- ARIEL3 evaluated rucaparib as
maintenance treatment among women with advanced ovarian
cancer
- Study successfully achieved primary,
key secondary and exploratory endpoints
- Company plans to submit a
supplemental New Drug Application (sNDA) in the U.S. for
maintenance treatment indication in ovarian cancer by the end of
October 2017
Clovis Oncology, Inc. (NASDAQ: CLVS) announced that
comprehensive data from the Phase 3 ARIEL3 study of rucaparib for
maintenance treatment of advanced ovarian cancer were published
online today in The Lancet. The ARIEL3 study successfully achieved
its primary and key secondary endpoints - improved progression-free
survival (PFS) by both investigator review and blinded independent
central review (BICR), respectively - in each of the three
populations studied, as well as its exploratory endpoints.
ARIEL3 is a double-blind, placebo-controlled, phase 3 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) tumor BRCA mutant
(tBRCAmut) patients, inclusive of germline and somatic mutations of
BRCA (n=196); 2) HRD patients, including BRCA-mutant patients and
BRCA wild-type with high loss of heterozygosity, or LOH-high
patients (n=354), and, finally, 3) the intent-to-treat population,
or all patients treated in ARIEL3 (n=564). The study achieved its
primary endpoint of improved PFS by investigator review in each of
three populations. PFS was also improved in the rucaparib group
compared with placebo by BICR, a key secondary endpoint, in all
three populations. In addition, rucaparib improved objective
response rate vs placebo among evaluable trial participants in all
three study populations.
“The publication of the ARIEL3 data in this prestigious,
peer-review journal reinforces the importance of identifying new
therapies that provide meaningful clinical benefit to women with
advanced ovarian cancer, and speaks to the high quality of the
study design and the data we were able to deliver,” said Patrick J.
Mahaffy, President and CEO of Clovis Oncology. “We extend our
sincere thanks to the study investigators and authors, as well as
the many patients, who supported and participated in ARIEL3.”
“The extension in PFS in the ARIEL3 intent-to-treat population
demonstrates that patients with platinum-sensitive ovarian
carcinoma can derive robust clinical benefit from rucaparib
maintenance treatment, regardless of their mutational status,” said
Robert L. Coleman, M.D., professor and vice chair, clinical
research, in the Department of Gynecologic Oncology and
Reproductive Medicine at The University of Texas MD Anderson Cancer
Center and the U.S. principal investigator for the ARIEL3 study.
“Additionally, the ARIEL3 study was intentionally designed to
deliver multiple, key insights that will help inform treatment
decisions and management of advanced ovarian cancer patients going
forward.”
According to the paper published today, treatment emergent
adverse events (TEAEs) in the ARIEL3 rucaparib group were generally
managed with dose modifications and not associated with increased
mortality or morbidity compared with the placebo group. Safety data
from ARIEL3 demonstrate consistency with prior rucaparib
studies.
In December 2016, Rubraca® 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, a Marketing Authorization
Application (MAA) was submitted and accepted in Europe for Rubraca
in the same ovarian cancer-treatment indication.
Based on the ARIEL3 findings, Clovis Oncology plans to submit a
supplemental New Drug Application (sNDA) to the U.S. FDA for a
second line or later maintenance treatment indication in ovarian
cancer by the end of October 2017. In early 2018, the Company plans
to file an MAA in Europe for the maintenance treatment indication
upon receipt of a potential approval for the 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. Studies open for enrollment or under
consideration include ovarian, prostate, breast, pancreatic,
gastroesophageal, bladder, lung and urothelial cancers. Clovis is
also developing rucaparib in patients with mutant BRCA tumors and
other DNA repair deficiencies beyond BRCA – commonly referred to as
homologous recombination deficiencies, or HRD. Clovis holds
worldwide rights for rucaparib.
About Ovarian Cancer
Ovarian cancer is the sixth deadliest cancer amongst women in
Europe,i where more than 65,000 women are diagnosed annually.ii
Ovarian cancer is challenging to treat, and most women will relapse
after surgery and chemotherapy. The 80 to 85 percent of women
diagnosed in the later stages of the disease (III and IV) have
particularly poor outcomes.iii Approximately one in four women with
ovarian cancer have a germline or somatic BRCA mutation,iv and new
treatment options are needed to treat unique patient
populations.
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 submission of the sNDA for rucaparib, European
approval of rucaparib for the treatment indication and the filing
of an MAA for a second line or later maintenance indication 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 World Health Organization. Globocan
2012: estimated cancer incidence, mortality and prevalence
worldwide in 2012.
http://globocan.iarc.fr/Pages/fact_sheets_population.aspx
ii Ferlay J, et al. Eur J Cancer 2013;49:1374–1403
iii American Cancer Society. Survival
rates for ovarian cancer, by stage.
https://www.cancer.org/cancer/ovarian-cancer/detection-diagnosis-staging/survival-rates.html
iv Pennington KP, Walsh T, Harrell MI, et al. Germline and somatic
mutations in homologous recombination genes predict platinum
response and survival in ovarian, fallopian tube, and peritoneal
carcinomas. Clin Cancer Res. 2014;20(3):764-775.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170913005364/en/
Clovis Oncology, Inc.Clovis Investor Contacts:Anna
Sussman, 303-625-5022asussman@clovisoncology.comorBreanna Burkart,
303-625-5023bburkart@clovisoncology.comorClovis Media
Contacts:USLisa Guiterman,
301-217-9353clovismedia@sambrown.comorChristy Curran,
615-414-8668clovismedia@sambrown.comorEUAnn Hughes, +44 (0)
7944 168 187Ann.Hughes@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