- ATHENA study evaluating Rubraca monotherapy versus placebo
(ATHENA-MONO) successfully achieved the primary endpoint of
improved PFS in both populations in the primary efficacy analyses:
HRD-positive and all patients randomized (ITT)
- Median PFS of 20.2 months for Rubraca vs 9.2 months for placebo
in the ITT population
- The exploratory PFS endpoints were also achieved in both
HRD-negative and BRCA mutant subgroups of patients
- Safety of Rubraca observed in ATHENA-MONO was consistent with
both the current US and European labels
- ATHENA-MONO results will serve as the basis of a supplemental
NDA for US label expansion to be submitted during Q2 2022; European
submission to follow during Q3 2022
- These data, including additional analyses, have been submitted
for presentation at the American Society of Clinical Oncology
Annual Meeting in June 2022
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced positive
top-line data from the monotherapy arm of the ATHENA (GOG
3020/ENGOT-ov45) trial (ATHENA-MONO) demonstrating that Rubraca as
maintenance treatment successfully achieved the primary endpoint of
significantly improved investigator-assessed progression-free
survival (PFS) compared with placebo. Benefit was observed in both
primary efficacy analyses of newly-diagnosed patients with advanced
ovarian cancer following successful treatment with platinum-based
chemotherapy: those who had homologous recombination deficiency
(HRD-positive)1, including deleterious BRCA mutations, as well as
all patients randomized in the trial (overall intent-to-treat
population (ITT)). Benefit in PFS was also seen in the exploratory
subgroups of patients with HRD-negative2 and BRCA mutant (BRCAm)
tumors. The safety of Rubraca observed in the ATHENA-MONO study was
consistent with both the US and European labels.
Based on these results, the Company plans to submit a
supplemental New Drug Application (sNDA) to the US FDA during the
second quarter of 2022 followed by a Type II Variation to the EMA
during the third quarter of 2022 for a first-line maintenance
treatment indication for women with advanced ovarian cancer
regardless of biomarker status who have responded to first-line
platinum-based chemotherapy.
“The results from the ATHENA-MONO study of Rubraca in first-line
maintenance treatment ovarian cancer exceeded our expectations in
terms of significant improvement in PFS versus placebo in each of
the primary efficacy populations, including the all-comers or
intent-to-treat population,” said Patrick J. Mahaffy, President and
CEO of Clovis Oncology. “We believe that the positive results from
ATHENA-MONO demonstrate that Rubraca will provide an important new
treatment option for women with advanced ovarian cancer in the
first-line maintenance setting, and we look forward to submitting
these data to the regulatory authorities in the US and Europe
during Q2 and Q3 2022, respectively. Most importantly, I would like
to thank the patients, physicians, and our colleagues whose
commitment to this trial made these results possible, which now
offer the potential to make a difference in the lives of many women
with advanced ovarian cancer. We would also like to thank GOG and
ENGOT for their partnership in conducting this large and very
important trial.”
“While PARP inhibitors have shown efficacy as first-line
maintenance treatment for patients with advanced ovarian cancer,
questions still remain about the patient population that may
benefit from their use. The results of ATHENA-MONO address many of
these unanswered questions and expands the opportunity for
rucaparib in all patients regardless of 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.
“I believe the significant improvement in PFS demonstrated in
the ATHENA-MONO trial underscores the importance of first-line
maintenance therapy and the benefit that rucaparib can provide to
women with advanced ovarian cancer irrespective of 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. “Ovarian cancer remains a leading cause of
cancer-related death among women, which highlights the continued
need for new treatment options and strategies for women with
newly-diagnosed disease. The ATHENA-MONO study demonstrates the
role of rucaparib monotherapy in the first-line maintenance
treatment setting for advanced ovarian cancer.”
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 top-line
results reported today are from the ATHENA-MONO part (rucaparib vs
placebo) with results from the ATHENA-COMBO part
(rucaparib+nivolumab vs rucaparib) now expected in Q1 2023 based on
a slower than expected event count.
ATHENA-MONO enrolled 538 women with high-grade ovarian,
fallopian tube, or primary peritoneal cancer. The primary efficacy
analysis evaluated two prospectively defined molecular sub-groups
in a step-down manner: 1) HRD-positive (inclusive of BRCAm tumors),
and 2) all patients randomized (ITT) in ATHENA-MONO.
