- First presentation of data from the Phase 3 ATHENA trial
evaluating Rubraca monotherapy versus placebo (ATHENA-MONO) to be
presented as a late-breaking, oral abstract at the 2022 ASCO Annual
Meeting and published simultaneously in the Journal of Clinical
Oncology (JCO)
- The ATHENA-MONO trial met its primary endpoint, showing Rubraca
monotherapy versus placebo improved progression-free survival (PFS)
by investigator assessment in both populations in the primary
efficacy analyses: HRD-positive and all patients randomized
(ITT)
- Significant improvement in PFS by BICR assessment, a secondary
endpoint of the study, was also observed in both the HRD-positive
and ITT populations
- Benefit in PFS was also seen in the exploratory subgroup of
patients with HRD-negative tumors, those within the HRD-positive
population with either BRCA mutant or BRCA wild type/LOH high
tumors and those with BRCA wild type disease whose LOH status could
not be determined; results were similar for investigator- and
BICR-assessment
- Safety of Rubraca observed in ATHENA-MONO was consistent with
both the current US and European labels
Clovis Oncology, Inc. (NASDAQ: CLVS) announced today the first
presentation of data from the monotherapy arm of the randomized,
Phase 3 ATHENA (GOG-3020/ENGOT-ov45) trial (ATHENA-MONO) as a
late-breaking oral abstract (LBA5500) to be presented on Monday,
June 6, at the 2022 American Society of Clinical Oncology (ASCO)
Annual Meeting in Chicago. The data demonstrate that Rubraca as
first-line maintenance treatment significantly improved
investigator-assessed progression-free survival (PFS) compared with
placebo in women with advanced ovarian cancer irrespective of
biomarker status. The results were simultaneously published in the
Journal of Clinical Oncology and are available starting at 9:00
a.m. EDT on June 6.
“The results from the monotherapy portion of the Phase 3 ATHENA
trial (ATHENA-MONO), demonstrate that eligible patients with
advanced ovarian cancer who previously responded to platinum based
chemotherapy can benefit from first-line maintenance treatment with
rucaparib, regardless of their biomarker status,” said Bradley J.
Monk, MD, FACOG, FACS, at GOG Foundation, HonorHealth Research
Institute, University of Arizona College of Medicine, Creighton
University School of Medicine, Phoenix, AZ and global primary
investigator of the ATHENA trial. “Currently, the optimal
first-line maintenance strategy for treating newly diagnosed
advanced ovarian cancer remains unclear, demonstrating the need for
treatment advances in this setting.”
“The data from the ATHENA-MONO portion of the trial validate the
use of rucaparib for the first-line maintenance treatment of
advanced ovarian cancer regardless of BRCA mutation and HRD
status,” said Rebecca S. Kristeleit, MD, PhD, of Guy’s and St
Thomas’ NHS Foundation Trust in London and lead ENGOT/NCRI National
Cancer Research Institute (https://www.ncri.org.uk/) investigator
of the ATHENA trial. “Rucaparib significantly improved
progression-free survival in all populations randomized, with
median PFS in the rucaparib arm more than double that observed in
the placebo arm of the trial.”
Dr. Monk will present “ATHENA-MONO (GOG-3020/ENGOT-ov45): A
randomized, double-blind, phase 3 trial evaluating rucaparib
monotherapy versus placebo as maintenance treatment following
response to first-line platinum-based chemotherapy in ovarian
cancer” from 9:00 – 9:12 a.m. EDT during an Oral Abstract Session
focused on gynecologic cancer that will be held from 9:00 a.m. –
noon EDT on Monday, June 6. Building on the topline primary results
previously announced, the presentation will feature an expanded
description of the ATHENA-MONO study results including Kaplan-Meier
curves and key secondary endpoints including PFS results by blinded
independent centralized review (BICR) and other analyses. The
presentation can also be viewed at
https://www.clovisoncology.com/pipeline/scientific-presentations/
starting at 8:00 a.m. EDT on June 6.
