitors and may
also reverse tumor resistance to checkpoint inhibitors by altering
the immune-suppressive microenvironment and promoting an anti-tumor
immune response. Opdivo is designed to overcome immune
suppression. The companies will evaluate the potential clinical
value of combining these two agents to treat NSCLC and
melanoma.
“We are pleased to expand our collaboration with Calithera into
NSCLC and melanoma, building upon our existing clinical study
evaluating Opdivo and CB-839 in clear cell renal cell carcinoma,”
said Fouad Namouni, M.D., senior vice president, Head of Oncology
Development, Bristol-Myers Squibb.
“The expansion of this clinical collaboration with Bristol-Myers
Squibb into NSCLC and melanoma is an important addition to our
immunotherapy clinical strategy for CB-839,” said Susan Molineaux,
CEO of Calithera Biosciences. “This represents one of several
strategies to develop CB-839, a glutaminase inhibitor, in
combination with approved therapies with the hope of improving the
treatment of patients with solid tumors.”
About Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint
inhibitor that is designed to uniquely harness the body’s own
immune system to help restore anti-tumor immune response. By
harnessing the body’s own immune system to fight
cancer, Opdivo has become an important treatment option
across multiple cancers.
Opdivo’s leading global development program is based on
Bristol-Myers Squibb’s scientific expertise in the field of
Immuno-Oncology and includes a broad range of clinical trials
across all phases, including Phase 3, in a variety of tumor types.
To date, the Opdivo clinical development program has
enrolled more than 25,000 patients. The Opdivo trials
have contributed to gaining a deeper understanding of the potential
role of biomarkers in patient care, particularly regarding how
patients may benefit from Opdivo across the continuum of
PD-L1 expression.
In July 2014, Opdivo was the first PD-1 immune
checkpoint inhibitor to receive regulatory approval anywhere in the
world. Opdivo is currently approved in more than 60
countries, including the United States, the European Union and
Japan. In October 2015, the
company’s Opdivo and Yervoy combination regimen was
the first Immuno-Oncology combination to receive regulatory
approval for the treatment of metastatic melanoma and is currently
approved in more than 50 countries, including the United States and
the European Union.
INDICATIONS
OPDIVO® (nivolumab) as a single agent is indicated for the
treatment of patients with BRAF V600 mutation-positive unresectable
or metastatic melanoma. This indication is approved under
accelerated approval based on progression-free survival. Continued
approval for this indication may be contingent upon verification
and description of clinical benefit in the confirmatory trials
OPDIVO® (nivolumab) as a single agent is indicated for the
treatment of patients with BRAF V600 wild-type unresectable or
metastatic melanoma.
OPDIVO® (nivolumab), in combination with
YERVOY® (ipilimumab), is indicated for the treatment of
patients with unresectable or metastatic melanoma. This indication
is approved under accelerated approval based on progression-free
survival. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in the
confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients
with metastatic non-small cell lung cancer (NSCLC) with progression
on or after platinum-based chemotherapy. Patients with EGFR or ALK
genomic tumor aberrations should have disease progression on
FDA-approved therapy for these aberrations prior to receiving
OPDIVO.
OPDIVO® (nivolumab) is indicated for the treatment of patients
with advanced renal cell carcinoma (RCC) who have received prior
anti-angiogenic therapy.
OPDIVO® (nivolumab) is indicated for the treatment
of adult patients with classical Hodgkin lymphoma (cHL)
that has relapsed or progressed after autologous hematopoietic
stem cell transplantation (HSCT)
and brentuximab vedotin or after 3 or more lines of
systemic therapy that includes autologous HSCT. This indication is
approved under accelerated approval based on overall response rate.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in confirmatory
trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients
with recurrent or metastatic squamous cell carcinoma of the head
and neck (SCCHN) with disease progression on or after
platinum-based therapy.
OPDIVO® (nivolumab) is indicated for the treatment of patients
with locally advanced or metastatic urothelial carcinoma who have
disease progression during or following platinum-containing
chemotherapy or have disease progression within 12 months of
neoadjuvant or adjuvant treatment with platinum-containing
chemotherapy. This indication is approved under accelerated
approval based on tumor response rate and duration of response.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in confirmatory
trials.
