- New data analyses from the Phase 3 ARIEL3 and ARIEL4 trials
further characterize Rubraca’s efficacy and consistent safety
profile in patients in the advanced ovarian cancer maintenance
treatment and treatment settings
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that four
abstracts featuring data from clinical studies evaluating Rubraca
and/or lucitanib and one abstract on real world data of PARP
inhibitor usage, will be presented during the 2021 American Society
of Clinical Oncology (ASCO) Annual Meeting to be held virtually,
June 4-8, 2021.
“We remain committed to understanding how Rubraca and lucitanib
may benefit patients with cancer, and the data presented at ASCO
further enhance our understanding of their potential benefit in
different patient populations and solid tumor types,” said Patrick
J. Mahaffy, President and CEO of Clovis Oncology.
The following Clovis-sponsored full abstracts are available as
of May 19 at 5:00 pm ET on ASCO's Meeting Library. Clovis-sponsored
posters and supplemental information will be available as of June 3
at 5:00 pm ET at
https://clovisoncology.com/pipeline/scientific-presentations/.
Rubraca
Abstract #5517: Subgroup Analysis of Rucaparib Versus
Chemotherapy as Treatment for BRCA-mutated, Advanced, Relapsed
Ovarian Carcinoma: Effect of Platinum Sensitivity in the
Randomized, Phase 3 Study ARIEL4
- Lead Author: Amit M. Oza, MD, Princess Margaret Cancer Centre,
University Health Network, Toronto, Canada
- Poster Discussion Session: Gynecologic Cancer
- Date/Time: June 4 at 9:00 am ET
- Key Takeaways: Results from this exploratory subgroup analysis
of the Phase 3 ARIEL4 trial demonstrate that patients treated with
Rubraca had comparable or longer PFS vs. standard-of-care
platinum-chemotherapy across all platinum status subgroups. Safety
profiles for Rubraca and chemotherapy across the subgroups were
consistent with known safety profiles of these agents. These
results suggest that Rubraca is an effective treatment option for
heavily pretreated patients with BRCA-mutated, advanced, relapsed
ovarian cancer as compared to chemotherapy, regardless of their
sensitivity to platinum-based therapy.
Abstract #5537: Clinical and Molecular Characteristics of ARIEL3
Patients Who Derived Exceptional Benefit from Rucaparib Maintenance
Treatment for High-grade Ovarian Cancer (HGOC)
- Lead Author: Tanya Kwan, PhD, Clovis Oncology, Inc., Boulder,
Colorado, USA
- Poster Session: Gynecologic Cancer
- Date/Time: June 4 at 9:00 am ET
- Key Takeaways: In the Phase 3 ARIEL3 trial, exceptional benefit
(progression-free survival ≥2 years) was more common in, but not
exclusive to, patients with favorable clinical characteristics and
known mechanisms of PARP inhibitor sensitivity, including mutations
of BRCA1/2 and RAD51C/D. These results suggest that rucaparib can
deliver exceptional benefit to a diverse set of patients with
high-grade ovarian cancer. In all, 21% (79/375) of patients in the
rucaparib arm derived exceptional benefit versus only 2% (4/189) in
the placebo arm of the trial. Among rucaparib-treated patients,
incidence rates of the most common TEAEs were generally consistent
between the exceptional benefit subgroup and the overall ARIEL3
patient population.
Rubraca in Combination with Lucitanib
Abstract #3102: Phase 1b/2 SEASTAR Trial: Safety,
Pharmacokinetics, and Preliminary Efficacy of the Poly(ADP-ribose)
Polymerase (PARP) Inhibitor Rucaparib and Angiogenesis Inhibitor
Lucitanib in Patients with Advanced Solid Tumors
- Lead Author: Ecaterina E. Dumbrava, MD, The University of Texas
MD Anderson Cancer Center, Houston, Texas, USA
- Poster Session: Developmental Therapeutics – Molecularly
Targeted Agents and Tumor Biology
- Date/Time: June 4 at 9:00 am ET
- Key Takeaways: Initial findings suggest that rucaparib plus
lucitanib has an acceptable safety profile, and there was some
evidence of effect on tumor and disease stabilization among
patients with measurable disease, with a 23.5% disease control
rate. A maximum tolerated dose for the combination was not
established, and no drug-drug interactions were observed. These
data suggest the combination of a PARP inhibitor and an
angiogenesis inhibitor is feasible and may merit further
evaluation.
