Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that the
National Institute for Health and Care Excellence (NICE) has
recommended that women with relapsed ovarian cancer in England have
access to rucaparib through the Cancer Drugs Fund (CDF).1 Rucaparib
is available for use within the CDF as an option for the
maintenance treatment of relapsed, platinum-sensitive high-grade
epithelial ovarian, fallopian tube or primary peritoneal cancer
that has responded to platinum-based chemotherapy in adults, based
on the conditions outlined in the managed access agreement.
"Ovacome welcomes the availability of rucaparib via the CDF as
an option for maintenance treatment of platinum-sensitive relapsed
high grade serous epithelial ovarian cancer regardless of BRCA
status or line of treatment in the relapsed maintenance setting,”
said Victoria Clare, CEO of Ovacome, a United Kingdom ovarian
cancer charity focused on providing support to anyone affected by
ovarian cancer. “It is vital that the expansion of available
maintenance options continues as maintenance treatments extend the
time between chemotherapies. Many women with relapsed ovarian
cancer know that they are facing a future of managing their disease
as a chronic illness.”
“For too long ovarian cancer treatment options beyond
chemotherapy or surgery have been limited, and today’s announcement
means that women with ovarian cancer have more choice in their
treatment than ever before,” said Annwen Jones, Chief Executive of
Target Ovarian Cancer, a United Kingdom ovarian cancer charity.
“Target Ovarian Cancer has long campaigned for better treatment for
women with ovarian cancer and we are delighted to see this latest
development.”
Approximately 6,400 women are diagnosed with ovarian cancer in
the UK every year, which equates to roughly 17 every day.2 Despite
advancements in treatment and care, more than 4,000 women still die
each year from ovarian cancer in the UK.2 Of those treated with
surgery and first line chemotherapy, approximately 70% of patients
will relapse within the first three years.3
“Inclusion of rucaparib in the CDF as an option for maintenance
treatment for patients with recurrent ovarian cancer responding to
platinum-based therapy regardless of BRCA mutation status or line
of treatment in the relapsed maintenance setting represents a
much-needed treatment option for women with recurrent ovarian
cancer,” said Professor Jonathan Ledermann, MD, Professor of
Medical Oncology, UCL Cancer Institute and UCL Hospitals, London,
global Principal Investigator for non-US sites in the ARIEL3 study.
“I am pleased that the CDF recommendation includes access for the
broad patient population evaluated in the ARIEL3 trial which
demonstrated rucaparib to be effective in eligible patients,
regardless of their BRCA mutation status, providing a
clinically-meaningful median progression-free survival of more than
one year across the entire population studied by independent
radiological review. This represents a significant step in the
effective management of relapsed ovarian cancer in the NHS in
England.”
The European Union (EU) conditional marketing authorization is
based on data from the pivotal Phase 3 ARIEL3 clinical trial.
ARIEL3 successfully achieved its primary endpoint of extending
investigator-assessed PFS versus placebo in all patients treated
(intention-to-treat, or ITT), population, regardless of BRCA status
(median 10.8 months vs 5.4 months).4,5 In addition, it successfully
achieved the key secondary endpoint of extending PFS by independent
radiological review versus placebo in all patients treated (ITT),
regardless of BRCA status (median 13.7 months vs 5.4 months).5 The
overall safety profile of rucaparib is based on data from 937
patients with ovarian cancer treated with rucaparib monotherapy in
clinical trials.5
“We welcome NICE’s recommendation to make rucaparib available
through the CDF to all eligible women in England who may
potentially benefit from this important therapeutic option,” said
Patrick J. Mahaffy, President and CEO of Clovis Oncology. “For
women with recurrent ovarian cancer, access to new treatments that
successfully demonstrate prolonged progression-free survival is
essential in the fight against this deadly disease and central to
Clovis Oncology’s mission to provide the right drug, to the right
patient at the right time.”
About Rubraca® (rucaparib)
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and
PARP3 that is being developed in multiple tumor types, including
ovarian and metastatic castration-resistant prostate cancer
(mCRPC), as monotherapy, and in combination with other anti-cancer
agents. Exploratory studies in other tumor types are also
underway.
