- Investigator Sponsored Trial sites in Australia include St. Vincent's Hospital,
Sydney, Alfred Health,
Melbourne, and the Royal Victorian
Eye and Ear Hospital, Melbourne
- Preliminary signals of clinical activity observed in the
primary uvea, including tumor shrinkage following neoadjuvant
darovasertib monotherapy treatment
- (Neo)adjuvant UM represents an unmet medical need and
potential clinical expansion opportunity with annual incidence of
approximately 8,700 patients in the US and EU
- Clinical proof-of-concept data for use in (neo)adjuvant UM
setting will be presented with the interim darovasertib Phase 2
clinical data update in MUM in September
2022
SOUTH
SAN FRANCISCO, Calif., Sept. 6,
2022 /PRNewswire/ -- IDEAYA Biosciences, Inc.
(Nasdaq: IDYA), a synthetic lethality focused precision medicine
oncology company committed to the discovery and development of
targeted therapeutics, announced that it has initiated an
Investigator Sponsored Trial, or IST, in coordination with St.
Vincent's Hospital, Sydney, to
evaluate darovasertib as monotherapy in neo-adjuvant and adjuvant
settings in primary, non-metastatic uveal melanoma (UM)
patients.
![(PRNewsfoto/IDEAYA Biosciences, Inc.) (PRNewsfoto/IDEAYA Biosciences, Inc.)](https://mma.prnewswire.com/media/820568/IDEAYA_Logo.jpg)
The study, captioned as "Neoadjuvant / Adjuvant trial of
Darovasertib in Ocular Melanoma" (NADOM), is being led by principal
investigator Professor Anthony
Joshua, MBBS, PhD, FRACP, Head Department of Medical
Oncology, Kinghorn Cancer Centre, St. Vincent's Hospital in
Sydney with participating sites of
Alfred Health and the Royal Victorian Eye and Ear Hospital in
Melbourne. Pursuant to the protocol, the NADOM study will
evaluate darovasertib as monotherapy in eligible adult patients
having ocular melanoma to determine the feasibility and
tolerability of (neo)adjuvant treatment.
"We are excited to be leading this ground-breaking clinical
study treating patients with darovasertib in the neo-adjuvant and
adjuvant settings. The concept for this study originated from
anecdotal observations in a MUM patient treated with darovasertib
who also had an intact primary lesion in the eye, where a reduction
in the eye lesion was observed at an initial scan with improvement
in visual symptoms," said Professor Anthony
Joshua, MBBS, PhD, FRACP, Head Department of Medical
Oncology, Kinghorn Cancer Centre, St. Vincent's Hospital Sydney.
"We are observing an early signal of clinical activity in the
first patient enrolled in the NADOM study," said Professor Mark
Shackleton MBBS, PhD, FRACP, Director of Oncology at Alfred Health
and Professor of Oncology, Monash University. "Our
coordinated patient care with eye specialists at the Royal
Victorian Eye and Ear Hospital on this trial has enabled a
potential paradigm-shifting approach to reduce the size of ocular
tumors prior to primary treatment, which we hope will lead to
better outcomes for patients," continued Professor Shackleton.
"There are currently limited treatment options for patients with
uveal melanoma in the pre-metastatic setting. We are pleased to be
collaborating with St. Vincent's Hospital in Sydney and with Alfred Health and Royal
Victorian Eye and Ear Hospital in Melbourne to explore the potential for
darovasertib monotherapy to be impactful for patients with primary
uveal melanoma," said Dr. Matthew
Maurer, M.D., Vice President, Head of Clinical Oncology and
Medical Affairs, IDEAYA Biosciences.
Uveal melanoma is a rare, lethal form of melanoma that arises
from melanocytes of the iris, the ciliary body, or most commonly
the choroid, with an annual potential incidence of approximately
8,700 patients aggregate in US and Europe. Current approaches
for treatment of primary UM includes radiotherapy (plaque
brachytherapy or stereotactic radiosurgery) and, for larger tumors,
enucleation of the eye, with consequential patient impact including
reduced vision, decreased depth perception, diminished social
functioning and unsatisfactory cosmesis.
Darovasertib (IDE196) is a potent, selective small molecule
inhibitor of protein kinase C (PKC). Mutations in GNAQ or
GNA11 (GNAQ/11) have been identified in approximately 90% of
patients with metastatic UM. These mutations are associated
with activation of signaling pathways, including oncogenic
RAS/RAF/MEK/ERK via Protein Kinase C (PKC) activation, driving
tumor progression. In April 2022, the
FDA designated darovasertib as an Orphan Drug in Uveal
Melanoma.
In addition to supporting the NADOM study with St. Vincent's
Hospital Sydney, IDEAYA is also evaluating the synthetic lethal
combination of darovasertib and crizotinib, a small molecule cMET
inhibitor, in metastatic uveal melanoma (MUM) in an ongoing Phase 2
clinical trial pursuant to a clinical trial collaboration and drug
supply agreement with Pfizer.
IDEAYA is targeting interim Phase 2 clinical results for
darovasertib and crizotinib synthetic lethal combination in
first-line and any-line MUM patients in September 2022, including clinical efficacy in
MUM (e.g., confirmed overall response rate by RECIST, median
progression-free survival, median duration of response) and an
adverse event summary. The company will also present data
supporting clinical proof of concept for potential use of
darovasertib in primary (neo)adjuvant UM.
About IDEAYA Biosciences
IDEAYA is a synthetic
lethality focused precision medicine oncology company committed to
the discovery and development of targeted therapeutics for patient
populations selected using molecular diagnostics.
IDEAYA's approach integrates capabilities in identifying and
validating translational biomarkers with drug discovery to select
patient populations most likely to benefit from its targeted
therapies. IDEAYA is applying its research and
drug discovery capabilities to synthetic lethality – which
represents an emerging class of precision medicine
targets.
Forward-Looking Statements
This press release
contains forward-looking statements, including, but not limited to,
statements related to (i) the potential of
darovasertib as a treatment for (neo)adjuvant uveal
melanoma and (ii) the timing and content of an additional
clinical data update for darovasertib, including
the darovasertib and crizotinib
combination and the use of darovasertib in
primary (neo)adjuvant UM. Such forward-looking statements
involve substantial risks and uncertainties that could cause
IDEAYA's preclinical and clinical development programs,
future results, performance or achievements to differ significantly
from those expressed or implied by the forward-looking statements.
Such risks and uncertainties include, among others, the
uncertainties inherent in the drug development process,
including IDEAYA's programs' early stage of
development, the process of designing and conducting preclinical
and clinical trials, the regulatory approval processes, the timing
of regulatory filings, the challenges associated with manufacturing
drug products, IDEAYA's ability to successfully
establish, protect and defend its intellectual property, the
effects on IDEAYA's business of the worldwide COVID-19
pandemic, the ongoing military conflict between Russia and Ukraine, and other matters that could affect
the sufficiency of existing cash to fund operations. IDEAYA
undertakes no obligation to update or revise any
forward-looking statements. For a further description of the risks
and uncertainties that could cause actual results to differ from
those expressed in these forward-looking statements, as well as
risks relating to the business of IDEAYA in general,
see IDEAYA's recent Quarterly Report on Form 10-Q
filed on August 15, 2022 and any
current and periodic reports filed with the U.S. Securities and
Exchange Commission.
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SOURCE IDEAYA Biosciences, Inc.