Accepted abstract describes exploratory
analysis from ARIEL3 further suggesting the durable clinical
benefit of Rubraca maintenance treatment beyond progression for
women with platinum-sensitive recurrent ovarian cancer with BRCA1/2
mutations
Clovis Oncology, Inc. (NASDAQ: CLVS), announced today that an
abstract featuring data from an exploratory analysis of the ARIEL3
clinical study evaluating Rubraca® (rucaparib) as maintenance
treatment in recurrent ovarian cancer has been accepted for
presentation in an oral plenary session at the International
Gynecologic Cancer Society (IGCS) Digital Annual Global Meeting
taking place September 10–13. The findings of the analysis
demonstrate that rucaparib maintenance treatment can lead to a
clinically meaningful delay in starting subsequent therapy and
lasting clinical benefits in patients with BRCA1- or BRCA2-mutant
ovarian cancer.
“This exploratory analysis examining the subgroup of patients
with advanced recurrent ovarian cancer and a BRCA1 or BRCA2
mutation suggest the durability of the clinical benefit of
rucaparib maintenance,” said Johanne Weberpals M.D., Gynecologic
Oncologist, Ottawa Hospital Research Institute. “These data
reinforce the potential benefit of rucaparib in this patient
population.”
“Together with ARIEL3 results we have previously published and
presented, these data highlight the clinical benefit that Rubraca
offers as a maintenance therapy for patients with recurrent ovarian
cancer,” said Patrick J. Mahaffy, President and CEO of Clovis
Oncology. “We look forward to sharing these data with the research
and medical community at this year’s digital IGCS global meeting
and continuing the important dialogue around the benefits of
Rubraca for the treatment of advanced ovarian cancer.”
Following are details regarding the Rubraca abstract to be
presented today at IGCS:
Abstract Number: IGCS20_1268- Postprogression Efficacy
Outcomes from the Phase 3 ARIEL3 Study of Rucaparib in Patients
With Platinum-Sensitive Recurrent Ovarian Carcinoma Associated With
Either BRCA1 or BRCA2 Mutations
- Presenting Author: Johanne I. Weberpals, MD
- Session: Plenary I
The presentation will take place during the Plenary I session
which will be broadcast on Thursday, September 10, 2020 from
14:00-15:00 UTC; the specific presentation time is 14:47-14:54 UTC.
In addition, the presentation will be available at
https://www.clovisoncology.com/pipeline/scientific-presentations/
following the Plenary I session.
About Rubraca (rucaparib)
Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2
and PARP3 being developed in multiple tumor types, including
ovarian and metastatic castration-resistant prostate cancers, as
monotherapy, and in combination with other anti-cancer agents.
Exploratory studies in other tumor types are also underway.
Rubraca is an unlicensed medical product outside of the U.S. and
Europe.
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.
Rubraca U.S. FDA Approved Indications
Ovarian Cancer
Rubraca is indicated for the maintenance treatment of adult
women with recurrent epithelial ovarian, fallopian tube, or primary
peritoneal cancer who are in a complete or partial response to
platinum-based chemotherapy.
Rubraca is indicated for the treatment of adult women with a
deleterious BRCA mutation (germline and/or somatic)-associated
epithelial ovarian, fallopian tube, or primary peritoneal cancer
who have been treated with two or more chemotherapies. Select
patients for therapy based on an FDA-approved companion diagnostic
for Rubraca.
Prostate Cancer
Rubraca is indicated for the treatment of adult patients with a
deleterious BRCA mutation (germline and/or somatic)-associated
metastatic castration-resistant prostate cancer (mCRPC) who have
been treated with androgen receptor-directed therapy and a
taxane-based chemotherapy. This indication is approved under
accelerated approval based on objective response rate and duration
of response. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
confirmatory trials.
Select Important Safety Information
Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML)
occur in patients treated with Rubraca, and are potentially fatal
adverse reactions. In 1146 treated patients, MDS/AML occurred in 20
patients (1.7%), including those in long term follow-up. Of these,
8 occurred during treatment or during the 28 day safety follow-up
(0.7%). The duration of Rubraca treatment prior to the diagnosis of
MDS/AML ranged from 1 month to approximately 53 months. The cases
were typical of secondary MDS/cancer therapy-related AML; in all
cases, patients had received previous platinum-containing regimens
and/or other DNA damaging agents.
Do not start Rubraca until patients have recovered from
hematological toxicity caused by previous chemotherapy (≤ Grade 1).
Monitor complete blood counts for cytopenia at baseline and monthly
thereafter for clinically significant changes during treatment. For
prolonged hematological toxicities (> 4 weeks), interrupt
Rubraca or reduce dose and monitor blood counts weekly until
recovery. If the levels have not recovered to Grade 1 or less after
4 weeks or if MDS/AML is suspected, refer the patient to a
hematologist for further investigations, including bone marrow
analysis and blood sample for cytogenetics. If MDS/AML is
confirmed, discontinue Rubraca.
Based on its mechanism of action and findings from animal
studies, Rubraca can cause fetal harm when administered to a
pregnant woman. Apprise pregnant women of the potential risk to a
fetus. Advise females of reproductive potential to use effective
contraception during treatment and for 6 months following the last
dose of Rubraca. For males on Rubraca treatment who have female
partners of reproductive potential or who are pregnant, effective
contraception should be used during treatment and for 3 months
following the last dose of Rubraca.
Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1-4) were
nausea (76%), fatigue/asthenia (73%), abdominal pain/distention
(46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation
(38%), constipation (37%), vomiting (37%), diarrhea (32%),
thrombocytopenia (29%), nasopharyngitis/upper respiratory tract
infection (29%), stomatitis (28%), decreased appetite (23%), and
neutropenia (20%).
Most common adverse reactions in Study 10 and ARIEL2 (≥ 20%;
Grade 1-4) were nausea (77%), asthenia/fatigue (77%), vomiting
(46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased
appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea
(21%), and thrombocytopenia (21%).
Co-administration of rucaparib can increase the systemic
exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may
increase the risk of toxicities of these drugs. Adjust dosage of
CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically
indicated. If co-administration with warfarin (a CYP2C9 substrate)
cannot be avoided, consider increasing frequency of international
normalized ratio (INR) monitoring.
Because of the potential for serious adverse reactions in
breast-fed children from Rubraca, advise lactating women not to
breastfeed during treatment with Rubraca and for 2 weeks after the
last dose.
Please click here for full
Prescribing Information for Rubraca.
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 expectations for submission of regulatory
filings, the timing and pace of commencement of and enrollment in
our clinical trials, including those being planned or conducted in
collaboration with partners, the potential results of such clinical
trials, our expectations regarding the suitability of Rubraca for,
and our plans to develop Rubraca in, additional indications and
tumor types. 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, whether future study results will be
consistent with study findings to date, the timing of availability
of data from our clinical trials and the initiation, enrollment,
timing and results of our planned clinical trials and the
corresponding development pathways, effectiveness and suitability
of diagnostic tests, the risk that final results of ongoing trials
may differ from initial or interim results as a result of factors
such as final results from a larger patient population may be
different from initial or interim results from a smaller patient
population, the risk that additional pre-clinical or clinical
studies may not support further development in certain additional
indications or tumor types, and actions by the FDA, the EMA or
other regulatory authorities regarding data required to support
drug applications and whether to approve drug applications. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200910005188/en/
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
Europe 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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