- 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 reimbursed in several countries in Europe with
additional countries to follow in 2020
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that the
Italian Medicines Agency (AIFA) has approved rucaparib for
reimbursement in Italy. Rucaparib will soon be available as 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.3
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.3
“We very much welcome the arrival of the PARP inhibitor
rucaparib, which offers a new treatment option after surgery and
two lines of chemotherapy to all eligible women affected by
relapsed ovarian cancer,” declared Nicoletta Cerana, National
President of Acto Onlus, the number one Italian network of patient
associations involved in the fight against ovarian cancer and
gynecological tumors. “Ovarian cancer is a highly lethal neoplasm
which now, thanks to the PARP inhibitors, can finally be made
chronic. Patients know this and are ready to embark upon the
difficult journey towards chronicity. As an association, we
therefore hope that rucaparib can be prescribed as soon as possible
in all Italian regions.”
Approximately 5,000 women are diagnosed with ovarian cancer in
Italy every year, which equates to roughly 14 every day, and
accounts for about 30 percent of all malignant tumors of the female
reproductive system.4,5 In addition, approximately 25 percent of
patients harbor a BRCA1/2 mutation correlating to responsiveness to
therapy, while the majority of women who are diagnosed are BRCA
wild-type will have a worse prognosis and limited therapeutic
options.5,6,7 Despite advancements in treatment and care, more than
3,000 women still die each year.4 The 5-year survival rate for
ovarian cancer in Italy is only 39 percent, falling to 31 percent
at 10 years.5 Of those treated with surgery and first line
chemotherapy, approximately 70 percent of patients will relapse
within the first three years.8
“On a personal level, I am very pleased to be able to offer
rucaparib to Italian patients as well, as this represents an
important innovation,” said Nicoletta Colombo, Director of the
Oncological Gynecology Program of the European Institute of
Oncology in Milan and Associate Professor at the University of
Milano-Bicocca. “In the ARIEL3 study, in fact, rucaparib doubled
disease-free time after a second line of chemotherapy compared to
placebo and with a manageable tolerability profile despite a study
population very similar to clinical practice, regardless of the
BRCA mutation.”
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
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
“In ovarian cancer, around 80 percent of cases involve women
without a BRCA mutation and are characterized by a particularly
poor prognosis,” explains Professor Sandro Pignata, Director of
Medical Oncology of the Urogynecology Department at the National
Oncological Institute Pascale Foundation cancer center in Naples,
Scientific Coordinator of the Campania Region Oncology Network and
President of the MITO Research Group. “The fact that rucaparib is a
reimbursable drug makes it an important new treatment option, even
for these patients who still too often do not receive safe and
effective maintenance therapy.”
“The reimbursement of Rubraca in Italy is an important step in
the ovarian cancer treatment pathway, as it has shown to be
effective across a broad population of women with relapsed ovarian
cancer,” said Patrick J. Mahaffy, President and CEO of Clovis
Oncology. “We are working to make Rubraca available to as many
eligible patients as possible across Europe, and we look forward to
additional country launches in the coming months.”
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
≥2prior 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.
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
≥2prior 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 Italy, 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 October 2019.
- GU Serie Generale n.265 del 12-11-2019
- World Health Organization. GLOBOCAN: estimated cancer
incidence, mortality and prevalence worldwide in 2018. Available at
http://gco.iarc.fr/. Accessed October 2019.
- AIRTUM / AIOM Ovarian Cancer Guidelines.
https://www.aiom.it/wp-content/uploads/2018/11/2018_LG_AIOM_Ovaio.pdf.
Accessed October 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/20191113005122/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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