Clovis Oncology to Highlight Results from Rubraca® (rucaparib) TRITON Prostate Program at ESMO 2018 Congress
October 3, 2018
-
First presentation of initial data from Rubraca Phase 2 TRITON2
trial in advanced metastatic castration-resistant prostate cancer
(mCRPC) -
First presentation of genomic profiling data based on tumor tissue
and plasma cell free circulating tumor DNA (cfDNA) samples from the
TRITON clinical program -
Additional posters include a subset analysis of the ARIEL3 trial in
advanced ovarian cancer and a trial in progress (TIP) poster of the
ATLAS trial in advanced bladder cancer
BOULDER, Colo.–(BUSINESS WIRE)–Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that four posters
featuring data and highlighting studies from the Rubraca clinical
development program will be presented at the ESMO 2018 Congress
(European Society for Medical Oncology), 19-23 October, 2018, in Munich,
Germany. These posters include the first presentation of initial results
from the Phase 2 TRITON2 clinical trial of Rubraca, an oral, small
molecule PARP inhibitor, in advanced mCRPC, as well as genomic profiling
data based on tumor tissue and plasma cfDNA samples from patients who
were screened following progression on prior therapy for enrollment in
TRITON2 or the Phase 3 TRITON3 clinical study. Both datasets from the
TRITON clinical program have been selected for inclusion in a poster
discussion session that will be led by invited discussant Dr. Joaquin
Mateo, of the Prostate Cancer Translational Research Group, Vall
d’Hebron Institute of Oncology (VHIO), Barcelona, Spain.
TRITON2 is an international, multicenter, open-label, Phase 2 study of
Rubraca in men with advanced prostate cancer with BRCA gene
mutations (germline or somatic) or other deleterious mutations in other
homologous recombination (HR) repair genes in the metastatic
castration-resistant setting. The study is currently recruiting at
approximately 100 sites worldwide. On October 2, 2018, Clovis announced
that the U.S. Food and Drug Administration 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 (AR)-directed therapy and taxane-based chemotherapy. The FDA
granted this designation based on the initial efficacy and safety
results from TRITON2 that will be shared at the ESMO 2018 Congress.
“We look forward to presenting a first look at the TRITON2 prostate
cancer data at ESMO, with a primary focus on the BRCA mutant
population,” said Patrick J. Mahaffy, President and CEO of Clovis
Oncology. “The data and updates we will share at ESMO emphasize our
commitment to developing Rubraca beyond its initial ovarian cancer
indications.”
The four Rubraca abstracts from Clovis Oncology that have
been accepted for poster presentation at the ESMO 2018 Congress are:
Title: ARIEL3: Subgroup analysis of rucaparib in
platinum-sensitive recurrent ovarian carcinoma: effect of prior
chemotherapy regimens (abstract 947P)
Presenter: Dr.
Domenica Lorusso, Unità di Ginecologia Oncologica, Fondazione IRCCS
Istituto Nazionale dei Tumori and MITO, Milan, Italy
Session: Poster
session
Date/Time: Saturday, 20 October, 12:30–13:30 CEST
Location:
Hall A3
Title: Preliminary results from TRITON2: a phase 2 study of
rucaparib in patients with metastatic castration-resistant prostate
cancer (mCRPC) associated with homologous recombination repair (HRR)
gene alterations (abstract 793PD)
Presenter: Dr. Wassim
Abida, Memorial Sloan Kettering Cancer Center, New York, NY, USA
Session:
Poster discussion session, genitourinary tumors, prostate
Date/Time:
Sunday, 21 October, 09:15–10:30 CEST
Location: Room 14b
As
the subject of a poster discussion session, this poster will be on
display for the duration of the congress beginning at 9:00 CEST on
Saturday, 20 October 2018.
Title: TRITON: Genomic profiling of circulating tumour DNA
(ctDNA) and tumour tissue for the evaluation of rucaparib in metastatic
castration-resistant prostate cancer (mCRPC) (abstract 795PD)
Presenter:
Dr. Simon Chowdhury, Guy’s Hospital & Sarah Cannon Research Institute,
London, UK
Session: Poster discussion session, genitourinary
tumours, prostate
Date/Time: Sunday, 21 October, 09:15–10:30
CEST
Location: Room 14b
As the subject of a
poster discussion session, this poster will be on display for the
duration of the congress beginning at 9:00 CEST on Saturday, 20 October
2018.
Title: ATLAS: a phase 2, open-label study of rucaparib in
patients with locally advanced (unresectable) or metastatic urothelial
carcinoma (abstract 928TIP)
Presenter: Dr. Simon Chowdhury,
Guy’s Hospital & Sarah Cannon Research Institute, London, UK
Session:
Poster session
Date/Time: Monday, 22 October, 13:15–14:15
CEST
Location: Hall A3
Specific program times and locations are subject to change by ESMO.
Clovis’ Rubraca poster presentations will be available online at clovisoncology.com at
07:30 CEST on Saturday, 20 October, 2018.
About Rubraca® (rucaparib)
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2
and PARP3 being developed in multiple tumor types, including ovarian,
metastatic castration-resistant prostate, and bladder cancers, as
monotherapy, and in combination with other anti-cancer agents.
Exploratory studies in other tumor types are also underway. Clovis holds
worldwide rights for Rubraca. Rubraca is an unlicensed medical product
outside of the U.S. and Europe.
Rubraca EU Authorized Use
Rubraca is licensed for 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.
Click
here to access the current Summary of Product Characteristics.
Healthcare professionals should report any suspected adverse reactions
via their national reporting systems.
Rubraca U.S. FDA Approved Indications and Important Safety Information
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 a 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, 5 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 alanine
aminotransferase (ALT) (74%), increase in aspartate aminotransferase
(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 (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. 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.
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, 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, and has additional offices in San Francisco and Oakland,
California and Cambridge, UK. Please visit clovisoncology.com for
more information.
Clovis Oncology Forward-looking Statement
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 timing and pace of commencement of and enrollment in our
clinical trials, including those being planned or conducted in
collaboration with partners, and the potential results of such clinical
trials. 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, the
initiation, enrollment, timing and results of our planned clinical
trials, and the risk that final results of trials may differ from
initial or interim results. 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.
Contacts
Clovis Investor Contacts:
Anna Sussman, 303.625.5022
asussman@clovisoncology.com
or
Breanna
Burkart, 303.625.5023
bburkart@clovisoncology.com
or
Clovis
Media Contacts:
EU
Ann Hughes, +44 (0) 7956 700 790
Ann.Hughes@publicisresolute.com
or
US
Lisa
Guiterman, 301.217.9353
clovismedia@sambrown.com
or
Christy
Curran, 615.414.8668
clovismedia@sambrown.com