- Rubraca® (rucaparib) offers a new monotherapy maintenance
treatment option for eligible women with relapsed,
platinum-sensitive ovarian cancer, who harbor either a BRCA1/2
mutation or are BRCA wild-type
- Rucaparib provided statistically significant improvement in
progression-free survival (PFS) versus placebo in all ovarian
cancer patients studied1
- Some patients with residual disease at ARIEL3 study entry who
were treated with rucaparib showed further reduction in tumor
burden, including complete responses1
- Most common Grade ≥3 adverse reaction was anemia; the only
serious adverse reaction occurring in >2 percent of patients was
anemia2
- Rucaparib now available in multiple countries across
Europe
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that
Rubraca® (rucaparib) is now available and reimbursed in France.
Rubraca® (rucaparib) is an option for monotherapy maintenance
treatment for adults with relapsed, platinum-sensitive high-grade
epithelial ovarian, fallopian tube or primary peritoneal cancer
that has responded to platinum-based chemotherapy.2 Rucaparib is
indicated for eligible patients regardless of BRCA status, which
means it can be prescribed for women who harbor a BRCA mutation or
who are BRCA wild-type.2
“This is excellent news as this represents an important new
option for patients with relapsed ovarian cancer who have responded
to platinum-based chemotherapy,” said a spokesperson for IMAGYN,
the only French network of patient associations involved in the
fight against ovarian cancer and gynecological tumors. “For too
long, ovarian cancer treatment options beyond chemotherapy, surgery
and anti-angiogenic therapy have been limited, and today’s
announcement means that eligible women with ovarian cancer have
more choice in their treatment than ever before.”
Approximately 5,000 women are diagnosed with ovarian cancer in
France every year, which equates to roughly 14 every day.3 Ovarian
cancer is the eighth most common cancer in women and the fourth
most fatal cancer in France.4 In addition, approximately 25 percent
of ovarian cancer patients harbor a BRCA1/2 mutation in the tumor,
correlating to improved outcomes to platinum and PARP inhibitors
therapy.5,6 The majority of women diagnosed with ovarian cancer are
BRCA wild-type; these patients typically have a worse prognosis.5,6
Of those treated with surgery and first line chemotherapy,
approximately 70 percent of patients will relapse within the first
three years.7
“The availability of rucaparib is good news, as ovarian cancer
is a disease often diagnosed at an advanced stage and many women
may have a poor prognosis,” said Professor Isabelle Ray-Coquard,
President of the GINECO Group, which specializes in clinical and
translational research in the field of women's cancers, and sets up
and coordinates clinical trials in France and abroad. “Patients
with relapsed ovarian cancer may have many debilitating symptoms,
and it is important that new treatments such as rucaparib are made
available to the eligible patients that may benefit from them.”
The European Union (EU) authorization is based on data from the
pivotal phase 3 ARIEL3 clinical trial, which found that rucaparib
significantly improved PFS in all ovarian cancer patient
populations studied.1 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).1,2 In
this population, the risk of progression or death has been
decreased by 64%.1 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).2 The overall safety
profile of rucaparib is based on data from 937 patients with
ovarian cancer treated with rucaparib monotherapy in clinical
trials.2
"The fact that rucaparib is now reimbursed and available in
France means there is a new treatment for patients with
platinum-sensitive relapsed ovarian cancer,” said Dr. Anne Floquet,
President of the SFOG, the French Society for Gyneco-Oncology. “I
am very proud to have been able to participate in the ARIEL3 study,
which demonstrates the effectiveness of rucaparib in improving
patients' progression-free survival. I am also delighted to be able
to prescribe this treatment as it may offer benefits for eligible
patients."
“We are working to make Rubraca available in multiple countries
across Europe, and with the reimbursement and availability of
Rubraca in France, it is now a treatment option for eligible
patients in Germany, England, Italy, and in France,” said Patrick
J. Mahaffy, President and CEO of Clovis Oncology. “Rubraca is
effective across a broad population of women with relapsed ovarian
cancer and is an important step in the ovarian cancer treatment
pathway for eligible patients.”
