Market Overview

Clovis Oncology Announces First Patient Enrolled in the Phase 3 ATHENA Trial


Trial to Evaluate the Combination of Rubraca®
(rucaparib) and OPDIVO
® (nivolumab)
in Patients with Advanced Ovarian Cancer

Clovis Oncology, Inc. (NASDAQ:CLVS) announced today the randomization
of the first patient in the Phase 3 ATHENA trial evaluating the
combination of Clovis' Rubraca® (rucaparib), a
poly (ADP ribose) polymerase inhibitor (PARP), and Bristol-Myers
Squibb's PD-1 inhibitor, OPDIVO® (nivolumab), for the
treatment of advanced ovarian cancer. ATHENA, sponsored by Clovis, is
part of a clinical collaboration with Bristol-Myers Squibb and is being
conducted in association with the Gynecologic Oncology Group (GOG) and
the European Network for Gynecological Oncological Trials (ENGOT). GOG
and ENGOT are the two largest cooperative groups in the U.S. and Europe
dedicated to the treatment of gynecological cancers.

"I am pleased the GOG and ENGOT are conducting the first trial designed
to investigate whether the combination of a PARP inhibitor and PD-1
blocking antibody can demonstrate not only an improvement in
progression-free survival in the first-line maintenance setting for
women with advanced ovarian cancer, but also whether the combination can
change the natural course of the disease by delaying or reducing
recurrence following front-line therapy," said Brad Monk, M.D., FACS,
FACOG, Arizona Oncology (US Oncology Network), Professor, Gynecologic
Oncology at University of Arizona and Creighton University, Medical
Director of US Oncology Research Gynecology program in Phoenix, Arizona
and Lead Investigator of the ATHENA trial.

"Rubraca combination trials such as ATHENA are encouraging to see,
because the possible implications are particularly meaningful for women
with advanced ovarian cancer, who need a wide range of treatment
options," said Dr. Rebecca Kristeleit, Clinical Senior Lecturer and
Consultant Medical Oncologist, University College London, U.K. and
ATHENA ENGOT/Non-U.S. Lead Investigator. "The participation by the GOG
and the ENGOT in the evaluation of a PARP inhibitor in combination with
a PD-1 agent reflects the interest around this approach."

ATHENA is a Phase 3, randomized, multinational, double-blind,
placebo-controlled, four-arm trial evaluating Rubraca and Opdivo as
maintenance treatment following response to front-line treatment in
newly-diagnosed ovarian cancer patients. Response to treatment will be
analyzed based on homologous recombination (HR) status of tumor samples.
The primary endpoint is investigator assessed progression-free survival
(PFS); secondary endpoints include overall survival (OS), objective
response rate (ORR), duration of response (DOR), and safety.

"The initiation of the Phase 3 ATHENA trial is an important milestone
for Clovis and a critical step towards helping women with advanced
ovarian cancer, who are in need of new treatment options. We are
particularly excited about the potential clinical utility of Rubraca in
combination with Opdivo in this setting," said Patrick J.
Mahaffy, President and Chief Executive Officer of Clovis Oncology. "The
importance of this trial is also underscored by the participation of
ENGOT and GOG, which we anticipate may facilitate enrollment."

The trial will enroll approximately 1,000 ovarian cancer patients at
clinical trial centers in the United States and internationally. More
information about the trial is available at,
identifier NCT03522246.

About Rubraca® (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3
being developed in multiple tumor types, including ovarian, metastatic
castration-resistant prostate, and bladder cancers, as monotherapy, and
in combination with other anti-cancer agents. Exploratory studies in
other tumor types are also underway. Clovis holds worldwide rights for
Rubraca. Rubraca is an unlicensed medical product outside of the U.S.
and Europe.

