- Filing based on positive phase 3
ARIEL3 clinical trial in which rucaparib significantly improved PFS
in all ovarian cancer patient populations studied
- Company plans to file Marketing
Authorization Application in Europe in early 2018 for maintenance
treatment indication
Clovis Oncology (NASDAQ: CLVS) announced today that the company
has submitted a supplemental New Drug Application (sNDA) to the
U.S. Food and Drug Administration (FDA) for rucaparib as
maintenance treatment of patients with recurrent epithelial
ovarian, fallopian tube, or primary peritoneal cancer who are in a
complete or partial response to platinum-based chemotherapy. The
sNDA submission is based on data from the phase 3 ARIEL3 clinical
trial, which found that rucaparib significantly improved
progression-free survival in all ovarian cancer patient populations
studied.
“The submission of the sNDA for rucaparib in the ovarian cancer
maintenance setting just four months after we reported topline
results marks an important milestone that brings Clovis closer to
our ultimate goal of making rucaparib available to a broader
population of women with advanced ovarian cancer,” said Patrick J.
Mahaffy, President and CEO of Clovis Oncology. “We believe that the
ARIEL3 results demonstrate the potential of rucaparib to provide a
new, much-needed therapeutic option for women with advanced ovarian
cancer.”
The phase 3 ARIEL3 clinical trial forms the basis of the
rucaparib sNDA. ARIEL3 is a double-blind, placebo-controlled trial
of rucaparib that enrolled 564 women with platinum-sensitive,
high-grade ovarian, fallopian tube, or primary peritoneal cancer.
The primary efficacy analysis evaluated three prospectively defined
molecular sub-groups in a step-down manner: 1) BRCA mutant; 2)
HRD-positive; and finally, 3) the intent-to-treat population, or
all patients treated in ARIEL3.
Clovis announced positive topline results from the ARIEL3
clinical trial in June 2017. The comprehensive dataset from the
trial was presented at the 2017 European Society for Medical
Oncology (ESMO) Annual Conference in Madrid, Spain,i and
subsequently published in The Lancet.ii
Clovis intends to file a Marketing Authorization Application
(MAA) in Europe in early 2018 for the maintenance indication, upon
receipt of a potential approval in Europe for the ovarian cancer
treatment indication.
About the ARIEL3 Clinical Trial
The ARIEL3 pivotal study of rucaparib is a confirmatory
randomized, double-blind study comparing the effects of rucaparib
against placebo to evaluate whether rucaparib given as a
maintenance treatment to platinum-sensitive ovarian cancer patients
can extend the period of time for which the disease is controlled
after a complete or partial response to platinum-based
chemotherapy. The study enrolled 564 patients with high-grade
epithelial ovarian, fallopian tube or primary peritoneal cancer. To
be eligible for the study, participants had to have received at
least two prior platinum-based treatment regimens, been sensitive
to the penultimate platinum regimen, and achieved a complete or
partial response to their most recent platinum-based regimen. There
were no genomic selection criteria for this study. Trial
participants were randomized 2:1 to receive 600 milligrams of
rucaparib twice daily (BID) or placebo.
About Rucaparib
Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2
and PARP3 being developed in ovarian cancer as well as several
additional solid tumor indications. In December 2016, rucaparib
became the first PARP inhibitor approved by the U.S. Food and Drug
Administration (FDA) as monotherapy for treatment of patients with
deleterious BRCA mutation (germline and/or somatic) associated
advanced ovarian cancer who have been treated with two or more
prior chemotherapies. During the fourth quarter of 2016, the
Marketing Authorization Application (MAA) submission in Europe for
rucaparib in the same ovarian cancer treatment indication was
submitted and accepted for review. In October 2017, Clovis Oncology
submitted a supplemental New Drug Application (sNDA) in the U.S.
for a second line or later maintenance treatment indication in
ovarian cancer based on the ARIEL3 data, and in early 2018, plans
to file an MAA in Europe for the maintenance treatment indication
upon receipt of a potential approval for the treatment indication.
Ongoing studies include the TRITON2 and TRITON3 (Trial of Rucaparib
In Prostate Indications) studies in metastatic castration-resistant
prostate cancer (mCRPC), the ARIEL4 (Assessment of Rucaparib in
Ovarian Cancer Trial) confirmatory study in relapsed ovarian cancer
patient with BRCA mutations, and the ATHENA (A Multicenter,
Randomized, Double-Blind, Placebo-Controlled study
of nivolumab and rucaparib Combination Switch Maintenance
Following Front-Line Platinum-based Chemotherapy in Ovarian Cancer
Patients) study is expected to begin before the end of 2017.
Exploratory studies in other tumor types are also underway. Clovis
holds worldwide rights for rucaparib.
About Ovarian Cancer
According to the American Cancer Society, more than 22,400 women
will be diagnosed with ovarian cancer in the U.S. in 2017. There
are often no clearly identifiable initial symptoms, and in an
estimated 80 to 85% of ovarian cancer cases, the cancer has spread
to other parts of the body before a person is diagnosed and can be
treated. Ovarian cancer ranks fifth in cancer deaths and causes
more deaths than any other cancer of the female reproductive
system.
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 San Francisco, California and Cambridge, UK. 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 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 expectation
of timing for review and approval of the sNDA and submission,
review and approval of the MAAs for rucaparib. 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 the clinical
development programs for our drug candidates, including the result
of clinical trials, whether future study results will be consistent
with study findings to-date, the corresponding development pathways
of our companion diagnostics, the timing of availability of data
from our clinical trials and the results of our clinical trials,
the initiation, enrollment and timing of our planned clinical
trials, actions by the FDA, the EMA or other regulatory
authorities regarding whether to approve drug applications that may
be filed, as well as their decisions that may affect drug labeling,
pricing and reimbursement, and other matters that could affect the
availability or commercial potential of our drug candidates or
companion diagnostics. 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 Ledermann, J., MD. ARIEL3: A phase 3, randomised, double-blind
study of rucaparib vs placebo following response to platinum-based
chemotherapy for recurrent ovarian carcinoma (OC). Presented at
2017 European Society for Medical Oncology Congress in Spain,
Madrid. 8 September 2017.ii Coleman R, et al. Rucaparib maintenance
treatment for recurrent ovarian carcinoma after response to
platinum therapy (ARIEL3): a randomised, double-blind,
placebo-controlled, phase 3 trial. The Lancet. 12 September 2017.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)32440-6/fulltext
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171009005809/en/
Clovis Oncology, Inc.Clovis Investor Contacts:Anna
Sussman, 303-625-5022asussman@clovisoncology.comorBreanna Burkart,
303-625-5023bburkart@clovisoncology.comorClovis Media
Contacts:Lisa Guiterman,
301-217-9353clovismedia@sambrown.comorChristy Curran,
615-414-8668clovismedia@sambrown.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