- Findings from Phase 1b RAMP clinical trial lay the groundwork
for Phase 3 CASPAR clinical trial evaluating Rubraca® (rucaparib)
and Xtandi® (enzalutamide) in combination which is expected to
begin enrolling patients shortly
- Exploratory analyses from the Phase 2 TRITON2 study demonstrate
the efficacy of Rubraca in men with BRCA-mutated mCRPC despite the
presence of co-occurring gene alterations in certain
tumor-suppressor genes that are associated with poor prognosis
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced Rubraca
data being presented at the American Society for Clinical Oncology
(ASCO) Genitourinary Cancers Virtual Symposium 2021. These include
data from the Phase 1b RAMP study evaluating Rubraca in combination
with Xtandi, exploratory analyses from the pivotal TRITON2 study,
and an analysis evaluating the rates of adverse events for
different metastatic castration-resistant prostate cancer (mCRPC)
treatments in a population of insured patients in the United
States.
“We are pleased to share these data with the medical and
scientific community to inform choices related to mCRPC treatment.
The research into co-occurring alterations in mCRPC patients with a
mutation of BRCA underscores the importance of genomic testing in
men with mCRPC,” said Patrick J. Mahaffy, President and CEO of
Clovis Oncology. “Additionally, we are encouraged by the results
from the RAMP study, which lay the groundwork for the Phase 3
CASPAR clinical trial sponsored by the Alliance for Clinical Trials
in Oncology evaluating Rubraca and Xtandi as a novel combination
therapy in men with first-line metastatic castration-resistant
prostate cancer.”
Data from the RAMP study are presented by Arpit Rao, MD,
Assistant Professor, Hematology, Oncology and Transplantation at
the University of Minnesota. This Phase 1b study is investigating
the combination of Rubraca and Xtandi in biomarker-unselected
(including BRCA1/2 mutation negative) patients with mCRPC to assess
the pharmacokinetics (PK) and safety of the combination. Treatment
with rucaparib and enzalutamide had no clinically significant
effect on the PK profiles of either drug, and the safety profile of
the combination was consistent with that associated with each drug
as monotherapy. The results presented at ASCO GU show that this
combination is well-tolerated and without any significant drug-drug
interactions. Data from the RAMP study support the randomized,
placebo-controlled Phase 3 CASPAR study (Alliance A031902;
NCT04455750) that is studying Rubraca and Xtandi, and is the
subject of a Trial in Progress (TiP) poster being presented at the
ASCO GU meeting. It is expected to begin enrolling mCRPC patients
shortly.
The CASPAR study is sponsored by the Alliance for Clinical
Trials in Oncology and will enroll approximately 1,000 patients in
the United States. It is expected to open at hundreds of National
Clinical Trials Network (NCTN) sites nationally. This is the only
combination trial of a PARP inhibitor and novel anti-androgen with
an overall survival co-primary endpoint. Patients who have received
prior abiraterone/apalutamide in a non-mCRPC setting are allowed to
enroll to maximize applicability in the era of rapidly changing
standards-of-care. The Alliance is part of the NCTN sponsored by
the National Cancer Institute (NCI).
Data from the TRITON2 clinical trial are presented by Wassim
Abida MD, PhD at Memorial Sloan Kettering Cancer Center. These data
underscore the antitumor activity of Rubraca among men with
BRCA-mutated mCRPC and commonly co-occurring genomic alterations.
Alterations in tumor suppressor genes, including TP53, PTEN and
RB1, are associated with poor prognosis in patients with prostate
cancer. Results from TRITON2 showed antitumor activity for Rubraca
in patients with BRCA-mutated mCRPC associated with or without
co-occurring alterations in these genes. There was no clear
difference in radiographic and PSA response rates for patients with
or without co-occurring TP53, PTEN, or RB1 alterations. Based on
these results, researchers concluded that patients with mCRPC
associated with a BRCA alteration should be considered for
treatment with rucaparib irrespective of the presence of
co-occurring alterations in these tumor suppressor genes.
In addition, data from an analysis of clinically significant
events (CSEs) associated with mCRPC treatments were presented by
Kelvin A. Moses, MD, PhD, Associate Professor of Urology at
Vanderbilt University Medical Center. Researchers designed the
analysis to better understand the association between mCRPC
treatments and development of CSEs in a population of insured
patients in the United States. Using an administrative claims
database for the period from January 2008 to March 2019, the
analysis found that among available mCRPC treatments,
chemotherapy-based regimens had the highest CSE rates per treatment
year. These data indicate the burden of treatment for patients and
can inform treatment decisions.
Clovis Oncology-sponsored e-posters are available online at
www.clovisoncology.com/pipeline/scientific-presentations.
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 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.
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.
About Alliance for Clinical Trials in Oncology
The Alliance for Clinical Trials in Oncology develops and
conducts clinical trials with promising new cancer therapies, and
utilizes the best science to develop optimal treatment and
prevention strategies for cancer, as well as research methods to
alleviate side effects of cancer and cancer treatments. The
Alliance is part of the National Clinical Trials Network (NCTN)
sponsored by the National Cancer Institute (NCI) and serves as a
research base for the NCI Community Research Oncology Program
(NCORP). The Alliance comprises nearly 10,000 cancer specialists at
hospitals, medical centers, and community clinics across the United
States and Canada. Learn more about the Alliance, visit
www.AllianceforClinicalTrialsinOncology.org.
Clovis Oncology Forward-Looking Statement
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 the timing and pace of
commencement of and enrollment in clinical trials, including those
not sponsored by us, 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, and our expectations regarding the outcomes of early studies
or trials supporting further development, both non-clinical and
clinical. 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/20210211005218/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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