IMPORTANT SAFETY
INFORMATION
WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS
YERVOY can result in severe and fatal immune-mediated adverse
reactions. These immune-mediated reactions may involve any organ
system; however, the most common severe immune-mediated adverse
reactions are enterocolitis, hepatitis, dermatitis (including toxic
epidermal necrolysis), neuropathy, and endocrinopathy. The majority
of these immune-mediated reactions initially manifested during
treatment; however, a minority occurred weeks to months after
discontinuation of YERVOY.
Assess patients for signs and symptoms of enterocolitis,
dermatitis, neuropathy, and endocrinopathy and evaluate clinical
chemistries including liver function tests (LFTs),
adrenocorticotropic hormone (ACTH) level, and thyroid function
tests at baseline and before each dose.
Permanently discontinue YERVOY and initiate systemic
high-dose corticosteroid therapy for severe immune-mediated
reactions.
Immune-Mediated Pneumonitis
OPDIVO can cause immune-mediated pneumonitis. Fatal cases have
been reported. Monitor patients for signs with radiographic
imaging and for symptoms of pneumonitis. Administer corticosteroids
for Grade 2 or more severe pneumonitis. Permanently
discontinue for Grade 3 or 4 and withhold until resolution for
Grade 2. In patients receiving OPDIVO monotherapy, fatal cases
of immune-mediated pneumonitis have occurred. Immune-mediated
pneumonitis occurred in 3.1% (61/1994) of patients. In
patients receiving OPDIVO with YERVOY, immune-mediated
pneumonitis occurred in 6% (25/407) of patients.
In Checkmate 205 and 039, pneumonitis, including
interstitial lung disease, occurred in 6.0% (16/266) of
patients receiving OPDIVO. Immune-mediated pneumonitis occurred
in 4.9% (13/266) of patients receiving OPDIVO: Grade
3 (n=1) and Grade 2 (n=12).
Immune-Mediated Colitis
OPDIVO can cause immune-mediated colitis. Monitor patients
for signs and symptoms of colitis. Administer corticosteroids
for Grade 2 (of more than 5 days duration), 3, or 4
colitis. Withhold OPDIVO monotherapy for Grade 2 or
3 and permanently discontinue for Grade 4 or recurrent colitis
upon re-initiation of OPDIVO. When administered with
YERVOY, withhold OPDIVO and YERVOY for Grade 2 and
permanently discontinue for Grade 3 or 4 or recurrent
colitis. In patients receiving OPDIVO monotherapy,
immune-mediated colitis occurred in 2.9% (58/1994) of
patients. In patients receiving OPDIVO with YERVOY,
immune-mediated colitis occurred in 26% (107/407) of patients
including three fatal cases.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe,
life-threatening, or fatal (diarrhea of ≥7 stools above baseline,
fever, ileus, peritoneal signs; Grade 3-5) immune-mediated
enterocolitis occurred in 34 (7%) patients. Across all
YERVOY-treated patients in that study (n=511), 5 (1%) developed
intestinal perforation, 4 (0.8%) died as a result of complications,
and 26 (5%) were hospitalized for severe enterocolitis.
Immune-Mediated Hepatitis
OPDIVO can cause immune-mediated hepatitis. Monitor
patients for abnormal liver tests prior to and periodically during
treatment. Administer corticosteroids for Grade 2 or greater
transaminase elevations. Withhold for Grade 2 and permanently
discontinue for Grade 3 or 4 immune-mediated hepatitis. In
patients receiving OPDIVO monotherapy, immune-mediated hepatitis
occurred in 1.8% (35/1994) of patients. In patients receiving
OPDIVO with YERVOY, immune-mediated hepatitis occurred in 13%
(51/407) of patients.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe,
life-threatening, or fatal hepatotoxicity (AST or ALT elevations
>5x the ULN or total bilirubin elevations >3x the ULN; Grade
3-5) occurred in 8 (2%) patients, with fatal hepatic failure
in 0.2% and hospitalization in 0.4%.
Immune-Mediated Neuropathies
In a separate Phase 3 study of YERVOY 3 mg/kg, 1 case of fatal
Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral
motor neuropathy were reported.