Rubraca EU Authorized Use

Rubraca is licensed for adult patients with platinum sensitive, relapsed
or progressive, BRCA mutated (germline and/or somatic), high-grade
epithelial ovarian, fallopian tube, or primary peritoneal cancer, who
have been treated with two or more prior lines of platinum based
chemotherapy, and who are unable to tolerate further platinum based

to access the current Summary of Product Characteristics.
Healthcare professionals should report any suspected adverse reactions
via their national reporting systems.

Rubraca U.S. FDA Approved Indications and Important Safety Information

Rubraca is indicated as monotherapy for the maintenance treatment of
adult patients with recurrent epithelial ovarian, fallopian tube, or
primary peritoneal cancer who are in a complete or partial response to
platinum-based chemotherapy.

Rubraca is indicated as monotherapy for the treatment of adult patients
with deleterious BRCA mutation (germline and/or somatic) associated
epithelial ovarian, fallopian tube, or primary peritoneal cancer who
have been treated with two or more chemotherapies and selected for
therapy based on an FDA-approved companion diagnostic for Rubraca.

Select Important Safety Information

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur
uncommonly in patients treated with Rubraca, and are potentially fatal
adverse reactions. In approximately 1,100 treated patients, MDS/AML
occurred in 12 patients (1.1%), including those in long term follow-up.
Of these, 5 occurred during treatment or during the 28-day safety
follow-up (0.5%). The duration of Rubraca treatment prior to the
diagnosis of MDS/AML ranged from 1 month to approximately 28 months. The
cases were typical of secondary MDS/cancer therapy-related AML; in all
cases, patients had received previous platinum-containing regimens
and/or other DNA damaging agents. Do not start Rubraca until patients
have recovered from hematological toxicity caused by previous
chemotherapy (≤ Grade 1).

Monitor complete blood counts for cytopenia at baseline and monthly
thereafter for clinically significant changes during treatment. For
prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or
reduce dose (see Dosage and Administration (2.2) in full Prescribing
Information) and monitor blood counts weekly until recovery. If the
levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML
is suspected, 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 in ARIEL3 (≥ 20%; Grade 1-4) were nausea
(76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash
(43%), dysgeusia (40%), anemia (39%), AST/ALT elevation (38%),
constipation (37%), vomiting (37%), diarrhea (32%), thrombocytopenia
(29%), nasopharyngitis/upper respiratory tract infection (29%),
stomatitis (28%), decreased appetite (23%), and neutropenia (20%).

Most common laboratory abnormalities in ARIEL3 (≥ 25%; Grade 1-4) were
increase in creatinine (98%), decrease in hemoglobin (88%), increase in
cholesterol (84%), increase in alanine aminotransferase (ALT) (73%),
increase in aspartate aminotransferase (AST) (61%), decrease in
platelets (44%), decrease in leukocytes (44%), decrease in neutrophils
(38%), increase in alkaline phosphatase (37%), and decrease in
lymphocytes (29%).

Most common adverse reactions in Study 10 and ARIEL2 (≥ 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 in Study 10 and ARIEL2 (≥ 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%).

Co-administration of Rubraca can increase the systemic exposure of
CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the
risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A,
CYP2C9, or CYP2C19 substrates, if clinically indicated. If
co-administration with warfarin (a CYP2C9 substrate) cannot be avoided,
consider increasing frequency of international normalized ratio (INR)
monitoring. Because of the potential for serious adverse reactions in
breast-fed children from Rubraca, advise lactating women not to
breastfeed during treatment with Rubraca and for 2 weeks after the last
dose. You may report side effects to the FDA at 1-800-FDA-1088 or
You may also report side effects to Clovis Oncology, Inc. at

for full Prescribing Information and additional Important
Safety Information.

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
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 the timing and pace of commencement
of and enrollment in our clinical trials, including those being planned
or conducted in collaboration with partners, and the potential results
of such clinical trials. 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 our
clinical development programs for our drug candidates and those of our
partners, and the initiation, enrollment, timing and results of our
planned clinical trials. 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.

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