Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that two
abstracts featuring data from clinical studies evaluating Rubraca®
(rucaparib) in metastatic castration-resistant prostate cancer
(mCRPC) and one abstract describing adverse events associated with
mCRPC treatment based on real world evidence have been accepted for
poster presentation at the American Society of Clinical Oncology
(ASCO) 2021 Genitourinary Cancers Symposium to be held virtually,
February 11-13, 2021.
“These data underscore our continued commitment to fully
understanding the clinical role of Rubraca and to accelerating the
delivery of transformative therapies to the advanced prostate
cancer community,” said Patrick J. Mahaffy, President and CEO of
Clovis Oncology. “The data that will be shared add to growing
scientific knowledge about the science of mCRPC and broaden our
understanding of Rubraca as a treatment option for patients
diagnosed with mCRPC.”
The following Clovis-sponsored abstracts will be available on
February 8 at 5:00 pm ET and will also be available as posters for
viewing starting February 11 at 8:00 am ET on ASCO's Meeting
Library. The posters can also be viewed at
https://www.clovisoncology.com/pipeline/scientific-presentations/
starting February 11 at 8:00 am ET.
Abstract Number 80: Association of co-occurring gene
alterations and clinical activity of rucaparib in patients with
BRCA1 or BRCA2 mutated (BRCA+) metastatic castration-resistant
prostate cancer (mCRPC)
- Poster Session: Prostate Cancer - Advanced Disease
- Date/Time: Thursday, February 11 at 8:00 am ET
- Lead Author: Wassim Abida, MD, PhD, Memorial Sloan Kettering
Cancer Center, New York, New York
Abstract Number 79: Rucaparib plus enzalutamide in patients
(pts) with metastatic castration-resistant prostate cancer (mCRPC):
Pharmacokinetics (PK) and safety data from the phase 1b RAMP
study
- Poster Session: Prostate Cancer - Advanced Disease
- Date/Time: Thursday, February 11 at 8:00 am ET
- Lead Author: Arpit Rao, MBBS, University of Minnesota Medical
School, Minneapolis, Minnesota
Abstract Number 61: Clinically significant events associated
with metastatic castration-resistant prostate cancer (mCRPC)
treatments
- Poster Session: Prostate Cancer - Advanced Disease
- Date/Time: Thursday, February 11 at 8:00 am ET
- Lead Author: Kelvin A. Moses, MD, PhD, FACS, Vanderbilt
University Medical Center, Nashville, Tennessee
About Rubraca (rucaparib)
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and
PARP3 being developed multiple tumor types, including ovarian and
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 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. Select patients for therapy based on an
FDA-approved companion diagnostic for Rubraca.
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,
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, and has additional
offices in the U.S. and Europe. Please visit 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/20210204005249/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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