- 75% eye preservation rate (9 of 12 enucleation
patients)
- ~67% (8 of 12 enucleation patients) observed greater than
30% tumor shrinkage and median tumor shrinkage of 47% by volume
change after 6 months
- Company-sponsored Phase 2 Neoadjuvant UM: Over 40 patients
enrolled, and for the 8 patients with ≥4-months of darovasertib
observed median tumor shrinkage of 72% by volume change and eye
preserved for the majority of enucleation patients
- Targeting Type C meeting with the FDA in H2 2024 for
guidance on potential registrational trial for darovasertib in
neoadjuvant UM setting
- Projected global annual incidence of primary UM is ~8,000 to
~10,000 patients
SOUTH
SAN FRANCISCO, Calif., June 3, 2024
/PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a
precision medicine oncology company committed to the discovery and
development of targeted therapeutics, today announced updated
clinical results from the ongoing 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) and clinical update for Phase 2
company-sponsored neoadjuvant UM study. The clinical data from the
ongoing investigator-sponsored Phase 2 trial were included in an
oral presentation at the American Society of Clinical Oncology
(ASCO) 2024 Annual Meeting.
"The clinical data presented at ASCO provides further
validation for the potential of darovasertib in the neoadjuvant UM
setting to preserve the eye and to shrink ocular tumors for UM
patients," said Yujiro S. Hata,
President and Chief Executive Officer, IDEAYA Biosciences. "We
believe neoadjuvant and adjuvant UM represent high unmet medical
needs and indication expansion opportunities that are potential
first-line treatment opportunities across the patient journey and
irrespective of HLA-A2 status that will significantly expand the
addressable patient population for darovasertib beyond the
metastatic setting."
"The clinical data presented at ASCO highlights the
potential of darovasertib as a neoadjuvant treatment to provide
meaningful tumor shrinkage in patients with ocular tumors and spare
patients from enucleation, with a manageable AE profile," added
Darrin Beaupre, M.D., Ph.D., Chief
Medical Officer, IDEAYA Biosciences. "We are targeting a Type C
meeting with the FDA in H2 2024 for guidance on a potential
registrational trial in neoadjuvant UM, and we are encouraged by
the rapid enrollment, and preliminary clinical efficacy and safety
observed from IDEAYA's company-sponsored Phase 2 neoadjuvant UM
trial."
Anthony Joshua, MBBS, PhD, FRACP,
Head Department of Medical Oncology, Kinghorn Cancer Centre, St.
Vincent's Hospital in Sydney, and the lead principal
investigator of the Phase 2 study, presented clinical results from
the Phase 2 Neoadjuvant / Adjuvant trial of Darovasertib in Ocular
Melanoma (NADOM) at ASCO. Fifteen patients planned for enucleation
with localized UM were treated with darovasertib 300mg twice daily.
An initial safety cohort of three 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 on May 14,
2024, 13 patients had completed neoadjuvant treatment, 11
patients received adjuvant darovasertib after primary treatment of
their UM, with five patients completing the planned six months of
therapy. As of May 14, 2024, 75% (9
out of 12 enucleation patients) had confirmed Eye Saved (i.e.,
converted to plaque brachytherapy or EBRT) and approximately 67% (8
out of 12 enucleation patients) observed greater than 30% tumor
shrinkage (maximum volume change) after 6 months. Median tumor
shrinkage (maximum volume change) in 12 enucleation patients was
approximately 47% after 6 months.
The darovasertib monotherapy neoadjuvant treatment had a
manageable adverse event (AE) profile with no drug-related serious
adverse events observed. Drug-related AEs were predominantly Grade
1 or Grade 2 and 20% of patients reported at least one drug-related
Grade 3 adverse event.
The Company is targeting a Type C meeting with the FDA to
discuss a potential registrational trial for darovasertib in the
neoadjuvant UM setting and a clinical efficacy update from its
Phase 2 company-sponsored darovasertib neoadjuvant UM trial in H2
2024. As of May 24, 2024 cut-off
date, the Phase 2 company-sponsored darovasertib neoadjuvant UM
trial has activated over 14 sites globally and enrolled over 40
patients. As of the cut-off date, 8 patients (6 enucleation and 2
plaque eligible) have been on darovasertib treatment for 4-months
or more and observed median tumor shrinkage (maximum
height/base/volume change) of approximately 40%/25%/72% and the
majority of the 6 enucleation patients had reported Eye Saved
(i.e., converted to plaque brachytherapy or EBRT eligible).
In the 8 patients with 4-months or more of darovasertib
treatment as of May 24, 2024,
darovasertib had a manageable AE profile with no drug-related
serious adverse events observed, and drug-related AEs were
predominantly Grade 1 or Grade 2 and approximately 13% of patients
reported at least one drug-related Grade 3 AE.
The darovasertib program has ongoing enrollment of a potential
registrational Phase 2/3 trial in first-line HLA-A2-negative
metastatic UM (MUM), and Phase 2 trials in HLA-A2 positive MUM and
neoadjuvant and adjuvant UM. Darovasertib received FDA Fast Track
designation in MUM and FDA Orphan Drug designation for the
treatment of Uveal Melanoma, including MUM. We project the global
annual incidence of primary uveal melanoma is approximately 8,000
to 10,000 patients, with the majority of patients in the U.S. and
Europe.
A copy of the ASCO oral presentation and clinical data
update from the Phase 2 company-sponsored darovasertib neoadjuvant
UM trial summarized in the Corporate Presentation will be available
on the Investor Relations section of the website at approximately
8:05am EST on Monday, June
3rd, 2024.
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
of FDA regulatory guidance, (ii) the potential therapeutic benefits
of IDEAYA therapeutics, (iii) the translation of preliminary
clinical trial results into future clinical trial results, and (iv)
the estimate of patient populations. 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
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SOURCE IDEAYA Biosciences, Inc.
