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Bristol-Myers Squibb and Clovis Oncology Announce a Broad Clinical Collaboration to Evaluate Combination of Opdivo (Nivolumab) and Rubraca® (Rucaparib) in Phase 2 and Pivotal Phase 3 Clinical Trials in Multiple Tumor Types

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Pivotal Phase 3 Trials Planned for 2017 will Evaluate Rubraca in
Combination with Opdivo, Rubraca as Monotherapy, and Opdivo as
Monotherapy in First Line Maintenance Treatment for Advanced Ovarian and
Advanced Triple-Negative Breast Cancers

Phase 2 Trial will Evaluate Opdivo in Combination with Rubraca and
Other Compounds in Metastatic Castration-Resistant Prostate Cancer

Bristol-Myers
Squibb Company
(NYSE:BMY) and Clovis
Oncology, Inc.
(NASDAQ:CLVS) announced the companies have entered
into a clinical collaboration agreement to evaluate the combination of
Bristol-Myers Squibb's immunotherapy Opdivo
and Clovis Oncology's poly (ADP-ribose) polymerase (PARP) inhibitor Rubraca
in pivotal phase 3 clinical trials in:

  • Advanced ovarian cancer: First-line
    maintenance treatment study to evaluate Rubraca + Opdivo,
    Rubraca, Opdivo and placebo in newly diagnosed patients
    with stage III/IV high-grade ovarian, fallopian tube, or primary
    peritoneal cancer who have completed platinum-based chemotherapy.
  • Advanced triple-negative breast cancers
    (TNBC): First-line maintenance treatment study to evaluate Rubraca
    + Opdivo, Rubraca, Opdivo and chemotherapy in
    patients with stage IV or recurrent locally advanced inoperable TNBC
    associated with a homologous recombination deficiency (HRD).

The collaboration will also include a Phase 2 study to evaluate the
safety and efficacy of Opdivo in combination with Rubraca
in patients with metastatic castration-resistant prostate cancer
(mCRPC). The Opdivo + Rubraca combination in mCRPC will be
conducted as an arm of a larger Bristol-Myers Squibb-sponsored study.

Rubraca is an oral, small molecule inhibitor of PARP enzymes,
including PARP-1, PARP-2, and PARP-3, being developed for the treatment
of solid tumors associated with homologous recombination deficiency
(HRD), defined as the presence of a deleterious BRCA1 or BRCA2 mutation,
a deleterious mutation in another gene involved in DNA damage repair,
and/or a high percentage of tumor genome with LOH, a phenotypic
consequence of HRD. Opdivo is a human programmed death receptor-1
(PD-1) blocking antibody that binds to the PD-1 receptor expressed on
activated T-cells and other immune cells. The overlap in immuno-biology
linked to these agents supports the potential for synergy of PARP
inhibition and PD-1 blockade. Preclinical evidence has demonstrated that
PARP inhibition can trigger inflammation, cell death and increase T-cell
infiltration within tumors.

"We are very enthusiastic about studying Rubraca and Opdivo
in combination, and the potential to create new treatment options for
patients with multiple tumor types, as well as for patients beyond those
with BRCA mutations," said Patrick J. Mahaffy, President, and CEO
of Clovis Oncology. "This substantial clinical collaboration in ovarian,
triple-negative breast and prostate cancers represents a significant
effort by Clovis and Bristol-Myers Squibb to realize that potential."

"This clinical collaboration addresses areas of unmet medical need where
the combination of Opdivo and Rubraca may lead to an
additional treatment option for patients with difficult to treat
cancers," said Fouad Namouni, M.D., head of Oncology Development,
Bristol-Myers Squibb. "We are committed to investigating a wide range of
oncology therapies and look forward to studying the combination of
Clovis' PARP inhibitor and our immunotherapy."

The planned multi-arm clinical trials will be conducted in the U.S.,
Europe, and possibly additional countries. Clovis will be the study
sponsor and conducting party for the ovarian cancer study and
Bristol-Myers Squibb will be the study sponsor and conducting party for
the breast and prostate cancer studies. Specific terms of the agreement
were not disclosed. All three studies are expected to begin before the
end of 2017.

About Ovarian Cancer

According to the World Cancer Research Fund International, ovarian
cancer is the seventh most common cancer in women worldwide (18th
most common cancer overall), with 239,000 new cases diagnosed in 2012.
There are often no specific initial symptoms, and in an estimated 80 to
85% of ovarian cancer cases, the cancer has spread to other parts of the
body before a person is diagnosed and can be treated. Ovarian cancer
ranks fifth in cancer deaths in the U.S. and causes more deaths than any
other cancer of the female reproductive system.

