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Clovis Oncology Announces Presentations at 2019 ASCO Annual Meeting

May 16, 2019 Off By BusinessWire

Accepted abstracts highlight additional data from phase 3 ARIEL3
clinical trial, genomic data from phase 2 TRITON2 clinical trial, and
the designs of other ongoing rucaparib trials

BOULDER, Colo.–(BUSINESS WIRE)–lt;a href="https://twitter.com/search?q=%24CLVS&src=ctag" target="_blank"gt;$CLVSlt;/agt;–Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that four abstracts
featuring data for Rubraca^® (rucaparib) and ongoing studies
in multiple tumor types will be presented at the 2019 American Society
of Clinical Oncology (ASCO) Annual Meeting taking place May 31 – June 4
in Chicago.

The accepted abstracts summarize clinical trials in which Rubraca is
being evaluated as a single agent and as combination therapy with
nivolumab in a variety of solid tumor types including ovarian, prostate,
biliary tract and endometrial cancers. These include additional genomic
profiling data from TRITON2, and new data from extended follow up of
patients in ARIEL3.

“Increased understanding about the role of genomic mutations, as well as
the growing number and type of oncology therapies, offer tremendous
potential for us to more precisely target and improve treatment of the
most challenging cancers,” said Patrick J. Mahaffy, President and CEO of
Clovis Oncology. “In our own clinical development program and in
investigator-led studies, we are evaluating the utility of Rubraca in
multiple solid tumor types where there is genomic rationale, including
among patients with BRCA1/2 mutations as well as mutations in other
genes that play a role in DNA repair.”

The two Clovis Oncology-sponsored abstracts accepted for presentation at
the 2019 ASCO Annual Meeting comprise:

Abstract 5031 (Poster Board #143) – Genomic characteristics of
deleterious BRCA1 and BRCA2 alterations and associations with baseline
clinical factors in patients with metastatic castration-resistant
prostate cancer enrolled in TRITON2

Presenter: Wassim Abida, MD, PhD
Session: Genitourinary (Prostate) Cancer
Date/Time: Saturday, June 1, 1:15-4:15 p.m. Central Daylight Time (CDT)
Location: Hall A

Abstract 5522 (Poster Board #345) – Exploratory analysis of the
effect of maintenance rucaparib on post-progression outcomes in patients
with platinum-sensitive recurrent ovarian carcinoma and updated safety
data from the phase 3 study ARIEL3

Presenter: Robert L. Coleman, MD, FACOG, FACS
Session: Gynecologic Cancer
Date/Time: Saturday, June 1, 1:15-4:15 p.m. CDT
Location: Hall A

This poster (abstract #5522) will be discussed at the associated poster
discussion session on Saturday, June 1, 4:30-6:00 p.m. CDT in Room S406.

The two Clovis-sponsored posters will be available online at http://clovisoncology.com/pipeline/scientific-presentations/
once they are presented at the meeting.

Additionally, two investigator-sponsored abstracts describing
combination studies of Rubraca and nivolumab trials in progress are also
being presented:

Abstract TPS2663 (Poster Board #297b) – A phase Ib/IIa study of
rucaparib (PARP inhibitor) combined with nivolumab in metastatic
castrate-resistant prostate cancer and advanced/recurrent endometrial
cancer

Presenter: Raanan Alter, MD
Session: Developmental Immunotherapy and Tumor Immunobiology
Date/Time: Saturday, June 1, 8:00-11:00 a.m. CDT
Location: Hall A

Abstract TPS4153 (Poster Board #252a) – A multi-center phase II
trial of rucaparib in combination with nivolumab as maintenance therapy
for patients with advanced biliary tract cancer

Presenter: Vaibhav Sahai, MD
Session: Gastrointestinal (Noncolorectal) Cancer
Date/Time: Monday, June 3, 8:00-11:00 a.m. CDT
Location: Hall A

About Rubraca (rucaparib)

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3
being developed in multiple tumor types, including ovarian and
metastatic castration-resistant prostate cancers, as monotherapy, and in
combination with other anti-cancer agents. Exploratory studies in other
tumor types are also underway.

Rubraca U.S. FDA Approved Indications

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 mutations (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 1100 treated patients, MDS/AML
occurred in 12 patients (1.1%), including those in long-term follow-up.
Of these, five 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
cytogenetic analysis. 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 www.fda.gov/medwatch. You
may also report side effects to Clovis Oncology, Inc. at 1-844-258-7662.

Click
here or full Prescribing Information and additional Important Safety
Information.

Rubraca^®▼ (rucaparib) EU Authorized Use and
Important Safety Information

Rucaparib is indicated as monotherapy for the maintenance treatment of
adult patients with platinum-sensitive relapsed high-grade epithelial
ovarian, fallopian tube, or primary peritoneal cancer who are in
response (complete or partial) to platinum-based chemotherapy.

Rucaparib is indicated as monotherapy treatment of 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 chemotherapy.

Summary warnings and precautions: Haematological toxicity:
Patients should not start Rubraca until they have recovered from
haematological toxicities caused by previous chemotherapy (≤ CTCAE Grade
1). Complete blood count testing prior to starting treatment with
Rubraca and monthly thereafter is advised. Rubraca should be interrupted
or dose reduced and blood counts monitored weekly until recovery for the
management of low blood counts. Myelodysplastic syndrome/acute myeloid
leukaemia (MDS/AML): If MDS/AML is suspected, the patient should be
referred to a haematologist for further investigation. If MDS/AML is
confirmed, Rubraca should be discontinued. Photosensitivity: Patients
should avoid spending time in direct sunlight as they may burn more
easily. When outdoors, patients should wear protective clothing and
sunscreen with SPF of 50 or greater. Gastrointestinal toxicities: Low
grade (CTCAE Grade 1 or 2) nausea and vomiting may be managed with dose
reduction or interruption. Additionally, antiemetics may be considered
for treatment or prophylaxis.

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

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, for those
indications that require them, 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,
with additional office locations in the U.S. and Europe. Please visit www.clovisoncology.com
for more information.

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. Examples of forward-looking statements
contained in this press release include, among others, statements
regarding our plans for commercial launch in additional countries,
expectations for submission of regulatory filings, our expectations
regarding ongoing or planned trials and the timing and pace of
commencement of and enrollment in our clinical trials, including those
being considered, planned or conducted in collaboration with
partners. 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, whether
future study results will be consistent with study findings to date and
whether future study results will support continued development or
regulatory approval, the corresponding development pathways of our
companion diagnostics, the timing of availability of data from our
clinical trials and the results, 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.