Immune-Mediated Endocrinopathies
OPDIVO can cause immune-mediated
hypophysitis, immune-mediated adrenal
insufficiency, autoimmune thyroid disorders, and Type 1
diabetes mellitus. Monitor patients for signs and symptoms of
hypophysitis, signs and symptoms of adrenal insufficiency, thyroid
function prior to and periodically during treatment, and
hyperglycemia. Administer hormone replacement as clinically
indicated and corticosteroids for Grade 2 or greater hypophysitis.
Withhold for Grade 2 or 3 and permanently discontinue for Grade 4
hypophysitis. Administer corticosteroids for Grade 3 or 4
adrenal insufficiency. Withhold for Grade 2 and permanently
discontinue for Grade 3 or 4 adrenal insufficiency. Administer
hormone-replacement therapy for hypothyroidism. Initiate medical
management for control of hyperthyroidism. Withhold OPDIVO for
Grade 3 and permanently discontinue for Grade 4 hyperglycemia.
In patients receiving OPDIVO monotherapy, hypophysitis
occurred in 0.6% (12/1994) of patients. In patients receiving
OPDIVO with YERVOY, hypophysitis occurred in 9% (36/407) of
patients. In patients receiving OPDIVO monotherapy,
adrenal insufficiency occurred in 1% (20/1994) of patients. In
patients receiving OPDIVO with YERVOY, adrenal insufficiency
occurred in 5% (21/407) of patients. In patients receiving
OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in
hypothyroidism occurred in 9% (171/1994) of
patients. Hyperthyroidism occurred in 2.7% (54/1994) of
patients receiving OPDIVO monotherapy. In patients
receiving OPDIVO with YERVOY, hypothyroidism or thyroiditis
resulting in hypothyroidism occurred in 22% (89/407) of
patients. Hyperthyroidism occurred in 8% (34/407) of patients
receiving OPDIVO with YERVOY. In patients receiving
OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of
patients. In patients receiving OPDIVO with YERVOY,
diabetes occurred in 1.5% (6/407) of patients.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe to
life-threatening immune-mediated endocrinopathies (requiring
hospitalization, urgent medical intervention, or interfering with
activities of daily living; Grade 3-4) occurred in 9 (1.8%)
patients. All 9 patients had hypopituitarism, and some had
additional concomitant endocrinopathies such as adrenal
insufficiency, hypogonadism, and hypothyroidism. 6 of the 9
patients were hospitalized for severe endocrinopathies.
Immune-Mediated Nephritis and Renal Dysfunction
OPDIVO can cause immune-mediated nephritis. Monitor
patients for elevated serum creatinine prior to and periodically
during treatment. Administer corticosteroids for Grades 2-4
increased serum creatinine. Withhold OPDIVO for Grade 2 or 3
and permanently discontinue for Grade 4 increased serum
creatinine. In patients receiving
OPDIVO monotherapy, immune-mediated nephritis and renal
dysfunction occurred in 1.2% (23/1994) of patients. In
patients receiving OPDIVO with YERVOY, immune-mediated
nephritis and renal dysfunction occurred in 2.2% (9/407) of
patients.
Immune-Mediated Skin Adverse Reactions and
Dermatitis
OPDIVO can cause immune-mediated rash, including Stevens-Johnson
syndrome (SJS) and toxic epidermal necrolysis (TEN), some
cases with fatal outcome. Administer corticosteroids for Grade
3 or 4 rash. Withhold for Grade 3 and permanently discontinue for
Grade 4 rash. For symptoms or signs of SJS or TEN,
withhold OPDIVO and refer the patient for specialized care for
assessment and treatment; if confirmed, permanently
discontinue. In patients receiving
OPDIVO monotherapy, immune-mediated rash occurred in 9%
(171/1994) of patients. In patients receiving OPDIVO
with YERVOY, immune-mediated rash occurred in 22.6% (92/407)
of patients.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe,
life-threatening, or fatal immune-mediated dermatitis (eg,
Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash
complicated by full thickness dermal ulceration, or necrotic,
bullous, or hemorrhagic manifestations; Grade 3-5) occurred in
13 (2.5%) patients. 1 (0.2%) patient died as a result of toxic
epidermal necrolysis. 1 additional patient required hospitalization
for severe dermatitis.