ATHENA is a double-blind, placebo-controlled, Phase 3 trial of
rucaparib in first-line ovarian cancer maintenance treatment. It
has two parts which are statistically independent. The results
presented at ASCO are from the ATHENA-MONO part (rucaparib versus
placebo), with results from the ATHENA-COMBO part (rucaparib plus
nivolumab versus rucaparib) expected in Q1 2023.
ATHENA-MONO enrolled 538 women with high-grade ovarian,
fallopian tube, or primary peritoneal cancer. The primary efficacy
analysis evaluated two prospectively defined molecular subgroups in
a step-down manner: 1) HRD-positive (inclusive of BRCAm tumors and
BRCAwt/LOH high tumors), and 2) all patients randomized (overall
intent-to-treat population [ITT]) in ATHENA-MONO.
Significant Improvement in PFS in the HRD-Positive Patient
Population
For the primary endpoint of PFS by investigator review in the
HRD-positive patient population, the rucaparib arm (n=185) showed
statistically significant improvement over the placebo arm (n=49)
with a hazard ratio of 0.47 (95% CI: 0.31-0.72) representing a 53
percent reduction in the risk of disease progression. The median
PFS for the HRD-positive patient population treated with rucaparib
was 28.7 months compared to 11.3 months among those who received
placebo (p=0.0004).
For the secondary endpoint of PFS by blinded independent central
review (BICR) in the HRD-positive patient population, the rucaparib
arm showed statistically significant improvement over the placebo
arm with a hazard ratio of 0.44 (95% CI: 0.28-0.70) representing a
56 percent reduction in the risk of disease progression. The median
PFS for the HRD-positive population treated with rucaparib was not
reached compared to 9.9 months among those who received placebo
(p=0.0004).
Significant Improvement in PFS in All Patients Studied (ITT
or all patients randomized)
For the primary endpoint of PFS by investigator review in the
ITT or all patients randomized population, the rucaparib arm
(n=427) showed statistically significant improvement over the
placebo arm (n=111) with a hazard ratio of 0.52 (95% CI: 0.40-0.68)
representing a 48 percent reduction in the risk of disease
progression. The median PFS for all patients randomized in
ATHENA-MONO and treated with rucaparib was 20.2 months compared to
9.2 months among those who received placebo (p<0.0001).
For the secondary endpoint of PFS by BICR in the ITT or all
patients randomized population, the rucaparib arm showed
statistically significant improvement over the placebo arm with a
hazard ratio of 0.47 (95% CI: 0.36-0.63; p<0.0001) representing
a 53 percent reduction in the risk of disease progression. The
median PFS for all patients randomized in ATHENA-MONO and treated
with rucaparib was 25.9 months compared to 9.1 months among those
who received placebo (p<0.0001).
Treatment Benefit in Exploratory Subgroups
In the exploratory subgroups studied, rucaparib demonstrated
treatment benefit versus placebo regardless of BRCA mutation and
HRD status.
HRD-positive BRCA-mutant Subgroup:
For PFS by investigator review, the rucaparib arm (n=91)
demonstrated benefit over the placebo arm (n=24) with a hazard
ratio of 0.40 (95% CI: 0.21-0.75) representing a 60 percent
reduction in the risk of disease progression. The median PFS was
not reached for those treated with rucaparib compared to 14.7
months for those who received placebo.
For PFS by BICR, the rucaparib arm demonstrated benefit over the
placebo arm with a hazard ratio of 0.48 (95% CI: 0.23-1.00)
representing a 52 percent reduction in the risk of disease
progression. The median PFS for the HRD-positive BRCA-mutant
subgroup in ATHENA-MONO was not reached for those treated with
rucaparib or those who received placebo.
