Clovis Oncology, Inc. (NASDAQ: CLVS), announced today that data
from the Phase 2 TRITON2 study of Rubraca® (rucaparib) for the
treatment of metastatic castration-resistant prostate cancer
(mCRPC) harboring BRCA1/2 mutations were published online in the
Journal of Clinical Oncology. These results supported the May 2020
U.S. Food and Drug Administration (FDA) accelerated approval of
Rubraca for the treatment of mCRPC patients who have a deleterious
BRCA mutation (germline and/or somatic) and who have previously
received androgen receptor-directed therapy and taxane-based
chemotherapy.
“Through publication in this prestigious journal, we are pleased
to be able to share more detail about this important study, which
we believe will be helpful for physicians as they consider
treatment options for their mCRPC patients,” said Patrick J.
Mahaffy, President and CEO of Clovis Oncology. “The TRITON2 data
underscore Rubraca’s role as a meaningful new treatment option for
men with mCRPC and a deleterious germline or somatic BRCA mutation
who have progressed on androgen receptor-directed therapy and
taxane-based chemotherapy.”
The publication, titled Rucaparib in Men
with Metastatic Castration-resistant Prostate Cancer Harboring a
BRCA1 or BRCA2 Gene Alteration, is available online at
https://ascopubs.org/journal/jco/ and can be accessed by clicking
here.
“PARP inhibitors have been a welcome additional treatment option
available for eligible mCRPC patients, and I’m pleased that this
publication provides additional detail about the potential clinical
benefit of Rubraca for patients,” said Wassim Abida, M.D., Medical
Oncologist, Memorial Sloan Kettering Cancer Center, and principal
investigator for the TRITON2 study. “These additional data
presented in this publication provide physicians important
information to inform treatment decisions for their eligible
patients.”
Dr. Abida has provided advisory services for Clovis.
About Rubraca (rucaparib)
Rubraca 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. Clovis
holds worldwide rights for Rubraca.
Rubraca is an unlicensed medical product outside of the U.S. and
Europe.
Rubraca U.S. FDA Approved mCRPC Indication
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) has
occurred 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 findings in genetic toxicity and animal reproduction
studies, advise male patients with female partners of reproductive
potential or who are pregnant to use effective methods of
contraception during treatment and for 3 months following last dose
of Rubraca. Advise male patients not to donate sperm during therapy
and for 3 months following the last dose of Rubraca.
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.
Click here for full Prescribing Information for Rubraca.
You may also report side effects to Clovis Oncology, Inc. at
1-415-409-7220 (US toll) or 1-844-CLVS-ONC (1-844-258-7662; US
toll-free).
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.
This press release contains forward-looking statements (as
defined under the Private Securities Litigation Reform Act of 1995)
about the potential of Rubraca® (rucaparib) for the treatment of
adult patients with 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, and reflects Clovis
Oncology’s current beliefs. As with any pharmaceutical product,
there are substantial risks and uncertainties in the process of
development and commercialization that could cause actual results
to differ materially from those expressed or implied by the
forward-looking statements. In particular, there are no guarantees
that future study results and patient experience will be consistent
with the study findings to date, that Rubraca will receive
regulatory approval for any future indications, or that it will
prove to be commercially successful. 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. All
forward-looking statements are based on information currently
available to the company, and Clovis Oncology does not undertake to
update or revise any forward-looking statements
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version on businesswire.com: https://www.businesswire.com/news/home/20200817005082/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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