Clovis Oncology, Inc. (NASDAQ: CLVS) today announced the
presentation of data from the TRITON3 Phase 3 trial in men with
metastatic castration-resistant prostate cancer with BRCA or ATM
mutations. The presentation titled, “TRITON3: A Phase 3 Study of
Rucaparib vs. Physician’s Choice of Therapy in mCRPC Associated
with Homologous Recombination Deficiency (HRD)” is being presented
by Alan H. Bryce, MD, chair of the Division of Hematology and
Medical Oncology at the Mayo Clinic and co-principal investigator
of the TRITON3 trial during the session titled, “Novel Clinical
Trial Updates” at the 29th Annual Prostate Cancer Foundation (PCF)
Scientific Retreat.
The presentation is available at
https://clovisoncology.com/pipeline/scientific-presentations/.
“We believe that the positive results from TRITON3 further
demonstrate the important role that Rubraca may play as a treatment
option for men with metastatic castration-resistant prostate cancer
associated with homologous recombination deficiency. This is the
first and only PARP inhibitor that has demonstrated superior
radiographic PFS compared to a control arm containing docetaxel
chemotherapy, which is today the standard of care for these
patients,” said Patrick J. Mahaffy, President and CEO of Clovis
Oncology. “We look forward to submitting additional data for
presentation during a medical meeting in 2023.”
Earlier this month, the Company reported top-line data from the
TRITON3 (NCT02975934) study evaluating Rubraca monotherapy versus
chemotherapy or second-line second-generation androgen pathway
inhibitor in patients with chemotherapy-naive mCRPC with mutations
in BRCA or ATM achieved the primary endpoint of improved
radiographic progression-free survival (rPFS) by independent
radiology review (IRR).
About the TRITON3 Clinical Trial
TRITON3 (NCT02975934) is a Phase 3, multicenter, open-label,
randomized trial of Rubraca in patients with chemotherapy-naïve
mCRPC. Patients with a mutation in BRCA or ATM were randomized to
Rubraca or the control group, which consisted of physician’s choice
of docetaxel, abiraterone acetate, or enzalutamide. The primary
objective was efficacy, as analyzed by independent radiology review
(IRR) of radiographic progression-free survival (rPFS) in patients
with mutations in BRCA1, BRCA2 or ATM. TRITON3 was designed as a
Phase 3 trial to confirm and expand the efficacy data from TRITON2
in an earlier treatment setting against a relevant control arm.
About Prostate Cancer
The American Cancer Society estimates that approximately 268,000
men in the US will be diagnosed with prostate cancer in 2022, and
the GLOBOCAN Cancer Fact Sheets estimated that approximately
473,000 men in Europe were diagnosed with prostate cancer in 2020.
Castrate-resistant prostate cancer has a high likelihood of
developing metastases. Metastatic castrate-resistant prostate
cancer (mCRPC) is an incurable disease, usually associated with
poor prognosis.i Approximately 43,000 men in the US were expected
to be diagnosed with mCRPC in 2020.ii According to the National
Cancer Institute, the five-year survival rate for mCRPC is
approximately 30%. BRCA1, BRCA2 or ATM mutations have been detected
in approximately 19% of patients with mCRPC according to articles
published in JCO Precision Oncology in 2017 and in Clinical Cancer
Research in 2021. These molecular markers may be used to select
patients for treatment with a PARP inhibitor.iii
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.
Rubraca is an unlicensed medical product outside of the US and
Europe.
Rubraca US 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.
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) have
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 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 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.
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 US, 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 US 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 made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Examples of forward-looking statements contained in this press
release include, among others, statements regarding our
expectations concerning future regulatory activities, expectations
for submission of regulatory filings, our plans to present final or
interim data on ongoing clinical trials, our plans to submit
additional data to, or meet with, the FDA with respect to the
status of or plans for ongoing or planned trials, the potential for
marketing authorizations for new indications, our expectations
regarding the suitability of Rubraca, 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, including that of secondary endpoints such
as overall survival, and the maturity of such data, 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.
i Sumanasuriya S. and Bono J., Treatment of Advanced Prostate
Cancer—A Review of Current Therapies and Future Promise, Cold
Spring Harb Perspect Med, 2018, June; 8(6); a030635.
ii Scher H. et al, Prevalence of Prostate Cancer Clinical States
and Mortality in the United States: Estimates Using a Dynamic
Progression Model, PLoS One, 2015; 10(10)
iii Congregado B., PARP Inhibitors: A New Horizon for Patients
with Prostate Cancer, Biomedicines, 2022 Jun; 10 (6)
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Clovis Investor Contact:
investorinquiries@clovisoncology.com
Clovis Media Contact: clovismedia@clovisoncology.com
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