HRD-positive BRCA Wild-type/LOH-high Subgroup:
For PFS by investigator review, the rucaparib arm (n=94)
demonstrated benefit over the placebo arm (n=25) with a hazard
ratio of 0.58 (95% CI: 0.33-1.01) representing a 42 percent
reduction in the risk of disease progression. The median PFS was
20.3 months for those treated with rucaparib compared to 9.2 months
for those who received placebo.
For PFS by BICR, the rucaparib arm demonstrated benefit over the
placebo arm with a hazard ratio of 0.46 (95% CI: 0.26-0.81)
representing a 54 percent reduction in the risk of disease
progression. The median PFS was 27.8 months for those treated with
rucaparib compared to 9.1 months for those who received
placebo.
HRD-negative BRCA Wild-type/LOH-low Subgroup:
For PFS by investigator review, the rucaparib arm (n=189)
demonstrated benefit over the placebo arm (n=49) with a hazard
ratio of 0.65 (95% CI: 0.45-0.95) representing a 35 percent
reduction in the risk of disease progression. The median PFS was
12.1 months for those treated with rucaparib compared to 9.1 months
for those who received placebo.
For PFS by BICR, the rucaparib arm demonstrated benefit over the
placebo arm with a hazard ratio of 0.60 (95% CI: 0.40-0.89)
representing a 40 percent reduction in the risk of disease
progression. The median PFS was 12.0 months for those treated with
rucaparib compared to 6.4 months for those who received
placebo.
BRCA Wild-type LOH Status Unknown Subgroup:
For PFS by investigator review, the rucaparib arm (n=53)
demonstrated benefit over the placebo arm (n=13) with a hazard
ratio of 0.39 (95% CI: 0.20-0.78) representing a 61 percent
reduction in the risk of disease progression. The median PFS was
17.5 months for those treated with rucaparib compared to 8.9 months
for those who received placebo.
For PFS by BICR, the rucaparib arm demonstrated benefit over the
placebo arm with a hazard ratio of 0.33 (95% CI: 0.16-0.68)
representing a 67 percent reduction in the risk of disease
progression. The median PFS was 17.4 months for those treated with
rucaparib compared to 6.5 months for those who received
placebo.
Summary of ORR and DoR
Among the HRD patient population, 17 patients in the rucaparib
arm had measurable disease at baseline, 10 patients had confirmed
ORR (overall response rate) per RECIST criteria (ORR: 10/17
[58.8%]; 95% CI: 32.9-81.6) compared to one in the placebo arm with
measurable disease (ORR: 1/5 [20.0%]; 95% CI: 0.5-71.6). Ten
patients treated with rucaparib experienced a partial response,
compared to one patient in the placebo arm.
In the ITT population, 41 patients in the rucaparib arm had
measurable disease at baseline, 20 patients had confirmed ORR per
RECIST criteria (ORR: 20/41 [48.8%]; 95% CI: 32.9-64.9) compared to
1 in the placebo arm with measurable disease (ORR: 1/11 [9.1%]; 95%
CI: 0.2-41.3). Nineteen patients in the rucaparib arm had a partial
response versus one in the placebo arm.
Additionally, the median duration of response for HRD-positive
patients in the rucaparib treatment arm was 16.7 months (95% CI:
5.7-not reached) and 22.1 months (95% CI: 8.4-not reached) in the
ITT population, compared to 5.5 months (95% CI not applicable, with
only one responder) in the placebo arm.
The secondary endpoint overall survival (OS) remains immature.
At visit cutoff, 24.7% of events had occurred. At the current
maturity, the hazard ratios of the OS in ATHENA-MONO in the
HRD-positive and ITT populations are 0.97 (95% CI: 0.43-2.19) and
0.96 (95% CI: 0.63-1.47), respectively.
