- Findings from the Phase 1b RAMP study evaluating the
combination of Rubraca and Xtandi® (enzalutamide) in men with
unselected mCRPC lay the groundwork for the Phase 3 CASPAR study
which is expected to begin enrolling patients shortly
- Phase 1 data from the RUCA-J study of Rubraca in Japanese
patients with advanced solid tumors show similar safety and
pharmacokinetic profiles to those observed in Western patients
Clovis Oncology, Inc. (NASDAQ: CLVS) announced that Phase 1
clinical data from studies exploring Rubraca in combination with
Xtandi for the treatment of advanced prostate cancer (RAMP) and
Rubraca monotherapy in advanced solid tumors in Japanese patients
(RUCA-J) will be presented during week one of the American
Association for Cancer Research Virtual Annual Meeting (AACR),
taking place April 10-15, 2021.
“We remain committed to understanding how Rubraca may benefit
patients with cancer, and the data presented at AACR further
enhance our understanding in different patient populations and
solid tumor types,” said Patrick J. Mahaffy, President and CEO of
Clovis Oncology. “The Phase 1b RAMP data for the combination of
Rubraca and Xtandi in unselected mCRPC patients help inform the
Alliance for Clinical Oncology-sponsored CASPAR Phase 3 trial which
is expected to begin enrolling patients soon, and we look forward
to learning more about the combination.”
Following are details of the Clovis-sponsored presentations at
AACR 2021:
Poster Presentation 445: Genomic Characteristics and Response
to Rucaparib and Enzalutamide in the Phase 1b RAMP Study of
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Patients
- Lead author: Arpit Rao, MBBS, University of Minnesota,
Minneapolis, USA
- Session: Clinical Research
- Date/Time: April 10, 2021, 8:30 a.m. - 11:59 p.m. ET
- Key Takeaways: The results of this study demonstrated that
unselected patients with mCRPC who had progressed on androgen
receptor (AR)-directed therapies reported declines in
prostate-specific antigen (PSA) following treatment with a
combination of rucaparib 600 mg twice daily and enzalutamide 160 mg
once daily, and these declines were observed even in the presence
of AR alterations and the absence of DNA damage repair gene
alterations. The safety profile was consistent with that associated
with each drug as a monotherapy, with no clinically significant
drug-drug interactions observed with the combination. These data
support further study of the combination in this patient population
and the Phase 3 CASPAR study (Alliance A031902; NCT04455750) is
expected to begin enrolling biomarker-unselected patients with
mCRPC shortly.
Poster Presentation CT124: Evaluation of Rucaparib in
Japanese Patients with a Previously Treated Advanced Solid
Tumor
- Lead author: Kenji Tamura, MD, PhD, National Cancer Center
Hospital, Tokyo, Japan
- Session: Phase I Clinical Trials
- Date/Time: April 10, 2021, 8:30 a.m. - 11:59 p.m. ET
- Key Takeaways: This study suggests rucaparib 600 mg taken twice
daily had a manageable safety profile for Japanese patients with
advanced solid tumors, including ovarian, prostate, endometrial,
and pancreatic cancer. The pharmacokinetic profile of rucaparib in
Japanese patients overlapped with that of Western patients. Among
patients with measurable disease, 18.5% (5/27) achieved an
objective response rate and 51.9% (14/27) had stable disease per
RECIST v1.1. These results support further exploration of rucaparib
600 mg twice daily in Japanese patients.
The presentations can also be viewed at
https://www.clovisoncology.com/pipeline/scientificpresentations/
.
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. Patients should be identified for treatment with
Rubraca based on the presence of a deleterious BRCA mutation
(germline and/or somatic) and selected 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) 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.
About CASPAR Clinical Trial
The CASPAR study is sponsored by the Alliance for Clinical
Trials in Oncology (Alliance A031902; NCT04455750) 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).
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.
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 the potential results of such clinical trials,
our expectations regarding the suitability of Rubraca for certain
patient populations or indications, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210410005008/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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