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) authorized use and
Important Safety Information
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.
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.
Summary warnings and precautions:
Hematological toxicity
During treatment with Rubraca, events of myelosuppression
(anemia, neutropenia, thrombocytopenia) may be observed and are
typically first observed after 8–10 weeks of treatment with
Rubraca. 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 Rubraca, and
monthly thereafter, is advised. Patients should not start Rubraca
treatment until they have recovered from hematological toxicities
caused by previous chemotherapy (CTCAE grade ≥1).
Supportive care and institutional guidelines should be
implemented for the management of low blood counts for the
treatment of anemia and neutropenia. Rubraca should be interrupted
or dose reduced according to Table 1 (see Posology and Method of
Administration [4.2] of the Summary of Product Characteristics
[SPC]) and blood counts monitored weekly until recovery. If the
levels have not recovered to CTCAE grade 1 or better after 4 weeks,
the patient should be referred to a hematologist for further
investigations.
MDS/AML
MDS/AML, including cases with fatal outcome, have been reported
in patients who received Rubraca. The duration of therapy with
Rubraca 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
hematologist for further investigations, including bone marrow
analysis and blood sampling for cytogenetics. If, following
investigation for prolonged hematological toxicity, MDS/AML is
confirmed, Rubraca should be discontinued.
Photosensitivity
Photosensitivity has been observed in patients treated with
Rubraca. Patients should avoid spending time in direct sunlight
because they may burn more easily during Rubraca treatment; when
outdoors, patients should wear a hat and protective clothing, and
use sunscreen and lip balm with sun protection factor of 50 or
greater.
Gastrointestinal toxicities
Gastrointestinal toxicities (nausea and vomiting) are frequently
reported with Rubraca, and are generally low grade (CTCAE grade 1
or 2), and may be managed with dose reduction (refer to Posology
and Method of Administration [4.2], Table 1 of the SPC) or
interruption. Antiemetics, such as 5-HT3 antagonists,
dexamethasone, aprepitant and fosaprepitant, can be used as
treatment for nausea/vomiting and may also be considered for
prophylactic (i.e. preventative) use prior to starting Rubraca. It
is important to proactively manage these events to avoid prolonged
or more severe events of nausea/vomiting which have the potential
to lead to complications such as dehydration or
hospitalization.
Embryofetal toxicity
Rubraca can cause fetal harm when administered to a pregnant
woman based on its mechanism of action and findings from animal
studies. In an animal reproduction study, administration of Rubraca
to pregnant rats during the period of organogenesis resulted in
embryo-fetal toxicity at exposures below those in patients
receiving the recommended human dose of 600 mg twice daily (see
Preclinical Safety Data [5.3] of the SPC).
Pregnancy/contraception
Pregnant women should be informed of the potential risk to a
fetus. Women of reproductive potential should be advised to use
effective contraception during treatment and for 6 months following
the last dose of Rubraca (see section 4.6 of the SPC). A pregnancy
test before initiating treatment is recommended in women of
reproductive potential.
Click here to access the current SPC. 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 to launch Rubraca in additional
European countries, including availability of Rubraca in France,
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 and our distribution network, 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
- 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
Accessed December 2019
- World Health Organization. GLOBOCAN: estimated cancer
incidence, mortality and prevalence worldwide in 2018. Available at
http://gco.iarc.fr/ Accessed December 2019
- Sante Publique France. Le cancer en France métropolitaine:
projections d’incidence et de mortalité par cancer en 2017
https://www.santepubliquefrance.fr/Actualites/Le-cancer-en-France-metropolitaine-projections-d-incidence-et-de-mortalite-par-cancer-en-2017
Accessed December 2019
- Pennington KP et al. Clin Cancer Res 2014; 20: 764-775
- Konstantinopoulos PA et al. Journal Clin Onco 2010;
22:3555-3561
- 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
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version on businesswire.com: https://www.businesswire.com/news/home/20200203005135/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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