Immune-Mediated Encephalitis
OPDIVO can cause immune-mediated
encephalitis. Evaluation of patients with neurologic symptoms
may include, but not be limited to, consultation with a
neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO
in patients with new-onset moderate to severe neurologic signs or
symptoms and evaluate to rule out other causes. If other etiologies
are ruled out, administer corticosteroids and permanently
discontinue OPDIVO for immune-mediated encephalitis. In
patients receiving OPDIVO monotherapy, encephalitis occurred
in 0.2% (3/1994) of patients. Fatal limbic encephalitis
occurred in one patient after 7.2 months of exposure despite
discontinuation of OPDIVO and administration of
corticosteroids. Encephalitis occurred in one patient
receiving OPDIVO with YERVOY (0.2%) after 1.7 months of
exposure.
Other Immune-Mediated Adverse Reactions
Based on the severity of adverse reaction, permanently
discontinue or withhold treatment, administer high-dose
corticosteroids, and, if appropriate, initiate hormone-replacement
therapy. Across clinical trials of OPDIVO the following clinically
significant immune-mediated adverse reactions occurred in <1.0%
of patients receiving OPDIVO: uveitis, iritis, pancreatitis, facial
and abducens nerve paresis, demyelination, polymyalgia
rheumatica, autoimmune neuropathy, Guillain-Barré syndrome,
hypopituitarism, systemic inflammatory response syndrome,
gastritis, duodenitis, sarcoidosis, histiocytic necrotizing
lymphadenitis (Kikuchi lymphadenitis), myositis, myocarditis,
rhabdomyolysis, motor dysfunction, vasculitis,
and myasthenic syndrome.
Infusion Reactions
OPDIVO can cause severe infusion reactions, which have been
reported in <1.0% of patients in clinical
trials. Discontinue OPDIVO in patients with Grade 3 or 4
infusion reactions. Interrupt or slow the rate of infusion in
patients with Grade 1 or 2. In patients receiving
OPDIVO monotherapy, infusion-related reactions occurred in
6.4% (127/1994) of patients. In patients receiving
OPDIVO with YERVOY, infusion-related reactions occurred
in 2.5% (10/407) of patients.
Complications of Allogeneic HSCT after OPDIVO
Complications, including fatal events, occurred in patients who
received allogeneic HSCT after OPDIVO. Outcomes were evaluated in
17 patients from Checkmate 205 and 039, who underwent allogeneic
HSCT after discontinuing OPDIVO (15 with reduced-intensity
conditioning, 2 with myeloablative conditioning).
Thirty-five percent (6/17) of patients died from complications of
allogeneic HSCT after OPDIVO. Five deaths occurred in the setting
of severe or refractory GVHD. Grade 3 or higher acute GVHD was
reported in 29% (5/17) of
patients. Hyperacute GVHD was reported in 20% (n=2)
of patients. A steroid-requiring febrile syndrome, without an
identified infectious cause, was reported in 35% (n=6) of patients.
Two cases of encephalitis were reported: Grade 3 (n=1) lymphocytic
encephalitis without an identified infectious cause, and Grade 3
(n=1) suspected viral encephalitis. Hepatic veno-occlusive
disease (VOD) occurred in one patient, who received
reduced-intensity conditioned allogeneic HSCT and died of GVHD
and multi-organ failure. Other cases of hepatic VOD after
reduced-intensity conditioned allogeneic HSCT have also been
reported in patients with lymphoma who received a PD-1 receptor
blocking antibody before transplantation. Cases of
fatal hyperacute GVHD have also been reported. These
complications may occur despite intervening therapy between PD-1
blockade and allogeneic HSCT.
Follow patients closely for early evidence of transplant-related
complications such as hyperacute GVHD, severe (Grade 3 to
4) acute GVHD, steroid-requiring febrile syndrome, hepatic VOD, and
other immune-mediated adverse reactions, and intervene
promptly.
Embryo-Fetal Toxicity
Based on their mechanisms of action, OPDIVO and YERVOY can cause
fetal harm when administered to a pregnant woman. Advise pregnant
women of the potential risk to a fetus. Advise females of
reproductive potential to use effective contraception during
treatment with an OPDIVO- or YERVOY- containing regimen and for at
least 5 months after the last dose of OPDIVO.