Safety Profile of Rucaparib
The safety profile observed in ATHENA-MONO was consistent with
both the current US and European labels for rucaparib. The most
common (≥5%) treatment-emergent grade ≥3 adverse events (TEAEs)
among all patients treated with rucaparib (n=425) in the
ATHENA-MONO comparison were anemia or decreased hemoglobin (28.7%),
neutropenia or neutrophil count decreased (14.6%), increased
ALT/AST (10.6%), and thrombocytopenia or platelet count decreased
(7.1%). AST/ALT elevations were not accompanied by significant
changes in bilirubin and there were no reports of drug induced
liver toxicity as defined by Hy’s Law. The discontinuation rate due
to TEAEs was 11.8% for rucaparib-treated patients and 5.5% for the
placebo arm; there were two deaths (0.5%) due to TEAEs for
rucaparib-treated patients and zero for the placebo arm. Median
treatment duration for the rucaparib arm was 14.7 months versus 9.9
months for the placebo arm. Myelodysplastic syndrome (MDS)/acute
myeloid leukemia (AML) was reported by two patients in the
rucaparib group (one MDS during treatment; one AML during long-term
follow-up) and no patients in the placebo group.
More than 70% of patients continued to receive ≥500 mg BID
(>80% starting dose) Rubraca through month 12. Changes from
baseline in FACT-O TOI scores were similar between rucaparib and
placebo in the ITT population.
“These results further confirm that patients with advanced
ovarian cancer regardless of biomarker status can benefit from
first-line maintenance treatment with Rubraca,” said Patrick J.
Mahaffy, President and CEO of Clovis Oncology. “We would like to
thank all patients, caregivers and physicians who participated in
this trial, the results of which we believe demonstrate the benefit
Rubraca can offer to eligible women with advanced ovarian cancer in
the first-line maintenance treatment setting.”
As previously disclosed, Clovis is currently evaluating the
timing of the planned sNDA and Type II variation submissions.
Rubraca is not currently approved in the first-line ovarian
cancer maintenance setting.
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 US and
Europe.
Rubraca Ovarian Cancer US 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).
Rubraca (rucaparib) European Union (EU) including Northern
Ireland, and Great Britain (GB) authorized use and Important Safety
Information
Rubraca is indicated as monotherapy for the maintenance
treatment of adult patients 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 indicated as monotherapy 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 ≥2
prior lines of platinum-based chemotherapy, and who are unable to
tolerate further platinum-based chemotherapy.
Efficacy of Rubraca as treatment for relapsed or progressive
epithelial ovarian cancer (EOC), fallopian tube cancer (FTC), or
primary peritoneal cancer (PPC) has not been investigated in
patients who have received prior treatment with a PARP inhibitor.
Therefore, use in this patient population is not recommended.
Summary warnings and precautions:
Hematological toxicity
During treatment with Rubraca, events of myelosuppression
(anemia, neutropenia, thrombocytopenia) may be observed and are
typically first observed after 8–10 weeks of treatment with
Rubraca. These reactions are manageable with routine medical
treatment and/or dose adjustment for more severe cases. Complete
blood count testing prior to starting treatment with Rubraca, and
monthly thereafter, is advised. Patients should not start Rubraca
treatment until they have recovered from hematological toxicities
caused by previous chemotherapy (CTCAE grade ≥1).
Supportive care and institutional guidelines should be
implemented for the management of low blood counts for the
treatment of anemia and neutropenia. Rubraca should be interrupted
or dose reduced according to Table 1 (see Posology and Method of
Administration [4.2] of the Summary of Product Characteristics
[SPC]) and blood counts monitored weekly until recovery. If the
levels have not recovered to CTCAE grade 1 or better after 4 weeks,
the patient should be referred to a hematologist for further
investigations.
MDS/AML
MDS/AML, including cases with fatal outcome, have been reported
in patients who received Rubraca. The duration of therapy with
Rubraca in patients who developed MDS/AML varied from less than 1
month to approximately 28 months.
If MDS/AML is suspected, the patient should be referred to a
hematologist for further investigations, including bone marrow
analysis and blood sampling for cytogenetics. If, following
investigation for prolonged hematological toxicity, MDS/AML is
confirmed, Rubraca should be discontinued.