About Triple-Negative Breast Cancer

Breast cancer is the most frequently diagnosed cancer in women worldwide
with nearly 1.7 million new cases diagnosed in 2012, accounting for 25%
of all new cancer cases in women according to the International Agency
for the Research of Cancer (IARC) of the World Health Organization. More
than one out of every 10 breast cancers are found to be triple-negative,
meaning the cancer does not have the biomarkers that predict response to
hormonal therapy or therapies that target HER2 receptors. Triple
negative tumors are often aggressive and have a poorer prognosis
compared to hormone receptor-positive breast cancers.

About Castration-Resistant Prostate Cancer

Prostate cancer is the second most frequently diagnosed cancer in men,
with 1.1 million new cases diagnosed worldwide in 2012. Unlike many
early-stage prostate cancers that need normal levels of testosterone to
grow, castration-resistant prostate cancer (CRPC) continues to grow even
when the amount of testosterone in the body is reduced to castrate
levels. CRPC patients have a very high likelihood of having or
developing metastases, meaning the cancer has spread to other areas of
the body. While the 5-year survival rate for most stages of prostate
cancer is almost 100%; the 5-year survival rate for prostate cancer that
has spread to distant lymph nodes, bones, or other organs is
approximately 29%.

Bristol-Myers Squibb & Immuno-Oncology:
Advancing Oncology Research

At Bristol-Myers Squibb, patients are at the center of everything we do.
Our vision for the future of cancer care is focused on researching and
developing transformational Immuno-Oncology (I-O) medicines for
hard-to-treat cancers that could potentially improve outcomes for these
patients.

We are leading the scientific understanding of I-O through our extensive
portfolio of investigational compounds and approved agents. Our
differentiated clinical development program is studying broad patient
populations across more than 50 types of cancers with 14 clinical-stage
molecules designed to target different immune system pathways. Our deep
expertise and innovative clinical trial designs position us to advance
I-O/I-O, I-O/chemotherapy, I-O/targeted therapies and I-O/radiation
therapies across multiple tumors and potentially deliver the next wave
of therapies with a sense of urgency. We also continue to pioneer
research that will help facilitate a deeper understanding of the role of
immune biomarkers and how patients' individual tumor biology can be used
as a guide for treatment decisions throughout their journey.

We understand making the promise of I-O a reality for the many patients
who may benefit from these therapies requires not only innovation on our
part but also close collaboration with leading experts in the field. Our
partnerships with academia, government, advocacy, and biotech companies
support our collective goal of providing new treatment options to
advance the standards of clinical practice.

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.

About Rubraca

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and
PARP3 being developed in ovarian cancer as well as several additional
solid tumor indications. In December 2016, Rubraca (rucaparib)
tablets became the first PARP inhibitor approved by the U.S. Food and
Drug Administration (FDA) as monotherapy for treatment of patients with
deleterious BRCA mutation (germline and/or somatic) associated advanced
ovarian cancer who have been treated with two or more prior
chemotherapies.

During the fourth quarter of 2016, the Marketing Authorization
Application (MAA) submission in Europe for Rubraca in the same ovarian
cancer treatment indication was submitted and accepted for review. By
the end of October 2017, Clovis Oncology intends to submit a
supplemental New Drug Application (sNDA) in the U.S. for a second line
or later maintenance treatment indication in ovarian cancer based on the
ARIEL3 data, and in early 2018, plans to file an MAA in Europe for the
maintenance treatment indication upon receipt of a potential approval
for the treatment indication. Studies open for enrollment or under
consideration include ovarian, prostate, breast, pancreatic,
gastroesophageal, bladder, lung, and urothelial cancers. Clovis is also
developing Rubraca in patients with mutant BRCA tumors and other
DNA repair deficiencies beyond BRCA – commonly referred to as homologous
recombination deficiencies, or HRD. Clovis holds worldwide rights for Rubraca.

OPDIVO AND YERVOY INDICATIONS & IMPORTANT
SAFETY INFORMATION

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
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 (e.g., 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 infections, 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%).

Checkmate Trials and Patient Populations

Checkmate 067 - advanced melanoma alone or in combination with
YERVOY; Checkmate 037 and 066 - advanced melanoma; Checkmate
017
- squamous non-small cell lung cancer (NSCLC); Checkmate 057
- non-squamous NSCLC; Checkmate 025 - renal cell carcinoma; Checkmate
205/039
- classical Hodgkin lymphoma; Checkmate 141
squamous cell carcinoma of the head and neck; Checkmate 275 -
urothelial carcinoma.

Please see U.S. Full Prescribing Information for OPDIVO
and YERVOY,
including Boxed WARNING regarding immune-mediated adverse reactions
for YERVOY.

RUBRACA INDICATION AND IMPORTANT SAFETY
INFORMATION

Rubraca® (rucaparib) is indicated as monotherapy for the treatment of
patients with deleterious BRCA mutation (germline and/or somatic)
associated advanced ovarian cancer who have been treated with two or
more chemotherapies. Select patients for therapy based on an
FDA-approved companion diagnostic for Rubraca.