Lactation
It is not known whether OPDIVO or YERVOY is present in human
milk. Because many drugs, including antibodies, are excreted in
human milk and because of the potential for serious adverse
reactions in nursing infants from an OPDIVO-containing regimen,
advise women to discontinue breastfeeding during treatment. Advise
women to discontinue nursing during treatment with YERVOY and for 3
months following the final dose.
Serious Adverse Reactions
In Checkmate 037, serious adverse reactions occurred in 41% of
patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions
occurred in 42% of patients receiving OPDIVO . The most
frequent Grade 3 and 4 adverse drug reactions reported in 2% to
<5% of patients receiving OPDIVO were abdominal pain,
hyponatremia, increased aspartate aminotransferase, and increased
lipase. In Checkmate 066, serious adverse reactions
occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4
adverse reactions occurred in 41% of patients receiving OPDIVO. The
most frequent Grade 3 and 4 adverse reactions reported in ≥2% of
patients receiving OPDIVO were
gamma-glutamyltransferase increase (3.9%) and diarrhea
(3.4%). In Checkmate 067, serious adverse reactions (73%
and 37%), adverse reactions leading to permanent discontinuation
(43% and 14%) or to dosing delays (55% and 28%), and Grade 3 or 4
adverse reactions (72% and 44%) all occurred more frequently in the
OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313).
The most frequent (≥10%) serious adverse reactions in the OPDIVO
plus YERVOY arm and the OPDIVO arm, respectively, were
diarrhea (13% and 2.6%), colitis (10% and 1.6%), and pyrexia
(10% and 0.6%). In Checkmate 017 and 057, serious adverse
reactions occurred in 46% of patients receiving OPDIVO (n=418). The
most frequent serious adverse reactions reported in at least 2% of
patients receiving OPDIVO were pneumonia, pulmonary embolism,
dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory
failure. In Checkmate 025, serious adverse reactions occurred
in 47% of patients receiving OPDIVO (n=406). The most frequent
serious adverse reactions reported in ≥2% of patients were acute
kidney injury, pleural effusion, pneumonia, diarrhea, and
hypercalcemia. In Checkmate 205 and 039, adverse reactions
leading to discontinuation occurred in 7% and dose delays due
to adverse reactions occurred in 34% of patients
(n=266). Serious adverse reactions occurred in 26% of
patients. The most frequent serious adverse reactions reported
in ≥1% of patients were pneumonia, infusion-related reaction,
pyrexia, colitis or diarrhea, pleural effusion, pneumonitis,
and rash. Eleven patients died from causes other than
disease progression: 3 from adverse reactions within 30 days
of the last OPDIVO dose, 2 from infection 8 to 9 months after
completing OPDIVO, and 6 from complications of allogeneic
HSCT. In Checkmate 141, serious adverse reactions occurred in 49%
of patients receiving OPDIVO. The most frequent serious adverse
reactions reported in at least 2% of patients receiving OPDIVO
were pneumonia, dyspnea, respiratory failure, respiratory
tract infection, and sepsis. In Checkmate 275, serious adverse
reactions occurred in 54% of patients receiving OPDIVO (n=270). The
most frequent serious adverse reactions reported in at least 2% of
patients receiving OPDIVO were urinary tract infection, sepsis,
diarrhea, small intestine obstruction, and general physical health
deterioration.