Photosensitivity
Photosensitivity has been observed in patients treated with
Rubraca. Patients should avoid spending time in direct sunlight
because they may burn more easily during Rubraca treatment; when
outdoors, patients should wear a hat and protective clothing, and
use sunscreen and lip balm with sun protection factor of 50 or
greater.
Gastrointestinal toxicities
Gastrointestinal toxicities (nausea and vomiting) are frequently
reported with Rubraca and are generally low grade (CTCAE grade 1 or
2) and may be managed with dose reduction (refer to Posology and
Method of Administration [4.2], Table 1 of the SPC) or
interruption. Antiemetics, such as 5-HT3 antagonists,
dexamethasone, aprepitant and fosaprepitant, can be used as
treatment for nausea/vomiting and may also be considered for
prophylactic (i.e. preventative) use prior to starting Rubraca. It
is important to proactively manage these events to avoid prolonged
or more severe events of nausea/vomiting which have the potential
to lead to complications such as dehydration or
hospitalization.
Embryofetal toxicity
Rubraca can cause fetal harm when administered to a pregnant
woman based on its mechanism of action and findings from animal
studies. In an animal reproduction study, administration of Rubraca
to pregnant rats during the period of organogenesis resulted in
embryo-fetal toxicity at exposures below those in patients
receiving the recommended human dose of 600 mg twice daily (see
Preclinical Safety Data [5.3] of the SPC).
Pregnancy/contraception
Pregnant women should be informed of the potential risk to a
fetus. Women of reproductive potential should be advised to use
effective contraception during treatment and for 6 months following
the last dose of Rubraca (see section 4.6 of the SPC). A pregnancy
test before initiating treatment is recommended in women of
reproductive potential.
Click here to access the current EU SmPC (including for Northern
Ireland). Click here to access the current GB SmPC.
Healthcare professionals should report any suspected adverse
reactions via their national reporting systems.
About the ATHENA Clinical Trial
ATHENA (GOG 3020/ENGOT-ov45) (NCT03522246) is an international,
randomized, double-blind, phase III trial consisting of two
separate and fully independently powered study comparisons
evaluating Rubraca monotherapy (ATHENA-MONO) and Rubraca in
combination with nivolumab (ATHENA-COMBO) as maintenance treatment
for patients with newly diagnosed advanced epithelial ovarian,
fallopian tube, or primary peritoneal cancer. ATHENA enrolled
approximately 1000 patients across 24 countries, all women with
newly diagnosed ovarian cancer who responded to their first-line
chemotherapy. The trial completed accrual in 2020 and was conducted
in association with the Gynecologic Oncology Group (GOG) in the US
and the European Network of Gynaecological Oncological Trial groups
(ENGOT) in Europe. GOG and ENGOT are the two largest cooperative
groups in the US and Europe dedicated to the treatment of
gynecological cancers.
ATHENA-MONO is evaluating the benefit of Rubraca monotherapy
versus placebo in 538 women in this patient population. The primary
efficacy analysis evaluated two prospectively defined molecular
sub-groups in a step-down manner: 1) HRD-positive (inclusive of
BRCA mutant) tumors, and 2) the intent-to-treat population, or all
patients treated in ATHENA-MONO.
The ATHENA-COMBO portion of the trial, anticipated to readout in
Q1 2023, is evaluating the magnitude of benefit of adding Opdivo
(nivolumab) to Rubraca monotherapy in the ovarian cancer first-line
maintenance treatment setting. ATHENA-COMBO is anticipated to be
the first Phase 3 dataset to readout evaluating the combination of
a PARP inhibitor and an immune checkpoint inhibitor as maintenance
treatment following completion and response to front-line
chemotherapy.
About Ovarian Cancer
Ovarian cancer is the eighth leading cause of cancer-related
death among women worldwide. In 2020, GLOBOCAN estimated 314,000
women received a new diagnosis of ovarian cancer and approximately
207,200 women died from ovarian cancer. According to the American
Cancer Society, an estimated more than 19,000 women will be
diagnosed with ovarian cancer in the United States and there will
be an estimated nearly 13,000 deaths from ovarian cancer in 2022.