This indication is approved under accelerated approval based on
objective response rate and duration of response. Continued approval for
this indication may be contingent upon verification and description of
clinical benefit in confirmatory trials.

Select Important Safety Information

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML)
was reported in 2 of 377 (0.5%) patients with ovarian cancer treated
with Rubraca. The duration of Rubraca treatment prior to the diagnosis
of MDS/AML was 57 days and 539 days. Both patients received prior
treatment with platinum and other DNA damaging agents.

AML was reported in 2 (<1%) patients with ovarian cancer enrolled in a
blinded, randomized trial evaluating Rubraca versus placebo. One case of
AML was fatal. The duration of treatment prior to the diagnosis of AML
was 107 days and 427 days. Both patients had received prior treatment
with platinum and other DNA damaging agents.

Do not start Rubraca until patients have recovered from hematological
toxicity caused by previous chemotherapy (≤ Grade 1).

Monitor complete blood count testing at baseline and monthly thereafter.
For prolonged hematological toxicities, interrupt Rubraca and monitor
blood counts weekly until recovery. If the levels have not recovered to
Grade 1 or less after 4 weeks, refer the patient to a hematologist for
further investigations, including bone marrow analysis and blood sample
for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

Based on its mechanism of action and findings from animal studies,
Rubraca can cause fetal harm when administered to a pregnant woman.
Apprise pregnant women of the potential risk to a fetus. Advise females
of reproductive potential to use effective contraception during
treatment and for 6 months following the last dose of Rubraca.

Most common adverse reactions (≥ 20%; Grade 1-4) were nausea (77%),
asthenia/fatigue (77%), vomiting (46%), anemia (44%), constipation
(40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%),
abdominal pain (32%), dyspnea (21%), and thrombocytopenia (21%).

Most common laboratory abnormalities (≥ 35%; Grade 1-4) were increase in
creatinine (92%), increase in alanine aminotransferase (ALT) (74%),
increase in aspartate aminotransferase (AST) (73%), decrease in
hemoglobin (67%), decrease in lymphocytes (45%), increase in cholesterol
(40%), decrease in platelets (39%), and decrease in absolute neutrophil
count (35%).

Because of the potential for serious adverse reactions in breast-fed
infants from Rubraca, advise lactating women not to breastfeed during
treatment with Rubraca and for 2 weeks after the final dose.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Clovis Oncology, Inc. at
1-844-258-7662.

Please see RUBRACA
full Prescribing Information for additional Important Safety Information.

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 LinkedInTwitter,
YouTube
and Facebook.

About Clovis Oncology

Clovis Oncology, Inc. is a biopharmaceutical company focused on
acquiring, developing and commercializing innovative anti-cancer agents
in the U.S., Europe and additional international markets. Clovis
Oncology targets development programs at specific subsets of cancer
populations, and simultaneously develops, with partners, diagnostic
tools intended to direct a compound in development to the population
that is most likely to benefit from its use. Clovis Oncology is
headquartered in Boulder, Colorado, and has additional offices in San
Francisco, California and Cambridge, UK. Please visit clovisoncology.com for
more information.

Clovis Oncology Forward-Looking Statement

To the extent that statements contained in this press release are not
descriptions of historical facts regarding Clovis Oncology, they are
forward-looking statements reflecting the current beliefs and
expectations of management made pursuant to the safe harbor provisions
of the Private Securities Litigation Reform Act of 1995. Examples of
forward-looking statements contained in this press release include,
among others, statements regarding our expectation of timing for
submission of the sNDA for Rubraca, filing of an MAA for Rubraca in
Europe and future development plans. Such forward-looking statements
involve substantial risks and uncertainties that could cause our future
results, performance, or achievements to differ significantly from that
expressed or implied by the forward-looking statements. Such risks and
uncertainties include, among others, the uncertainties inherent in the
clinical development program for Rubraca in combination with Opdivo,
including the result of clinical trials, whether future study results
will be consistent with study findings to-date, the corresponding
development pathways of our companion diagnostics, the timing of
availability of data from our clinical trials and the results of our
clinical trials, the initiation, enrollment and timing of our planned
clinical trials, actions by the FDA, the EMA or other regulatory
authorities regarding whether to approve drug applications that may be
filed, as well as their decisions that may affect drug labeling, pricing
and reimbursement, and other matters that could affect the availability
or commercial potential of our drug candidates or companion
diagnostics. Clovis Oncology does not undertake to update or revise any
forward-looking statements. A further description of risks and
uncertainties can be found in Clovis Oncology's filings with the
Securities and Exchange Commission, including its Annual Report on Form
10-K and its reports on Form 10-Q and Form 8-K.

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
Rubraca
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.

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