- Topline data for Rubraca monotherapy arm vs placebo expected 2H
2021; intended to support a supplemental New Drug Application
filing (sNDA)
- Topline data from Rubraca and Opdivo in combination vs Rubraca
monotherapy expected one year or more later
Clovis Oncology, Inc. (NASDAQ: CLVS) announced today the
completion of target patient enrollment in the Clovis-sponsored
Phase 3 ATHENA trial evaluating the combination of Clovis’ Rubraca®
(rucaparib), a poly (ADP ribose) polymerase inhibitor (PARP), and
Bristol-Myers Squibb’s PD-1 inhibitor, OPDIVO® (nivolumab), as
front-line maintenance treatment of newly-diagnosed advanced
ovarian cancer. ATHENA is the first front-line switch maintenance
study designed to show PARP monotherapy and PARP/PD-1 combination
therapy in one study design.
“The completion of target patient enrollment in the Phase 3
ATHENA trial is an important milestone for Clovis and a critical
step toward developing additional therapeutic options for women
with advanced ovarian cancer,” said Patrick J. Mahaffy, President
and Chief Executive Officer of Clovis Oncology. “This was a
tremendous effort by trial investigators, our collaborators and our
dedicated Clovis team to complete target enrollment in this
1,000-patient study in under two years. Most important, we are
grateful to all of the patients who participated in this
study.”
ATHENA is a Phase 3, randomized, multinational, double-blind,
placebo-controlled, four-arm trial evaluating Rubraca and Opdivo as
maintenance treatment following response to front-line treatment in
newly-diagnosed ovarian cancer patients. Response to treatment will
be analyzed based on homologous recombination (HR) status of tumor
samples. The primary endpoint is investigator assessed
progression-free survival (PFS); secondary endpoints include
overall survival (OS), objective response rate (ORR), duration of
response (DOR), and safety.
Target enrollment for the ATHENA trial was 1,000 ovarian cancer
patients. Patients were enrolled at clinical trial centers in 24
countries including North America, Europe and Asia.
Topline data for the Rubraca monotherapy versus placebo arm in
all study populations is expected in the second half of 2021 and,
if supportive, would serve as the basis of an sNDA for the
maintenance treatment of front-line, newly-diagnosed, advanced
ovarian cancer patients. Topline data for the combination of
Rubraca and Opdivo versus Rubraca monotherapy in all study
populations are expected a year or more later and, if supportive,
would serve as the basis of an sNDA for the combination therapy in
front-line, newly-diagnosed ovarian cancer. In each of these, the
primary efficacy analysis will evaluate two prospectively defined
molecular sub-groups in a step-down manner: first, HRD-positive
patients, including BRCA-mutant patients; and the intent-to-treat
population, or all patients treated in ATHENA.
About Rubraca (rucaparib)
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and
PARP3 being developed in ovarian cancer as well as several
additional solid tumor indications. Studies open for enrollment or
under consideration include ovarian, prostate, breast,
gastroesophageal, pancreatic, and lung cancers. Clovis holds
worldwide rights for Rubraca.
In the United States, Rubraca is approved for the maintenance
treatment of adult patients with recurrent epithelial ovarian,
fallopian tube, or primary peritoneal cancer who are in a complete
or partial response to platinum-based chemotherapy. Rubraca is also
approved in the United States for the treatment of adult patients
with 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 and selected
for therapy based on an FDA-approved companion diagnostic for
Rubraca. Additionally, 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.
In Europe, Rubraca is approved for the maintenance treatment of
adults with platinum-sensitive relapsed high-grade epithelial
ovarian, fallopian tube, or primary peritoneal cancer who are in
response (complete or partial) to platinum-based chemotherapy.
Rubraca is also approved in Europe for the treatment of adult
patients with platinum sensitive, relapsed or progressive, BRCA
mutated (germline and/or somatic), high-grade epithelial ovarian,
fallopian tube, or primary peritoneal cancer, who have been treated
with two or more prior lines of platinum-based chemotherapy, and
who are unable to tolerate further platinum-based chemotherapy.
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.
Rubraca is an unlicensed medical product outside of the U.S. and
Europe.
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.
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, our expectations regarding the
timing and pace of conduct of our clinical trials, including those
being planned or conducted in collaboration with partners, the
potential results of such clinical trials, our plans for submission
of regulatory filings, and our plans to present data on ongoing
clinical trials. 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 impacts of the
COVID-19 pandemic and disruption on our ability to continue our
development activities, impacts on the conduct of our clinical
trials, including with respect to availability of investigators and
clinical trial sites or monitoring of data, whether our clinical
development programs for our drug candidates and those of our
partners can be completed on time or at all, the timing of
availability of data from our clinical trials and the results,
actions by the FDA, the EMA or other regulatory authorities
regarding data required to support drug applications and whether to
accept or approve drug applications that may be filed, their
interpretations of our data and agreement with our regulatory
approval strategies or components of our filings, including our
clinical trial designs, conduct and methodologies, as well as their
decisions regarding drug labeling, reimbursement and pricing, and
other matters that could affect the development, approval,
availability or commercial potential of our drug candidates or
companion diagnostics. 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
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200610005746/en/
Clovis Oncology Investor Contacts: Anna Sussman,
303-625-5022 asussman@clovisoncology.com or Breanna Burkart,
303-625-5023 bburkart@clovisoncology.com Clovis Oncology Media
Contacts: U.S. Lisa Guiterman, 301-217-9353
clovismedia@sambrown.com Europe Jake Davis, +44 (0)
203.946.3538 Jake.Davis@publicisresolute.com or Joanna Sullivan,
+44 (0) 207.173.4191 Joanna.Sullivan@publicisresolute.com
Clovis Oncology (NASDAQ:CLVS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Clovis Oncology (NASDAQ:CLVS)
Historical Stock Chart
From Apr 2023 to Apr 2024