- ~67% eye preservation rate (6 of 9 enucleation patients) with
darovasertib monotherapy neoadjuvant uveal melanoma treatment
- Median tumor shrinkage (maximum volume change) of ~39% after 6
months
- Clinical data on additional enucleation patients and with
further follow-up from the abstract-summary cut-off date will be
presented at ASCO 2024
- Darovasertib was generally well tolerated with no drug-related
serious adverse events
- Oral presentation at ASCO 2024 scheduled for Monday, June 3, 2024 at 9:51am CDT
SOUTH
SAN FRANCISCO, Calif., May 23, 2024
/PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a
precision medicine oncology company committed to the discovery and
development of targeted therapeutics, today announced the
publication of the abstract for an oral presentation of preliminary
clinical results from its investigator-sponsored Phase 2 trial of
darovasertib, a first-in-class oral, small molecular inhibitor of
protein kinase C (PKC), as neoadjuvant/adjuvant treatment in uveal
melanoma (UM) at the 2024 American Society of Clinical Oncology
(ASCO) Annual Meeting.
Anthony Joshua, MBBS, PhD, FRACP,
Head Department of Medical Oncology, Kinghorn Cancer Centre, St.
Vincent's Hospital in Sydney, who is the leading
principal investigator of the Phase 2 study, will present the
clinical data from the Phase 2 Neoadjuvant / Adjuvant trial of
Darovasertib in Ocular Melanoma" (NADOM) study. Details of the
presentation are as follows:
- Session: Melanoma / Skin Cancers
- Title: A Phase 2 Safety and Efficacy Study of
Neoadjuvant/Adjuvant Darovasertib for Localized Ocular
Melanoma
- Date: Monday, June 3, 2024, at
9:51 AM CDT
In summary, 15 patients planned for enucleation with
localized UM were treated with darovasertib 300mg twice daily. An
initial safety cohort of 3 patients were treated for one month, and
the remaining 12 patients were treated in an expansion cohort for
up to six months as neoadjuvant treatment prior to their primary
intervention (enucleation, plaque brachytherapy or external beam
radiotherapy (EBRT)) across three Australian centers.
As of the database lock, 11 patients had completed primary
treatment, four remained on neoadjuvant treatment, and six patients
received adjuvant darovasertib after primary treatment of their UM
with three patients completing the planned six months. At that
time, approximately 67% (6 of 9 patients) had confirmed Eye Saved
(i.e., converted to plaque brachytherapy or EBRT). Median tumor
shrinkage (maximum volume change) was approximately 39% after six
months.
The darovasertib monotherapy neoadjuvant treatment was generally
well tolerated. Drug-related adverse events (AEs) were
predominantly Grade 1 or Grade 2. Thirteen percent of patients
reported at least one drug-related Grade 3 adverse event and no
drug-related serious adverse events were observed.
Additional patients and further follow up from the abstract
summary cut-off date will be presented on the June 3, 2024, ASCO oral presentation. A copy
of the ASCO oral presentation will be available at approximately
10:00am CDT at its Investor Relations
portal under "Events" (https://ir.ideayabio.com/) on the day of the
presentation.
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 the content
and timing of the ASCO oral presentation. 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, 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 Annual Report on Form
10-K dated February 20, 2024 and any
current and periodic reports filed with the U.S. Securities and
Exchange Commission.
Investor and Media Contact
IDEAYA Biosciences
Andres Ruiz Briseno
SVP, Head of Finance and Investor Relations
investor@ideayabio.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-announces-abstract-summary-results-of-asco-2024-oral-presentation-for-phase-2-investigator-sponsored-study-of-darovasertib-in-neoadjuvant-uveal-melanoma-302154551.html
SOURCE IDEAYA Biosciences, Inc.