Clovis Oncology Announces Availability of Rubraca®▼ (rucaparib) Tablets for Women with Relapsed Ovarian Cancer in Germany
-
Rubraca® (rucaparib) offers a new
monotherapy maintenance treatment option for eligible women with
platinum-sensitive relapsed ovarian cancer, regardless of BRCA status -
Rucaparib provided statistically significant improvement in
progression-free survival (PFS) versus placebo in all ovarian cancer
patients studied -
Some patients with residual disease at ARIEL3 study entry who were
treated with rucaparib showed further reduction in tumor burden,
including complete responses -
Most common Grade ≥3 adverse reaction was anemia; the only serious
adverse reaction occurring in >2% was anemia -
Rucaparib is the first PARP inhibitor to be approved for both
treatment and maintenance treatment among eligible women with ovarian
cancer in Europe -
Clovis Oncology intends to launch Rubraca in other European
countries to follow in 2019 and 2020
BOULDER, Colo. & MUNICH–(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 Rubraca®
(rucaparib) is now available by prescription in Germany 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. In addition, Rubraca 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.
On January 24, 2019, the European Commission (EC) expanded rucaparib’s
indication beyond its initial marketing authorization in Europe for the
treatment of advanced ovarian cancer in selected patients granted in May
2018. With this label expansion, rucaparib is now approved as
maintenance treatment for eligible patients regardless of their
BRCA-mutation status. Rucaparib is 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.
“I have been treating women with relapsed ovarian cancer under the
Rucaparib Access Program and I am confident that rucaparib represents an
important treatment option for women here in Germany,” “said Professor
Jalid Sehouli, Gynecologic Oncologist and head of the Charité European
Competence Center for Ovarian Cancer at the University of Berlin. “There
has been a significant need for additional treatment options for women
with relapsed ovarian cancer, and rucaparib’s approval in the
maintenance setting provides another option for these patients.”
“With this milestone approval in Germany, we are one step closer to
ensuring that Rubraca is available to all eligible women who may
potentially benefit,” said Patrick J. Mahaffy, President and CEO of
Clovis Oncology. “Rubraca has shown further tumor shrinkage as well as
prolonged progression-free survival in this maintenance setting,
therefore Rubraca represents an important step forward for women with
advanced ovarian cancer, regardless of their BRCA status.”
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
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). i
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 (median 10.8 mos vs 5.4 mos); the key secondary endpoint
of extending PFS as assessed by independent radiological review (IRR)
was also achieved (median 13.7 mos vs 5.4 mos). ii
In a prespecified exploratory analysis of patients in the ITT population
with measurable disease at baseline showed a tumor response was reported
in 18 percent of patients (n=26) on rucaparib compared to eight percent
of patients (n=5) on placebo, including seven percent (n=10) in the
rucaparib group who achieved a complete remission. i
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, anemia, abdominal pain, dysgeusia,
alanine aminotransferase (ALT) elevations, aspartate aminotransferase
(AST) elevations, decreased appetite, diarrhea, thrombocytopenia and
creatinine elevations. The majority of adverse reactions were mild to
moderate (Grade 1 or 2). ii
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%). ii
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, anemia, and fatigue/asthenia being the most
frequent adverse reactions leading to permanent discontinuation.ii
This release is only being distributed to members of the press and those
health care practitioners allowed to receive prescription drug promotion.
About Ovarian Cancer in Europe and Germany
In 2018, ovarian cancer was the sixth most common cancer among women in
Europe, with an estimated 68,000 women diagnosed and the fifth leading
cause of cancer deaths among women, with an estimated 45,000 deaths
annually. After initial therapy, many women’s disease will still recur,
and approximately 70% of patients with ovarian cancer will relapse
within the first three years following initial treatment. Germany has
the highest incidence of new cases and deaths caused by ovarian cancer
in Europe. The World Health Organization estimates that in 2018 there
were approximately 6,800 new cases of ovarian cancer and 5,400 ovarian
cancer-related deaths in the country.
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 the EU.
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 rucaparib until they have recovered from
haematological toxicities caused by previous chemotherapy (≤ CTCAE Grade
1). Complete blood count testing prior to starting treatment with
rucaparib and monthly thereafter is advised. Rucaparib 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, rucaparib 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 www.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 plans to launch Rubraca in additional European countries
and to make Rubraca available to additional eligible patients. 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 market potential of Rubraca,
including the performance of our sales and marketing efforts and the
success of competing drugs and therapeutic approaches, the performance
of our third-party manufacturers, our clinical development programs for
our drug candidates and those of our partners, and actions by the FDA,
the EMA or other regulatory authorities regarding data required to
support drug applications and whether to accept or approve drug
applications that may be filed, as well as their decisions regarding
drug labeling, reimbursement and pricing. 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 Summary of Product Characteristics Rubraca 200, 250, 300
mg film-coated tablets. Clovis Oncology Inc. Last updated February 2019.
Contacts
Clovis Investor Contacts:
Anna Sussman, 303.625.5022
asussman@clovisoncology.com
Breanna
Burkart, 303.625.5023
bburkart@clovisoncology.com
Clovis
Media Contacts:
U.S.
Lisa Guiterman, 301.217.9353
clovismedia@sambrown.com
Christy
Curran, 615.414.8668
clovismedia@sambrown.com
EU
Ann
Hughes, +44 (0) 7956 700 790
Ann.Hughes@publicisresolute.com
Germany
Martin
Kuegelgen +49 696 612 456 8332
Martin.Kuegelgen@mslgroup.com
