Clovis Oncology Announces European Commission Authorization of Rubraca®▼ (rucaparib) Tablets as Maintenance Treatment for Women with Relapsed Ovarian Cancer

• Rubraca^® (rucaparib) offers a new
  monotherapy option in Europe for the maintenance treatment of adults
  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, regardless of
  BRCA status
• Positive data from the phase 3 ARIEL3 clinical trial supported this
  expanded indication making Rubraca available to a larger patient
  population in an earlier line of therapy
• Rucaparib provided statistically-significant improvement in
  progression-free survival versus placebo in all patients studied
  (median 10.8 mos vs 5.4 mos) by investigator assessment
• Most common Grade ≥3 adverse reaction was anemia; the only serious
  adverse reaction occurring in >2% was anemia
• Clovis Oncology plans its initial launch of rucaparib as a
  maintenance therapy in Germany in Q1 2019

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 the European
Commission (EC) has approved the use of Rubraca^®
(rucaparib) for a second indication, as monotherapy for the maintenance
treatment of adults 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. This
expands rucaparib’s indication beyond its initial marketing
authorization in Europe granted in May 2018 and with this label
expansion, rucaparib is now available to patients regardless of their
BRCA mutation status. Rucaparib was the first PARP inhibitor licensed
for an ovarian cancer treatment indication in the EU and is now the
first to be available for both treatment and maintenance treatment among
eligible patients.

The EC authorization is based on data from the phase 3 ARIEL3 clinical
trial, which found that rucaparib significantly improved
progression-free survival in all ovarian cancer patient populations
studied.ⁱ

For the full European approved prescribing information, please refer to
the Rubraca (rucaparib) Summary of Product Characteristics on the European
Medicines Agency website.

Ovarian cancer is the sixth deadliest cancer among women in Europe,
where more than 65,000 women are diagnosed annually.ⁱⁱ
Moreover, the 80 to 85 percent of women diagnosed in the later stages of
the disease (III and IV) have particularly poor outcomes.ⁱⁱⁱ
Ovarian cancer is challenging to treat, and most women will relapse
after surgery and chemotherapy. Multiple studies, including the
rucaparib ARIEL3 clinical trial, have demonstrated that maintenance
treatment with a PARP inhibitor significantly extends median progression
free survival (mPFS) as compared to observation (i.e., “watch and wait”
or placebo).ⁱ

“This EC authorization of rucaparib is an important step in ensuring
that it is available to all women who may potentially benefit,
regardless of their BRCA status,” said Patrick J. Mahaffy, President and
CEO of Clovis Oncology. “We believe that access to maintenance treatment
is extremely important for women with relapsed platinum-sensitive
ovarian cancer, and we are pleased that rucaparib can now be an option
for these women. As the only PARP inhibitor that has shown further tumor
shrinkage as well as prolonged progression-free survival in this
maintenance setting, we believe Rubraca represents an important step
forward for women with advanced ovarian cancer.”

The ARIEL3 trial was a double-blind, placebo-controlled clinical trial
of rucaparib that enrolled 564 women with recurrent epithelial ovarian,
fallopian tube or primary peritoneal cancer in complete or partial
response to platinum-based chemotherapy. Patients were randomized (2:1)
to receive rucaparib tablets 600mg twice daily (n=375) or placebo
(n=189).

ARIEL3 successfully achieved its primary endpoint, of extending
investigator-assessed progression-free survival (PFS) versus placebo in
all patients treated (intention-to-treat [ITT]), population, regardless
of BRCA status; the key secondary endpoint of extending PFS as assessed
by independent radiological review (IRR) was also achieved.

Parameter			Investigator assessment						IRR
			Rucaparib			Placebo			Rucaparib			Placebo
All patients
Patients, n			375			189			375			189
PFS events, n (%)			234 (62)			167 (88)			165 (44)			133 (70)
PFS, median in months (95% CI)			10.8 (8.3, 11.4)			5.4 (5.3, 5.5)			13.7 (11.0, 19.1)			5.4 (5.1, 5.5)
HR (95% CI)			0.36 (0.30, 0.45)						0.35 (0.28, 0.45)
p-value			<0.0001						<0.0001
tBRCA Group
Patients, n			130			66			130			66
PFS events, n (%)			67 (52)			56 (85)			42 (32)			42 (64)
PFS, median in months (95% CI)			16.6 (13.4, 22.9)			5.4 (3.4, 6.7)			26.8 (19.2, NA)			5.4 (4.9, 8.1)
HR (95% CI)			0.23 (0.16, 0.34)						0.20 (0.13, 0.32)
p-value			<0.0001						<0.0001

An exploratory analysis of patients in the ITT population with
measurable disease at baseline showed a tumor response was reported in
18% (95% CI 12%–26%) of patients (n=26) on rucaparib compared to 8% (95%
CI 3% – 17%) of patients (n=5) on placebo (p value = 0.0069), including
10 patients (7%) in the rucaparib group who achieved a complete
remission.

The overall safety profile of rucaparib is based on data from 937
patients with ovarian cancer treated with rucaparib monotherapy in
clinical trials. Adverse reactions occurring in ≥20% of patients were
nausea, fatigue/asthenia, vomiting, anaemia, abdominal pain, dysgeusia,
alanine aminotransferase (ALT) elevations, aspartate aminotransferase
(AST) elevations, decreased appetite, diarrhoea, thrombocytopenia and
creatinine elevations. The majority of adverse reactions were mild to
moderate (Grade 1 or 2).

Grade ≥3 adverse reactions occurring in >5% of patients were anemia
(23%), ALT elevations (10%), fatigue/asthenia (10%), neutropenia (8%),
thrombocytopenia (6%), and nausea (5%). The only serious adverse
reaction occurring in > 2% of patients was anemia (5%).

Adverse reactions that most commonly led to dose reduction or
interruption were anemia (20%), fatigue/asthenia (18%), nausea (16%),
thrombocytopenia (15%), and AST/ALT elevations (10%). Adverse reactions
leading to permanent discontinuation occurred in 10% of patients, with
thrombocytopenia, nausea, anaemia, and fatigue/asthenia being the most
frequent adverse reactions leading to permanent discontinuation.

About Rubraca^® (rucaparib)

Rucaparib 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^® (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, 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; please visit clovisoncology.com
for more information, including additional office locations in the U.S.
and Europe.

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 expectation of future development plans and the timing and
pace of commencement of and enrollment in our 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, the corresponding
development pathways of our companion diagnostics, the initiation,
enrollment and timing of our planned clinical trials and the results of
our 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.

ⁱ Coleman RL et al. Rucaparib maintenance treatment for
recurrent ovarian carcinoma after response to platinum therapy (ARIEL3):
a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet
2017;390:1949-1961.
ⁱⁱ World Health Organization.
Globocan 2012: estimated cancer incidence, mortality and prevalence
worldwide in 2012. Accessed 23 February 2018.
ⁱⁱⁱ
American Cancer Society. Survival rates for ovarian cancer, by stage. https://www.cancer.org/cancer/ovarian-cancer/detection-diagnosis-staging/survival-rates.html

Contacts

Clovis Investor Contacts:
Anna Sussman, 303.625.5022
asussman@clovisoncology.com
or
Breanna
Burkart, 303.625.5023
bburkart@clovisoncology.com

Clovis
Media Contacts:
U.S.
Lisa Guiterman, 301.217.9353
clovismedia@sambrown.com
or
Christy
Curran, 615.414.8668
clovismedia@sambrown.com

EU
Ann
Hughes, +44 (0) 7956 700 790
Ann.Hughes@publicisresolute.com