Scientific data describe clinical experience
and potential of Rubraca in multiple solid tumor types
Clovis Oncology, Inc. (NASDAQ: CLVS), announced today that six
abstracts featuring data from clinical and real-world evidence
studies evaluating Rubraca® (rucaparib) in multiple tumor types
have been accepted for presentation or publication at the American
Society of Clinical Oncology 2020 Virtual Scientific Program taking
place May 29 – 31.
The accepted abstracts summarize findings from clinical trials
in which Rubraca was evaluated as a single-agent therapy in ovarian
cancer, metastatic castration-resistant prostate cancer (mCRPC) and
malignant mesothelioma, and in combination with irinotecan in
multiple advanced solid tumors, as well as findings from real-world
evidence studies of the epidemiology and current treatment
landscape of mCRPC.
“We continue to be encouraged by data demonstrating the
potential of Rubraca beyond ovarian cancer and look forward to
sharing new findings from some of the studies exploring its broader
utility and value,” said Patrick J. Mahaffy, President and CEO of
Clovis Oncology. “This year’s virtual ASCO scientific program
provides a timely opportunity to share key clinical updates with
the research and medical community, continuing the important
dialogue around the adoption and utilization of PARP inhibitors
more broadly, and Rubraca in particular.”
The following Clovis-sponsored Rubraca abstract has been
selected for poster discussion and is available now in the ASCO
meeting library.
Abstract Number: 6015, Poster Number: 186 - Characterization
of Patients (pts) with Long-term Responses to Rucaparib in
Recurrent Ovarian Cancer (OC)
- Presenting Author: Elizabeth M. Swisher, MD
- Session: Gynecologic Cancer
The poster and a discussant presentation will be available on
demand by accessing the ASCO meeting library beginning Friday, May
29 at 8:00am EDT. In addition, the poster will be available at
https://www.clovisoncology.com/pipeline/scientific-presentations/
once it becomes available in the ASCO meeting library.
The two following Clovis-sponsored abstracts are available now
in the ASCO meeting library:
Abstract Number: e19319 (online abstract publication) -
Real-world Evidence of Treatment Patterns and Pharmacy Costs Among
Patients with Metastatic Castration-Resistant Prostate Cancer
(mCRPC) in a Managed Care Population in the United States
- Authors: Kelvin A. Moses, MD, PhD, et al.
Abstract Number: e13592 (online abstract publication) -
Epidemiology and Mortality of Metastatic Castration-Resistant
Prostate Cancer (mCRPC) in a Managed Care Population in the United
States
- Authors: Katrine Wallace, PhD, et al.
Additionally, the following three investigator-sponsored
abstracts describing studies of Rubraca have also been selected for
presentation as part of the 2020 ASCO scientific program and are
available now in the ASCO meeting library.
Abstract Number: 3513, Poster Number: 243 - Phase 1 Study of
Rucaparib and Irinotecan in Advanced Solid Tumors with Homologous
Recombination Deficiency (HRD) Mutations
- Presenting Author: Mallika S. Dhawan, MD
- Session: Developmental Therapeutics—Molecularly Targeted Agents
and Tumor Biology
The poster and a discussant presentation will be available on
demand by accessing the ASCO meeting library beginning Friday, May
29 at 8:00am EDT.
Abstract Number: 9057, Poster Number: 250 - MiST1: A Phase
IIa Trial of Rucaparib in Patients Harboring BAP1/BRCA1 Deficient
Relapsed Malignant Mesothelioma
- Presenting Author: Dean A. Fennell, FRCP, PhD
- Session: Lung Cancer—Non-Small Cell Local-Regional/Small
Cell/Other Thoracic Cancers
The poster will be available on demand by accessing the ASCO
meeting library beginning Friday, May 29 at 8:00am EDT.
Abstract Number: TPS6102, Poster Number: 273 - NOGGO
Ov-42/MAMOC: Rucaparib Maintenance After Bevacizumab Maintenance
Following Carboplatin-Based First-Line Chemotherapy in Ovarian
Cancer Patients
- Presenting Author: Elena I. Braicu, MD, PhD
- Session: Gynecologic Cancer
The poster will be available on demand by accessing the ASCO
meeting library beginning Friday, May 29 at 8:00am EDT.
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 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. In TRITON2, MDS/AML was not
observed in patients with mCRPC (n=209) regardless of homologous
recombination deficiency (HRD) mutation.
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%).
Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were
fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT
elevation (33%), decreased appetite (28%), rash (27%), constipation
(27%), thrombocytopenia (25%), vomiting (22%), and diarrhea
(20%).
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, 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 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/20200521005616/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
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