Rubraca® (rucaparib) European Union (EU) Conditional
Marketing Authorization
Rubraca 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.
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 ≥ 2
prior lines of platinum-based chemotherapy, and who are unable to
tolerate further platinum-based chemotherapy.
Summary Warnings, Precautions and Safety
Efficacy of Rubraca as treatment for relapsed or progressive
EOC, FTC, or PPC has not been investigated in patients who have
received prior treatment with a PARP inhibitor. Therefore, use in
this patient population is not recommended.
The overall safety profile of rucaparib is based on data from
937 patients in clinical trials in ovarian cancer treated with
rucaparib monotherapy. Adverse reactions occurring in ≥ 20% of
patients receiving rucaparib were nausea, fatigue/asthenia,
vomiting, anaemia, abdominal pain, dysgeusia, ALT elevations, AST
elevations, decreased appetite, diarrhoea, thrombocytopenia and
creatinine elevations. The majority of adverse reactions were mild
to moderate (Grade 1 or 2).
The ≥ Grade 3 adverse reactions occurring in > 5% of patients
were anaemia (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
anaemia (5%).
Adverse reactions that most commonly led to dose reduction or
interruption were anaemia (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.
During treatment with rucaparib, events of myelosuppression
(anaemia, neutropenia, thrombocytopenia) may be observed and are
typically first observed after 8-10 weeks of treatment with
rucaparib. These reactions are manageable with routine medical
treatment and/or dose adjustment for more severe cases. Complete
blood count testing prior to starting treatment with rucaparib and
monthly thereafter, is advised. Patients should not start rucaparib
until they have recovered from haematological toxicities caused by
previous chemotherapy (≤ CTCAE Grade 1).
Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML),
including cases with fatal outcome, have been reported in patients
who received rucaparib. The duration of therapy with rucaparib in
patients who developed MDS/AML varied from less than 1 month to
approximately 28 months. If MDS/AML is suspected, the patient
should be referred to a haematologist for further investigations,
including bone marrow analysis and blood sampling for cytogenetics.
If, following investigation for prolonged haematological toxicity,
MDS/AML is confirmed, rucaparib should be discontinued.
Further information should be obtained from the Rucaparib
Summary of Product Characteristics (SmPC) found here:
https://www.medicines.org.uk/emc/product/10028/smpc.
This medicine is subject to additional monitoring. This will
allow quick identification of new safety information. Side effects
should be reported. See https://yellowcard.mhra.gov.uk for how to
report side effects.
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 to launch Rubraca in additional
European countries, including the United Kingdom, 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.
References
- NICE final appraisal document (FAD) for Rucaparib for
maintenance treatment of relapsed platinum-sensitive ovarian,
fallopian tube or peritoneal cancer. Available at
https://www.nice.org.uk/guidance/published?type=ta
- World Health Organization. GLOBOCAN: estimated cancer
incidence, mortality and prevalence worldwide in 2018. Available at
http://gco.iarc.fr/ Last accessed October 2019.
- Ledermann J, et al. Newly diagnosed and relapsed epithelial
ovarian carcinoma: ESMO Clinical Practice Guidelines for diagnosis,
treatment and follow-up. Ann Oncol 2013;24(suppl 6):vi24–32.
- 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;390:1949–61.
- Summary of Product Characteristics Rubraca 200, 250, 300 mg
film-coated tablets. Available at:
https://www.ema.europa.eu/en/documents/product-information/rubraca-epar-product-information_en.pdf.
Last accessed October 2019.
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version on businesswire.com: https://www.businesswire.com/news/home/20191011005292/en/
Clovis investor contacts: Anna Sussman, +1 303.625.5022
asussman@clovisoncology.com or Breanna Burkart, +1 303.625.5023
bburkart@clovisoncology.com
Clovis media contacts: U.S. Lisa Guiterman, +1
301.217.9353 clovismedia@sambrown.com
EU Jake Davis, +44 (0) 203.946.3538
Jake.Davis@publicisresolute.com or Joanna Sullivan +44 (0)
207.173.4191 Joanna.Sullivan@publicisresolute.com
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