Common Adverse Reactions
In Checkmate 037, the most common adverse reaction (≥20%)
reported with OPDIVO (n=268) was rash (21%). In Checkmate 066,
the most common adverse reactions (≥20%) reported with OPDIVO
(n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%),
musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus
(23% vs 12%). In Checkmate 067, the most common (≥20%) adverse
reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (59%),
rash (53%), diarrhea (52%), nausea (40%), pyrexia (37%), vomiting
(28%), and dyspnea (20%). The most common (≥20%) adverse reactions
in the OPDIVO (n=313) arm were fatigue (53%), rash (40%), diarrhea
(31%), and nausea (28%). In Checkmate 017 and 057, the most
common adverse reactions (≥20%) in patients receiving OPDIVO
(n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and
decreased appetite. In Checkmate 025, the most common adverse
reactions (≥20%) reported in patients receiving OPDIVO (n=406)
vs everolimus (n=397) were asthenic conditions (56% vs
57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%),
dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs
18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and
arthralgia (20% vs 14%). In Checkmate 205 and 039, the most
common adverse reactions (≥20%) reported in patients receiving
OPDIVO (n=266) were upper respiratory tract infection
(44%), fatigue (39%), cough (36%), diarrhea
(33%), pyrexia (29%), musculoskeletal pain (26%), rash
(24%), nausea (20%) and pruritus (20%). In Checkmate 141, the most
common adverse reactions (≥10%) in patients receiving OPDIVO were
cough and dyspnea at a higher incidence than investigator’s
choice. In Checkmate 275, the most common adverse reactions (≥
20%) reported in patients receiving OPDIVO (n=270) were fatigue
(46%), musculoskeletal pain (30%), nausea (22%), and decreased
appetite (22%).
In a separate Phase 3 study of YERVOY 3 mg/kg, the most common
adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg
were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and
colitis (8%).
Please see U.S. Full Prescribing Information,
including Boxed WARNING regarding immune-mediated adverse
reactions, for YERVOY.
Please see U.S. Full Prescribing Information for
OPDIVO.
About the Bristol-Myers Squibb and Ono
Pharmaceutical Co., Ltd. Collaboration
In 2011, through a collaboration agreement with Ono
Pharmaceutical Co., Ltd (Ono), Bristol-Myers Squibb expanded its
territorial rights to develop and commercialize Opdivo globally
except in Japan, South Korea and Taiwan, where Ono had retained all
rights to the compound at the time. On July 23, 2014, Bristol-Myers
Squibb and Ono further expanded the companies’ strategic
collaboration agreement to jointly develop and commercialize
multiple immunotherapies – as single agents and combination
regimens – for patients with cancer in Japan, South Korea and
Taiwan.
About Bristol-Myers
Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol-Myers Squibb, visit us
at BMS.com or follow us on LinkedIn, Twitter,
YouTube and Facebook.
About Calithera
Biosciences
Calithera Biosciences, Inc. is 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. Calithera’s lead product
candidate, CB-839, is an inhibitor of glutaminase. CB-839 takes
advantage of the pronounced dependency many cancers have on the
nutrient glutamine for growth and survival. It is currently being
evaluated in Phase 1/2 clinical trials in combination with standard
of care agents. CB-1158 is an investigational immuno-oncology
metabolic checkpoint inhibitor designed to target arginase, a
critical immunosuppressive enzyme responsible for T-cell
suppression by myeloid-derived suppressor cells (MDSCs). Arginase
depletes arginine, a nutrient that is critical for the activation,
growth and survival of the body’s cancer-fighting immune cells,
known as cytotoxic T-cells. CB-1158 is being developed in
collaboration with Incyte Corporation and is currently in a Phase I
clinical trial. Calithera is headquartered in South San Francisco,
California. For more information about Calithera, please visit
http://www.calithera.com/.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains “forward-looking statements” as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are
based on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking
statement can be guaranteed. Among other risks, there can be
no guarantee that CB-839 in combination with Opdivo, will be
successfully developed or approved for any of the indications
described in this release. Forward-looking statements in this
press release should be evaluated together with the many
uncertainties that affect Bristol-Myers Squibb's business,
particularly those identified in the cautionary factors discussion
in Bristol-Myers Squibb's Annual Report on Form 10-K for the year
ended December 31, 2016 in our Quarterly Reports on Form 10-Q and
our Current Reports on Form 8-K. Bristol-Myers Squibb
undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise.
Calithera Biosciences Forward-Looking Statement
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 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 Opdivo with CB-839 to
drive improved and sustained efficacy in ccRCC 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170510005343/en/
Bristol-Myers SquibbMedia:Ken Dominski,
609-252-5251, ken.dominski@bms.comLisa McCormick Lavery,
609-252-7602, lisa.mccormicklavery@bms.comorInvestors:Tim
Power, 609-252-7509, timothy.power@bms.comBill Szablewski,
609-252-5894, william.szablewski@bms.comorCalithera BiosciencesJennifer McNealey,
650-870-1071, ir@Calithera.com
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