Clovis Oncology Announces First Patient Enrolled in the Phase 2 Portion of the LIO-1 Trial Evaluating the Combination of Luci...
August 05 2020 - 8:05AM
Business Wire
- Initial Phase 1b data from LIO-1 to be presented at the ESMO
Virtual Congress 2020
- The LIO-1 trial is part of Clovis Oncology’s broad clinical
collaboration with Bristol Myers Squibb
Clovis Oncology, Inc. (NASDAQ: CLVS) announced today treatment
of the first patient in the Phase 2 portion of the LIO-1 trial
evaluating the combination of lucitanib, Clovis’ investigational
angiogenesis inhibitor, including vascular endothelial growth
factor receptors 1 through 3 (VEGFR1-3), and Opdivo® (nivolumab),
Bristol Myers Squibb’s PD-1 inhibitor, for the treatment of
gynecologic cancers. The LIO-1 trial is sponsored by Clovis as part
of its broad clinical collaboration with Bristol Myers Squibb.
“The Phase 2 part of the LIO-1 trial will advance our scientific
understanding of the potential for an inhibitor of multiple
tyrosine kinases, including VEGF, such as lucitanib, to be combined
with a PD-1 inhibitor for the treatment of gynecologic cancers,”
said Dr. Erika Hamilton, Director of the Breast and Gynecologic
Research Program, Sarah Cannon Research Institute at Tennessee
Oncology. “It is estimated that nearly 100,000 women will be
diagnosed with a gynecologic cancer in the U.S. this year alone,
and it is vital that we identify new treatment options, in
particular new combinations, for these women.”
The Phase 2 part of LIO-1 is an open-label study to evaluate the
safety and efficacy of lucitanib and Opdivo in patients with
advanced gynecological solid tumors, including a broad spectrum of
ovarian and endometrial subtypes including clear cell disease and
patients with cervical cancer. The primary endpoint is confirmed
best overall response rate based on investigator assessment
according to Response Evaluation Criteria in Solid Tumors (RECIST)
v1.1. The study will be conducted in the U.S. and Europe, in
collaboration with the European Network for Gynaecological
Oncological Trial groups (ENGOT) for European study sites.
The Phase 2 dosing regimen for the LIO-1 study is based on
results from the recently completed Phase 1b dose-escalation
portion of the LIO-1 study. Abstracts describing the initial
results of the Phase 1b portion of the LIO-1 study, as well as a
trials-in-progress description of the Phase 2 study design of
LIO-1, have been accepted as ePosters at the European Society for
Medical Oncology (ESMO) Virtual Congress 2020 in September.
“The initiation of the Phase 2 stage of the LIO-1 clinical trial
is an important milestone for the lucitanib development program,
and I am grateful to our team and our investigators for their
commitment to initiating this study safely and expeditiously in
this new COVID-19 era,” said Patrick J. Mahaffy, President and
Chief Executive Officer of Clovis Oncology. “Importantly, we look
forward to sharing initial Phase 1b data from LIO-1 at the upcoming
virtual ESMO Congress, as well as data for each of our commercial
and development-stage products. We are committed to pursue
innovative clinical studies, both monotherapy and in combination,
that are supported by a strong scientific rationale and offer the
potential to provide additional treatment options with meaningful
clinical benefit to a broad group of cancer patients.”
More information about the LIO-1 trial (NCT04042116) is
available here.
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 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,
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; please visit
www.clovisoncology.com for more information, including additional
office locations in the U.S. and Europe.
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 potential benefit of our drug candidate
lucitanib in combination with nivolumab and expanding treatment
options for a broader set of patient populations. 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 pre-clinical or clinical
study results will support continued development or regulatory
approval, whether our clinical development programs for our drug
candidates and those of our partners can be completed on time or at
all, whether future study results will be consistent with study
findings to date, and actions by the FDA, the EMA or other
regulatory authorities regarding data required to support drug
applications and whether to accept or approve drug applications
that may be filed, as well as their decisions regarding drug
labeling, reimbursement and pricing, and other matters that could
affect the development, approval, availability or commercial
potential of our drug candidates. 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
Europe Jake Davis, +44 (0) 203.946.3538
Jake.Davis@publicisresolute.com or Joanna Sullivan, +44 (0)
207.173.4191 Joanna.Sullivan@publicisresolute.com
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