Lucitanib in Combination with Nivolumab
Abstract #5538: LIO-1: Lucitanib + Nivolumab in Patients with
Advanced Solid Tumors—Updated Phase 1b Results and Initial
Experience in Phase 2 Ovarian Cancer Cohort
- Lead Author: Erika Hamilton, MD, Sarah Cannon Research
Institute/Tennessee Oncology, Nashville, Tennessee, USA
- Poster Session: Gynecologic Cancer
- Date/Time: June 4 at 9:00 am ET
- Key Takeaways: Data from the Phase 1b LIO-1 trial identified
the Phase 2 starting dose of the combination and updated Phase 1b
efficacy data suggest that lucitanib plus nivolumab has promising
antitumor activity (47.1% disease control rate) with a manageable
safety profile in patients with advanced solid tumors with no
satisfactory treatment options. The Phase 2 study is currently
assessing four cohorts of patients with advanced gynecologic
malignancies. Interim results from one of these, non-clear cell
ovarian cancer (OC) are reported here. 70.8% of patients had
received at least 3 previous therapy lines, and 29.2% had primary
platinum resistant disease. In 22 evaluable patients, the disease
control rate was 31.8% including one confirmed PR. The safety
profile of the combination was consistent with that reported in the
Phase 1b portion of the study. In addition, the data support the
individualized lucitanib dose-titration strategy. While evidence of
clinical activity has been observed, Clovis does not believe that
the interim efficacy data support further development in non-clear
cell OC. Enrollment to the other cohorts continues.
HEOR
Abstract #e18702: Real-world Data Analysis of the Utilization of
Second-Line Maintenance Therapy for Patients with Advanced Ovarian
Cancer
- Lead Author: Robert Reid, MD, FACP, US Oncology, Virginia
Cancer Specialists, Fairfax, Virginia, USA
- Accessible as e-publication only
- Key Takeaways: Real world data from the iKnowMed electronic
database of the US Oncology Network (including >470 sites) found
that fewer than half of eligible ovarian cancer patients receive
second-line maintenance treatment, despite treatment guidelines
recommending its usage. In addition, the proportion of patients
receiving 2L PARPi maintenance increased from 17% in 2018 to 34% in
2019 but decreased to 22% in 2020.
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 is an unlicensed medical product outside of the U.S. and
Europe.
Rubraca Ovarian Cancer U.S. FDA Approved Indications
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.
Select Important Safety Information
Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) have
occurred 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.
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.
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%).
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.
You may also report side effects to Clovis Oncology, Inc. at
1-415-409-7220 (US toll) or 1-844-CLVS-ONC (1-844-258-7662; US
toll-free).
About Lucitanib
Lucitanib is an oral, potent inhibitor of the tyrosine kinase
activity of vascular endothelial growth factor receptors 1 through
3 (VEGFR1-3), platelet-derived growth factor receptors alpha and
beta (PDFGRα/β) and fibroblast growth factor receptors 1 through 3
(FGFR1-3). Emerging clinical data support the combination of
angiogenesis inhibitors and immunotherapy to increase effectiveness
in multiple cancer indications. Angiogenic factors, such as
vascular endothelial growth factor (VEGF), are frequently
up-regulated in tumors and create an immunosuppressive tumor
microenvironment. Use of antiangiogenic drugs may reverse this
immunosuppression and augment response to immunotherapy.
Lucitanib is an unlicensed medical product.
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. 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 and lucitanib
for certain patient populations or indications, and our plans to
develop Rubraca and lucitanib 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210519005980/en/
Clovis Investor Contacts: Anna Sussman,
303.625.5022 asussman@clovisoncology.com
Breanna Burkart, 303.625.5023 bburkart@clovisoncology.com
Clovis Media Contacts: Lisa Guiterman, 301.217.9353
clovismedia@clovisoncology.com
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