Market Overview

Rubraca® (rucaparib) Approved in the U.S. as Maintenance Treatment of Recurrent Ovarian Cancer

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  • Rubraca is now indicated as maintenance treatment for women with
    recurrent ovarian cancer who are in a complete or partial response to
    platinum-based chemotherapy, regardless of BRCA mutation status – no
    biomarker testing required
  • Rubraca received regular approval in this broader and earlier-line
    indication based on positive data from the phase 3 ARIEL3 clinical
    trial
  • Rubraca provided statistically-significant improvement in
    progression-free survival versus placebo in all patients studied
    (median 10.8 mos v. 5.4 mos) by investigator assessment
  • Most common Grade 3-4 adverse reaction was anemia; most common
    Grade 3-4 lab abnormality was decrease in hemoglobin

Clovis Oncology, Inc. (NASDAQ:CLVS) today announced that the U.S. Food
and Drug Administration (FDA) has approved Rubraca®
(rucaparib) tablets 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. FDA granted regular approval for Rubraca in this second,
broader and earlier-line indication on a priority review timeline based
on positive data from the phase 3 ARIEL3 clinical trial. Biomarker
testing is not required for patients to be prescribed Rubraca in this
maintenance treatment indication. Warnings and precautions include
Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML), and
embryo-fetal toxicity. Please see warnings and precautions and
additional Select Important Safety Information below.

This press release features multimedia. View the full release here:
https://www.businesswire.com/news/home/20180406005678/en/

Infographic: Understanding Ovarian Cancer (Graphic: Business Wire)

Infographic: Understanding Ovarian Cancer (Graphic: Business Wire)

In addition to granting Rubraca approval in this second indication, the
FDA converted the approval of the initial treatment indication from
accelerated to regular approval.

"Rubraca provided statistically-significant improvement in PFS versus
placebo to all patients, regardless of BRCA mutation status," said
Robert L. Coleman, MD, Professor & Executive Director, Cancer Network
Research, Ann Rife Cox Chair in Gynecology, Department of Gynecologic
Oncology and Reproductive Medicine at University of Texas MD Anderson
Cancer Center in Houston and one of the Principal Investigators in the
ARIEL3 clinical trial program. "Both the efficacy and safety results
from the ARIEL3 study reinforce the important role of Rubraca in the
treatment of recurrent ovarian cancer and expands the treatment options
for patients and physicians battling this disease."

"This FDA approval provides a meaningful advancement for the treatment
of women with recurrent ovarian cancer, offering them the potential to
reduce their risk of disease progression following platinum-based
chemotherapy," said Patrick J. Mahaffy, CEO and President of Clovis
Oncology. "We are grateful that the FDA expedited review of this
maintenance treatment indication, so that physicians can begin offering
it to appropriate patients beginning today."

On February 28, 2018, Rubraca was added to the National Comprehensive
Cancer Network (NCCN) Clinical Practice Guidelines in Oncology Ovarian
Cancer, as maintenance therapy for patients with platinum-sensitive
epithelial ovarian, fallopian tube and primary peritoneal cancer who are
in partial or complete response after completion of two or more lines of
platinum-based therapy. The NCCN designated Rubraca as a category 2A
treatment.

NCCN is a not-for-profit alliance that includes 27 of the world's
leading cancer institutions. The NCCN Guidelines document
evidence-based, consensus-driven management to ensure that all patients
receive preventive, diagnostic, treatment, and supportive services that
are most likely to lead to optimal outcomes.[1]

In December 2017, FDA accepted the Rubraca supplemental New Drug
Application (sNDA) application and granted priority review status.
Priority review designation is granted to proposed medicines that FDA
has determined have the potential, if approved, to offer a significant
improvement in the safety or effectiveness for the treatment, prevention
or diagnosis of a serious condition when compared to standard
applications. The Rubraca maintenance treatment approval is based on
positive results from the ARIEL3 study, which evaluated Rubraca in the
ovarian cancer maintenance-treatment setting among three populations: 1)
BRCA mutant (BRCAmut+) 2) HRD positive inclusive of BRCAmut+ and, 3) all
patients treated in ARIEL3. The study enrolled a total of 564 patients.

ARIEL3 successfully achieved both its primary and key secondary
endpoints, extending investigator assessed progression-free survival
(PFS) versus placebo in all patients treated, regardless of BRCA status.

                         
Parameter Investigator Assessment
      Rubraca   Placebo
All Patientsa
Patients, N       375   189
PFS events, n (%)       234 (62%)   167 (88%)
PFS, median in months       10.8   5.4
HR (95% CI)       0.36 (0.30, 0.45)
p-value       <0.0001
tBRCA Groupb
Patients, N       130   66
PFS events, n (%)       67 (52%)   56 (85%)
PFS, median in months       16.6   5.4
HR (95% CI)       0.23 (0.16, 0.34)
p-value       <0.0001
                    a.   All randomized patients
b.

tBRCA (tumor BRCA) includes all patients with a deleterious
germline or somatic BRCA mutation, as determined by the CTA.

 

Clovis announced topline results from the ARIEL3 clinical trial in June
2017. Additional data from the trial were presented at the 2017 European
Society for Medical Oncology (ESMO) Annual Conference in Madrid, Spain,
and subsequently published in The Lancet.

"The FDA approval of Rubraca in the maintenance treatment setting is an
important milestone for physicians and their patients with recurrent
ovarian cancer because it offers them greater flexibility to use this
novel PARP inhibitor, which has demonstrated significant clinical
efficacy and has been well received in practice," said Professor
Jonathan Ledermann, MD, Professor of Medical Oncology, Clinical
Director, UCL Cancer Institute, and European and the rest of world
Principal Investigator for the ARIEL3 study. "This will enable
physicians to offer Rubraca to more women with platinum-sensitive,
recurrent ovarian cancer."

"Tens of thousands of women will battle ovarian cancer every year," said
David Barley, Chief Executive Officer, National Ovarian Cancer
Coalition. "We need therapies that provide clinically meaningful
improvements in reducing the risk of disease progression, among women
with recurrent disease."

The safety evaluation of Rubraca 600 mg twice daily as monotherapy for
maintenance treatment is based on data from 561 patients with recurrent
ovarian cancer treated in the ARIEL3 trial. The safety and to

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