- Dosed a first patient in a company-sponsored global Phase 2
clinical trial evaluating darovasertib as neoadjuvant and adjuvant
therapy in primary uveal melanoma (UM)
- Preliminary clinical activity observed in primary UM, including
tumor shrinkage in 9 of 9 patients following neoadjuvant therapy
with darovasertib as monotherapy or in combination with crizotinib,
two of whom were spared enucleation and preserved vision
- Targeting clinical data update in the fourth quarter of 2023
from the ongoing NADOM IST evaluating single-agent darovasertib as
neoadjuvant therapy in primary UM patients
- (Neo)adjuvant UM has no approved systemic therapies with an
annual incidence of ~8,700 patients and estimated prevalence of
~100,000 patients aggregate in the U.S. and Europe
SOUTH
SAN FRANCISCO, Calif., Aug. 16,
2023 /PRNewswire/ -- IDEAYA Biosciences, Inc.
(Nasdaq: IDYA), a precision medicine oncology company committed to
the discovery and development of targeted therapeutics, announced
the achievement of First-Patient-In for the company-sponsored Phase
2 clinical trial evaluating darovasertib as neoadjuvant and
adjuvant therapy in primary uveal melanoma (UM) patients.
"We are excited to dose our first patient in this Phase 2
clinical trial. Our recently reported preliminary clinical data in
the neoadjuvant setting showed compelling evidence of anti-tumor
activity – with observed tumor shrinkage in 9 patients, including
two patients who were able to avoid enucleation. These data support
further clinical evaluation of darovasertib to determine its
potential as a neoadjuvant and adjuvant therapy," said Dr.
Darrin Beaupre, Chief Medical
Officer, IDEAYA Biosciences.
"Treatment with darovasertib as a neoadjuvant therapy provides
an opportunity to save the patient's eye by avoiding enucleation or
to reduce the tumor in the eye and enable treatment with less
radiation to preserve vision. As an adjuvant therapy, the goal is
to potentially extend recurrence free survival,",
said Sreenivasa R. Chandana, M.D., Ph.D., Medical Oncologist
at The Cancer & Hematology Centers in Grand Rapids, Michigan, and an investigator of
the Phase 2 clinical trial.
IDEAYA's Phase 2 clinical trial, designated as IDE196-009
(NCT05907954), is evaluating darovasertib as monotherapy in
(neo)adjuvant uveal melanoma with potential near-term clinical
neoadjuvant endpoints such as eye preservation for large ocular
tumors and reduction in radiation dose and/or vision preservation
for small or medium ocular tumors.
Pursuant to the clinical protocol, neoadjuvant treatment of
primary UM patients will occur prior to a standard-of-care primary
interventional treatment – typically enucleation or radiation
therapy. One cohort of UM patients with large tumors will be
treated with single-agent darovasertib until maximum benefit
or six months, at which time they will undergo a primary
interventional treatment. The neoadjuvant endpoint for this
large-sized tumor cohort is eye preservation. For example, a
patient who would otherwise have undergone enucleation would
instead be eligible for radiation treatment. Another neoadjuvant
cohort of UM patients with small or medium tumors will be treated
with single-agent darovasertib until maximum benefit or six months,
at which time they will undergo a primary interventional treatment
such as radiation therapy. Neoadjuvant endpoints for this small- or
medium-sized tumor cohort include reducing the radiation dose that
the patient receives, relative to the radiation dose they would
have otherwise received without the neoadjuvant treatment, and
functional vision preservation.
In the adjuvant setting, each of the two neoadjuvant cohorts
will be treated with single-agent darovasertib for up to six months
as follow-up adjuvant therapy after the primary interventional
treatment. The adjuvant endpoints for this portion of the clinical
trial include recurrence free survival and useful vision.
IDEAYA plans to enroll patients in the company-sponsored Phase 2
clinical trial at clinical sites in the
United States, Canada, ,
Europe and Australia. This clinical trial supplements and
expands the scope of the ongoing investigator-sponsored Phase 1
clinical trial (IST) in Australia
captioned as "Neoadjuvant / Adjuvant trial of Darovasertib in
Ocular Melanoma" (NADOM). The NADOM trial 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. IDEAYA plans to present
an update of clinical data update in the fourth quarter of 2023
from the ongoing NADOM IST evaluating darovasertib as neoadjuvant
therapy in primary UM.
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 and an estimated prevalence of approximately 100,000
patients total in the U.S. 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 PKC
activation, driving tumor progression.
The FDA has designated darovasertib as an Orphan Drug in uveal
melanoma, including primary and metastatic disease under 21 C.F.R
Part 316. IDEAYA owns or controls all commercial rights in
darovasertib in UM, subject to certain economic obligations
pursuant to its exclusive, worldwide license with Novartis.
About IDEAYA Biosciences
IDEAYA is a 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 timing and content of a darovasertib
clinical program update, (ii) the potential therapeutic benefit of
darovasertib and (iii) the enrollment of study subjects in certain
geographies. 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 Quarterly Report on Form 10-Q filed on August 10, 2023 and any current and periodic
reports filed with the U.S. Securities and Exchange Commission.
Investor and Media Contact
IDEAYA Biosciences
Paul Stone
Senior Vice President and Chief Financial Officer
investor@ideayabio.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/ideaya-announces-first-patient-in-for-company-sponsored-phase-2-clinical-trial-evaluating-darovasertib-in-neoadjuvant-uveal-melanoma-301901828.html
SOURCE IDEAYA Biosciences, Inc.