- Initiated Phase 2 clinical trial evaluating Darovasertib
as neoadjuvant treatment of uveal melanoma prior to primary
interventional treatment of enucleation or radiation therapy
- Clinical protocol includes neoadjuvant treatment with
Darovasertib to maximum benefit up to 6 months, primary treatment,
then up to 6 months of follow-up adjuvant therapy
- Neoadjuvant endpoints include eye preservation, reducing
radiation and vision preservation; adjuvant endpoints include
relapse free survival and useful vision
- UM represents an unmet medical need and potential
clinical expansion opportunity with annual incidence of
approximately 8,700 patients in the US and EU
- Targeting clinical data update for Darovasertib /
Crizotinib Combination in MUM in 2023, including overall survival
(OS) data
SOUTH
SAN FRANCISCO, Calif., Jan. 23,
2023 /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 enrollment
into a company-sponsored Phase 2 clinical trial to evaluate
darovasertib as monotherapy in neo-adjuvant and adjuvant settings
in primary, non-metastatic uveal melanoma (UM) patients. The
company also provided guidance for an update on its Phase 2
clinical trial evaluating darovasertib in combination with
crizotinib in metastatic uveal melanoma (MUM) patients in
2023.
"We are excited to clinically evaluate darovasertib as a
neoadjuvant and an adjuvant treatment in uveal melanoma patients.
This is a paradigm-shifting opportunity, as there are no approved
systemic therapies in these settings. The preliminary
clinical data shows clear evidence of anti-tumor activity and
supports further clinical evaluation of darovasertib to determine
its potential to either save the eye by avoiding enucleation, or to
reduce the tumor thickness in the eye, enabling treatment with less
radiation to preserve vision," said Dr. Carol Shields, M.D., Chief, Ocular Oncology
Service at Wills Eye Hospital and Professor of Ophthalmology at
Thomas Jefferson University.
"The primary tumor shrinkage we are observing from just a single
month of therapy in our investigator-sponsored NADOM study is very
promising. We are looking forward to seeing even greater
benefits in the IDEAYA-sponsored Phase 2 study where the protocol
provides for neoadjuvant treatment to maximum response," said
Professor Anthony Joshua, MBBS, PhD,
FRACP, Head Department of Medical Oncology, Kinghorn Cancer Centre,
St. Vincent's Hospital Sydney.
"We are taking a comprehensive approach to treatment of ocular
tumors. We plan to treat primary UM with darovasertib
monotherapy as neoadjuvant therapy prior to enucleation or
radiation treatments, and then as follow-up adjuvant therapy after
the primary interventional treatment. We are also preparing
to initiate a registrational clinical trial to treat patients who
develop metastatic uveal melanoma, which predominantly presents as
liver metastasis, with darovasertib in combination with
crizotinib," said Dr. Darrin M.
Beaupre, M.D., Ph.D., Senior Vice President and Chief
Medical Officer, IDEAYA Biosciences.
Darovasertib is a potent, selective small molecule inhibitor of
protein kinase C (PKC). Mutations in GNAQ or GNA11 (GNAQ/11)
or related proteins occur in approximately 95% of patients with
uveal melanoma (UM) and activate the PKC signaling pathway, driving
tumor progression. The FDA has designated darovasertib as an Orphan
Drug in Uveal Melanoma. As presented at IDEAYA's Investor
R&D Day in December 2022,
Darovasertib has demonstrated tumor shrinkage and clinical benefit
in 5 of 5 patients with an ocular tumor, including 3 UM patients
from the IST as measured by ultrasound, and 2 MUM patients with an
ocular lesion from IDEAYA's ongoing IDE196-001 clinical trial,
including 1 MUM patient as measured by PET scan, and 1 MUM patient
as measured by MRI.
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 depend on tumor size and location –
enucleation of the eye for large tumors and radiation therapy
(e.g., plaque brachytherapy) for small or medium tumors, which
consequential vision impairment.
IDEAYA has initiated a company-sponsored Phase 2 clinical trial
evaluating darovasertib as monotherapy in neoadjuvant and adjuvant
UM. Pursuant to the protocol, in one cohort UM patients with
large tumors will be treated with darovasertib until maximum
benefit or six months, at which time they will undergo a primary
interventional treatment. The endpoint for this large-tumor
cohort is eye preservation – e.g., a patient who would otherwise
have undergone enucleation is instead eligible for radiation
treatment. In another cohort, UM patients with small or
medium tumors will be treated with darovasertib until maximum
benefit or six months, at which time they will undergo radiation
therapy. Endpoints for this small- or medium-tumor
cohort include (i) reducing the radiation dose that the patient
received, relative to the radiation dose they would have otherwise
received without the neoadjuvant treatment, and (ii) functional
vision preservation. Each of the two cohorts will include up
to six months of follow-up adjuvant therapy after the primary
interventional treatment to evaluate relapse-free survival and
useful vision.
In addition to IDEAYA's Phase 2 clinical trial, the company is
also continuing to support the ongoing investigator sponsored trial
(IST), captioned as "Neoadjuvant / Adjuvant trial of Darovasertib
in Ocular Melanoma" (NADOM), led by St. Vincent's Hospital in
Sydney with participation of
Alfred Health and the Royal Victorian Eye and Ear Hospital in
Melbourne.
IDEAYA owns or controls all commercial rights in darovasertib,
subject to certain economic obligations under its exclusive,
worldwide license with Novartis.
IDEAYA is also evaluating darovasertib in combination with
crizotinib in MUM patients in a Phase 2 clinical trial. The
company is targeting a clinical data update on the darovasertib and
crizotinib combination in MUM in 2023, including overall survival
(OS) data.
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 early 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 benefits of darovasertib as a
neoadjuvant and an adjuvant treatment in uveal melanoma patients
and (ii)the initiation of a registrational clinical trial and
timing of a clinical data update for darovasertib in combination
with crizotinib in patients with metastatic uveal melanoma. 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 November 8, 2022 and any current and periodic
reports filed with the U.S. Securities and Exchange Commission.
Investor and Media Contact
IDEAYA Biosciences
Paul A. Stone
Senior Vice President and Chief Financial Officer
investor@ideayabio.com
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SOURCE IDEAYA Biosciences, Inc.