Following is a summary of the primary efficacy analyses by
investigator review, the primary analysis of ATHENA-MONO.
Significant Improvement in PFS in the HRD-positive Patient
Population
By investigator review, the rucaparib arm (n=185) successfully
achieved statistical significance over the placebo arm (n=49) for
the primary endpoint of PFS with a hazard ratio of 0.47 (95% CI:
0.31-0.72). The median PFS for the HRD-positive patient population
treated with rucaparib was 28.7 months vs 11.3 months among those
who received placebo (p=0.0004).
Significant Improvement in PFS in All Patients Studied (ITT
or all comers)
Rucaparib also showed statistical significance in all 538
patients randomized in the ATHENA-MONO comparison. By investigator
review, the rucaparib arm (n=427) successfully achieved statistical
significance over the placebo arm (n=111) for the primary endpoint
of PFS with a hazard ratio of 0.52 (95% CI: 0.40-0.68). The median
PFS for all patients enrolled in ATHENA-MONO and treated with
rucaparib was 20.2 months vs 9.2 months among those who received
placebo (p<0.0001).
Treatment Benefit in PFS Endpoint for Exploratory
HRD-negative Subgroup
By investigator review, the PFS endpoint in the exploratory
subgroup of HRD-negative demonstrated a hazard ratio of 0.65 (95%
CI: 0.45-0.95). The median PFS for these patients treated with
rucaparib (n=189) was 12.1 months vs. 9.1 months for those who
received placebo (n=49) (p=0.0284).
Treatment Benefit in PFS Endpoint for Exploratory BRCAm
Subgroup
By investigator review, the PFS endpoint in the exploratory
subgroup of BRCAm demonstrated a hazard ratio of 0.40 (95% CI:
0.21-0.75). The median PFS for these patients treated with
rucaparib (n=91) was Not Reached vs 14.7 months for those who
received placebo (n=24) (p=0.0041).
Results were consistent for the germline BRCA (n=68) and somatic
BRCA (n=33) and unknown (n=14) populations.
Summary of ATHENA-MONO Safety
The safety of Rubraca observed in ATHENA-MONO was consistent
with both the current US and European labels. The most common (≥5%)
treatment-emergent grade 3/4 adverse events (TEAEs) among all
patients treated with rucaparib in the monotherapy portion of the
ATHENA study were anemia/decreased hemoglobin (28.7%), neutropenia
(14.6%), ALT/AST increase (10.6%), and thrombocytopenia (7.1%). The
discontinuation rate for TEAEs was 11.8% for rucaparib-treated
patients and 5.5% for the placebo arm. The rate of
treatment-emergent myelodysplastic syndrome (MDS)/acute myeloid
leukemia (AML) in the rucaparib arm was 0.2%, and no patients on
the placebo arm experienced treatment-emergent MDS/AML.
Clovis Oncology plans to provide an expanded description of the
ATHENA-MONO results in a scientific session at a medical meeting
later this year; these data have been submitted for presentation at
the American Society of Clinical Oncology Annual Meeting in June
2022.
Rubraca is not currently approved in the first-line ovarian
cancer maintenance setting. Clovis intends to provide these data to
US and European regulatory authorities and is on track to submit
filings during the second and third quarters of 2022, respectively,
in those geographies.
Conference Call Details
Clovis will hold a conference call to discuss the ATHENA-MONO
results this morning, March 31, at 8:30am ET. The conference call
will be simultaneously webcast on the Company’s web site at
www.clovisoncology.com, and archived for future review. Dial-in
numbers for the conference call are as follows: US participants
888.440.4615, International participants 646.960.0682, conference
ID: 2259685.
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, BRCAwt)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 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 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.
1 HRD-positive may also be referred to as HR-deficient, HRD,
HRD+, HRd, or biomarker positive
2 HRD-negative may also be referred to as HR-proficient, HRD-,
HRp, or biomarker negative
i Monk 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.
ii Hanker 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.
iii Pal 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.
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.
v Konstantinopoulos 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
vi Quesada 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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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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