- Updated data from the Phase 2 TRITON2 trial of Rubraca in
patients with advanced metastatic castration-resistant prostate
cancer (mCRPC)
- Exploratory ARIEL3 analysis for Rubraca maintenance
treatment regimen in ovarian cancer based on response to prior
platinum-based chemotherapy
- Integrated safety analysis of Rubraca in ovarian cancer
treatment and maintenance treatment settings
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that three
posters highlighting studies from the Rubraca® (rucaparib) clinical
development program will be presented at the ESMO (European Society
for Medical Oncology) Congress 2019, September 27 – October 1,
2019, in Barcelona, Spain.
The accepted abstracts summarize clinical trials in which
Rubraca is being evaluated as a single agent in advanced ovarian
and prostate cancers. These posters include updated results from
the ongoing Phase 2 TRITON2 clinical trial of Rubraca in advanced
mCRPC and additional analyses of data from the Study 10, ARIEL2 and
ARIEL3 clinical trials in advanced ovarian cancer, which evaluated
safety and efficacy in the treatment and maintenance settings.
The data from the TRITON2 trial will be presented in a poster by
Professor Ray McDermott, Consultant Medical Oncologist, Tallaght
University Hospital and Cancer Trials Ireland, and have been
selected for inclusion in a poster discussion session on Sunday,
September 29. TRITON2 is an ongoing international, multicenter,
open-label, Phase 2 trial of Rubraca in men with advanced prostate
cancer with a deleterious BRCA gene mutation (germline or somatic)
or deleterious mutation in other homologous recombination repair
genes in the metastatic castration-resistant setting.
“We look forward to presenting an updated look at the TRITON2
prostate cancer data at ESMO, with a primary focus on patient
populations with a deleterious BRCA gene mutation, as well as
mutations of other homologous recombination repair genes,” said
Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We
continue to prepare to file a supplemental NDA for Rubraca in
BRCA-mutant advanced prostate cancer by the end of the year.”
In October 2018, Clovis Oncology announced that the U.S. Food
and Drug Administration (FDA) granted Breakthrough Therapy
designation for Rubraca for the treatment of adult patients with
BRCA1/2-mutated mCRPC who have received at least one prior androgen
receptor-directed therapy and taxane-based chemotherapy.
Additional analyses of data from the Study 10, ARIEL2 and ARIEL3
clinical trials, which supported the European Union (EU) and FDA
approvals of Rubraca for women with advanced ovarian cancer in the
treatment and maintenance settings, will also be presented.
The three Rubraca abstracts from Clovis Oncology that have been
accepted for either poster discussion or poster presentation at the
ESMO Congress 2019 include:
Title: Preliminary results from the TRITON2 study of
rucaparib in patients (pts) with DNA damage repair (DDR)-deficient
metastatic castration-resistant prostate cancer (mCRPC): updated
analyses (abstract 846PD) Presenter: Professor Ray
McDermott, Consultant Medical Oncologist, Tallaght University
Hospital and Cancer Trials Ireland Session: Poster
discussion session, genitourinary tumors, prostate
Date/Time: Sunday 29 September, 08:30–09:45 CEST
Location: Malaga Auditorium (Hall 5)
As the subject of a poster discussion session, this poster
will be on display for the duration of the congress in Hall 3
beginning at 07:30 CEST on Saturday, September 28 2019.
Title: Effect of response to last platinum-based
chemotherapy in patients (pts) with platinum-sensitive, recurrent
ovarian carcinoma in the Phase 3 study ARIEL3 of rucaparib
maintenance treatment (abstract 1001P) Presenter: Professor
Jonathan A. Ledermann, UCL Cancer Institute, University College
London and UCL Hospitals, London, UK Session: Poster display
session 2 Date/Time: Sunday 29 September, 12:00–13:00 CEST
Location: Poster Area (Hall 4)
Title: Integrated safety analysis of the poly
(ADP-ribose) polymerase (PARP) inhibitor rucaparib in patients
(pts) with ovarian cancer in the treatment and maintenance settings
(abstract 1002P) Presenter: Dr. Rebecca S. Kristeleit,
University College London and UCL Hospitals, London, UK
Session: Poster display session 2 Date/Time: Sunday
29 September, 12:00–13:00 CEST Location: Poster Area (Hall
4)
Specific program times and locations are subject to change by
ESMO. Clovis Oncology’s Rubraca poster presentations will be
available online at
http://clovisoncology.com/pipeline/scientific-presentations once
they are presented at the meeting.
