- Initial presentation of data from the Phase 1b part of the
LIO-1 trial of lucitanib in combination with nivolumab in advanced
metastatic solid tumors
- New data analyses for Rubraca® (rucaparib) from the Phase 2
TRITON2 and Phase 3 ARIEL3 studies in patients with metastatic
castration-resistant prostate cancer (mCRPC) and recurrent ovarian
cancer, respectively
- First presentation of preclinical data for FAP-2286, a novel
peptide-targeted radionuclide therapy (PTRT) being developed for
the treatment of a variety of cancers
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that six
e-posters highlighting clinical data from the lucitanib and
Rubraca® (rucaparib) clinical development programs, as well as
preclinical data for FAP-2286, will be presented at the ESMO
(European Society for Medical Oncology) Virtual Congress 2020,
September 19 – September 21, 2020.
E-posters for presentation include the following:
- Initial data from the Phase 1b part of the LIO-1 study in
patients with an advanced metastatic solid tumor, which aimed to
determine the recommended Phase 2 starting dose of lucitanib in
combination with nivolumab and to provide safety, pharmacokinetic
and preliminary efficacy data for the combination.
- A Trials in Progress e-poster describing the design of the
Phase 2 part of the LIO-1 study, which is now enrolling patients,
and will evaluate the combination’s safety and efficacy in patients
with an advanced gynecological solid tumor, including ovarian,
endometrial and cervical cancers.
- Analyses of pharmacokinetics and relationships between exposure
and efficacy/safety in patients with metastatic
castration-resistant prostate cancer (mCRPC) from the Phase 2
TRITON2 study of Rubraca, the primary analysis of which served as
the pivotal data supporting FDA approval of Rubraca as the first
poly-ADP ribose polymerase (PARP) inhibitor for patients with
advanced mCRPC associated with a BRCA mutation.
- New analysis of data from the Phase 3 ARIEL3 study evaluating
the prevalence, timing, and duration of adverse events for Rubraca
maintenance therapy in recurrent ovarian cancer.
- Initial data from the Phase 1b part of the Phase 1b/2 SEASTAR
study arm evaluating Rubraca in combination with sacituzumab
govitecan for the treatment of metastatic solid tumors, which aims
to evaluate the tolerability and preliminary efficacy for the
combination.
- The first presentation of preclinical data in in vivo and in
vitro models for FAP-2286, a novel peptide-targeted radionucleotide
therapy (PTRT) and imaging agent for which Clovis intends to file
imaging and treatment Investigational New Drug applications to the
FDA in late 2020.
“We have made significant progress in expanding the breadth and
depth of our oncology development portfolio, including our pipeline
compounds lucitanib and FAP-2286. We are excited to share new data
and updates for all three compounds from our clinical and
preclinical development programs at this year’s ESMO congress,”
said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We
remain committed to developing targeted therapies to better serve
patients, and believe delivering the right drug to the right
patient at the right time represents the future of cancer
therapy.”
The following abstracts will be available as e-posters for
on-demand viewing on the ESMO website at 9:00 a.m. CEST on
Thursday, September 17, 2020. The e-posters will also be available
online at www.clovisoncology.com/pipeline/scientific-presentations
once they are made available during the congress.
Lucitanib
E-poster Number 556P: Initial Clinical Experience of
Lucitanib + Nivolumab in Advanced Metastatic Solid Tumours: Data
From the Phase 1b/2 LIO-1 Study (CO-3810-101; NCT04042116) Lead
author: Dr. Erika Hamilton, Sarah Cannon Research
Institute/Tennessee Oncology, Nashville, United States of
America
E-poster Number 885TiP: LIO-1: A Phase 2 Study of
Lucitanib + Nivolumab in Patients (pts) With Gynecological Tumours
(CO-3810-101; NCT04042116; ENGOT-GYN3/AGO/LIO) Lead author:
Prof. Nicole Concin, Kliniken Essen-Mitte, Essen, Germany, and
Medizinische Universität Innsbruck, Austria
Rucaparib
E-poster Number 659P: Rucaparib Population
Pharmacokinetics (PPK) and Exposure-Response (ER) Analyses in
Patients (pts) With Metastatic Castration-Resistant Prostate Cancer
(mCRPC) in TRITON2 Lead author: Dr. Simon Chowdhury, Guy's
Hospital, London and Sarah Cannon Research Institute, London,
United Kingdom
E-poster Number 821P: Timing of Adverse Events During
Maintenance Treatment With Rucaparib for Recurrent Ovarian Cancer
in the Phase 3 ARIEL3 Study Lead author: Dr. Andrew Dean, St
John of God Subiaco Hospital, Subiaco, Australia
E-poster Number 547P: Rucaparib + Sacituzumab Govitecan
(SG): Initial Data From the Phase 1b/2 SEASTAR Study (NCT03992131)
Lead author: Dr. Timothy A. Yap, The University of Texas MD
Anderson Cancer Center, Houston, United States of America
FAP-2286
E-poster Number 571P: Preclinical Evaluation of FAP-2286,
a Peptide-targeted Radionuclide Therapy (PTRT) to Fibroblast
Activation Protein Alpha (FAP) Lead author: Dr. Dirk
Zboralski, 3B Pharmaceuticals GmbH, Berlin, Germany
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 (rucaparib) European Union (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 ≥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 SPC. Healthcare professionals
should report any suspected adverse reactions via their national
reporting systems.
Rubraca U.S. FDA Approved Indications
Ovarian Cancer
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.
Prostate Cancer
Rubraca is indicated for the treatment of adult patients with a
deleterious BRCA mutation (germline and/or somatic)-associated
metastatic castration-resistant prostate cancer (mCRPC) who have
been treated with androgen receptor-directed therapy and a
taxane-based chemotherapy. This indication is approved under
accelerated approval based on objective response rate and duration
of response. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
confirmatory trials.
Select Important Safety Information
Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML)
occur 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. For males on Rubraca treatment who have female
partners of reproductive potential or who are pregnant, effective
contraception should be used during treatment and for 3 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.
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 FAP-2286
FAP-2286 is a preclinical candidate discovered by 3B
Pharmaceuticals under investigation as a PTRT and imaging agent
targeting fibroblast activation protein alpha (FAP). FAP is highly
expressed in many epithelial cancers, including more than 90
percent of breast, lung, colorectal and pancreatic carcinomas.
Clovis is planning to submit an investigational new drug
application (IND) for FAP-2286 in the second half of 2020. Clovis
will conduct the global clinical trials and holds U.S. and global
rights, excluding Europe.
FAP-2286 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. 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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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 EU Jake Davis, +44 (0)
20.3946.3538 Jake.Davis@publicisresolute.com or Joanna Sullivan,
+44 (0) 207.173.4191 Joanna.Sullivan@publicisresolute.com
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