According to GLOBOCAN, an estimated 66,000 women in Europe are
diagnosed each year with ovarian cancer, and ovarian cancer is
among those cancers with the highest rate of deaths. According to
the NIH National Cancer Institute, more than 75% of women are
diagnosed with ovarian cancer at an advanced stage.
Despite recent advances in the therapeutic landscape of newly
diagnosed ovarian cancer, advanced ovarian cancer is still
considered incurable for the majority of patients, and the optimal
treatment strategy has yet to be determined.i Although most respond
initially to this treatment, 80% of patients with advanced ovarian
cancer will have a recurrence and require subsequent
therapies.ii
About Biomarkers in Ovarian Cancer
In the high-grade epithelial ovarian cancer setting, a patient’s
tumor can be classified based on the genetic biomarker status:
those with homologous recombination deficiencies, or HRD-positive,
include those with a mutation of the BRCA gene (BRCAm), inclusive
of germline and somatic mutations of BRCA, which represent
approximately 25 percent of patientsiii,iv; and those with a range
of genetic abnormalities other than BRCAm, which result in other
homologous recombination deficiencies that represent an additional
estimated 25 percent of patients (HRD-positive, BRCA wild-type)v;
in addition, those whose test results show no deficiencies in
homologous recombination repair (HRD-negative) represent the
remaining approximate 50 percent of patients.vi
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on
acquiring, developing, and commercializing innovative anti-cancer
agents in the US, 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 US 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, statements regarding our
expectations concerning future regulatory activities, expectations
for submission of regulatory filings, our plans to present final or
interim data on ongoing clinical trials, our plans to submit
additional data to, or meet with, the FDA with respect to the
status of or plans for ongoing or planned trials, the timing and
pace of commencement of enrollment in and conduct of our clinical
trials, the potential results of such clinical trials and the
potential for marketing authorizations for new indications, our
expectations regarding the suitability of Rubraca, and our plans to
develop Rubraca in additional indications and tumor types. 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.
iMonk BJ et al. ATHENA (GOG-3020/ENGOT-ov45): a randomized,
phase III trial to evaluate rucaparib as monotherapy (ATHENA–MONO)
and rucaparib in combination with nivolumab (ATHENA–COMBO) as
maintenance treatment following frontline platinum-based
chemotherapy in ovarian cancer. Int J Gynecol Cancer. 2021;0:1–6.
iiHanker LC et al. The impact of second to sixth line therapy on
survival of relapsed ovarian cancer after primary
taxane/platinum-based therapy. Ann Oncol. 2012;23(10):2605-2612.
doi:10.1093/annonc/mds203. iiiPal T, Permuth-Wey J, Betts JA, et
al. BRCA1 and BRCA2 mutations account for a large proportion of
ovarian carcinoma cases. Cancer. 2005;104(12):2807-2816.
ivPennington 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. vKonstantinopoulos
PA, Ceccaldi R, Shapiro GI, D’Andrea AD. Homologous recombination
deficiency: exploiting the fundamental vulnerability of ovarian
cancer. Cancer Discov. 2015;5(11):1137-1154 viQuesada S, Fabbro M,
Jerome Solassol. Toward more comprehensive homologous recombination
deficiency assays in ovarian cancer part 2: medical perspectives,
Cancers. 2022; 14, 1098.
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version on businesswire.com: https://www.businesswire.com/news/home/20220606005203/en/
Clovis Investor Contacts: Anna Sussman, 303.625.5022
asussman@clovisoncology.com or Breanna Burkart, 303.625.5023
bburkart@clovisoncology.com
Clovis Media Contacts: US Lisa Guiterman,
301.347.7964 clovismedia@clovisoncology.com
Europe Jake Davis, +44 (0) 20.3946.3538
Jake.Davis@publicisresolute.com
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