About Rubraca® (rucaparib)
Rubraca 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 U.S. FDA Approved Indications
Rubraca is indicated as monotherapy for the maintenance
treatment of adult patients with recurrent epithelial ovarian,
fallopian tube, or primary peritoneal cancer who are in complete or
partial response to platinum-based chemotherapy.
Rubraca is indicated as monotherapy for the treatment of adult
patients with deleterious BRCA mutations (germline and/or somatic)
associated epithelial ovarian, fallopian tube, or primary
peritoneal cancer who have been treated with two or more
chemotherapies and selected for therapy based on an FDA-approved
companion diagnostic for Rubraca.
Select Important Safety Information
Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML)
occur uncommonly in patients treated with Rubraca, and are
potentially fatal adverse reactions. In approximately 1100 treated
patients, MDS/AML occurred in 12 patients (1.1%), including those
in long-term follow-up. Of these, five occurred during treatment or
during the 28-day safety follow-up (0.5%). The duration of Rubraca
treatment prior to the diagnosis of MDS/AML ranged from 1 month to
approximately 28 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 (see Dosage and Administration
[2.2] in full Prescribing Information) 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 cytogenetic analysis. 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 laboratory abnormalities in ARIEL3 (≥25%; Grade 1–4)
were increase in creatinine (98%), decrease in hemoglobin (88%),
increase in cholesterol (84%), increase in alanine aminotransferase
(ALT) (73%), increase in aspartate aminotransferase (AST) (61%),
decrease in platelets (44%), decrease in leukocytes (44%), decrease
in neutrophils (38%), increase in alkaline phosphatase (37%) and
decrease in lymphocytes (29%).
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%).
Most common laboratory abnormalities in Study 10 and ARIEL2 (≥
35%; Grade 1–4) were increase in creatinine (92%), increase in ALT
(74%), increase in AST (73%), decrease in hemoglobin (67%),
decrease in lymphocytes (45%), increase in cholesterol (40%),
decrease in platelets (39%) and decrease in absolute neutrophil
count (35%).
Co-administration of Rubraca 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 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. You may report side effects to the FDA
at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side
effects to Clovis Oncology, Inc. at 1-844-258-7662.
Click here for full Prescribing Information and additional
Important Safety Information.
Rubraca® (rucaparib) EU 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 two
or more 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
EOC, FTC, or 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:
Haematological toxicity
During treatment with Rubraca, events of myelosuppression
(anaemia, 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 haematological 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 anaemia and neutropenia. Rubraca should be interrupted
or dose reduced according to Table 1 (see section 4.2) 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 haematologist for further
investigations.
Myelodysplastic syndrome/acute myeloid leukaemia
Myelodysplastic syndrome/acute myeloid leukaemia (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
haematologist for further investigations, including bone marrow
analysis and blood sampling for cytogenetics. If, following
investigation for prolonged haematological 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 (SPF) of 50
or greater.
Gastrointestinal toxicities
Gastrointestinal toxicities (nausea and vomiting) are frequently
reported with Rubraca, are generally low grade (CTCAE Grade 1 or
2),and may be managed with dose reduction (refer to Table 1) 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
hospitalisation.
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
section 5.3).
Pregnancy/contraception
Pregnant women should be informed of the potential risk to a
foetus. 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). A pregnancy test before
initiating treatment is recommended in women of reproductive
potential.
Click here to access the current Summary of Product
Characteristics. 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 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. 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, whether future
study results will be consistent with study findings to date and
whether future study results will support continued development or
regulatory approval. 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/20190912005326/en/
Clovis Investor Contacts: Anna Sussman, 303.625.5022
asussman@clovisoncology.com or Breanna Burkart, 303.625.5023
bburkart@clovisoncology.com Clovis Media Contacts:
U.S. Lisa Guiterman, 301.217.9353 clovismedia@sambrown.com
or Christy Curran, 615.414.8668 clovismedia@sambrown.com EU
Jake Davis, +44 (0) 20.3946.3538
Jake.Davis@publicisresolute.com
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