- Independent Data Monitoring Committee (IDMC) recommends
move-forward dose in Part 2a of potential registration-enabling
trial in 1L HLA-A2-Negative MUM, based on clinical efficacy and
safety observed
- Over 185 patients enrolled in potential registration-enabling
trial in 1L HLA-A2-Negative MUM, and the darovasertib and
crizotinib combination has received U.S. Food and Drug
Administration (FDA) Fast Track designation in MUM
SAN
FRANCISCO, Dec. 17, 2024 /PRNewswire/ -- IDEAYA
Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology
company committed to the discovery and development of targeted
therapeutics, today announced the Independent Data Monitoring
Committee (IDMC) recommendation of a move-forward dose and the
completion of the Part 2a dose optimization consistent with the
U.S. Food and Drug Administration's (FDA) Project Optimus
guidelines for the potential registration-enabling Phase 2/3 trial
evaluating the combination of darovasertib and crizotinib in the
first-line (1L) setting in patients with HLA-A2-negative
(HLA-A2(-)) metastatic uveal melanoma (MUM).
"We are pleased with the recommendation of the IDMC and the
selection of the move-forward dose for our potential
registration-enabling trial evaluating the darovasertib and
crizotinib combination in first-line HLA-A2(-) MUM patients. This
allows us to complete the Part 2a portion of the study and
seamlessly continue to enroll in Part 2b towards a potential accelerated approval based
on the primary endpoint of median progression free survival," said
Darrin M. Beaupre, M.D., Ph.D.,
Chief Medical Officer, IDEAYA Biosciences.
"The combination of darovasertib and crizotinib as first-line
treatment has shown compelling preliminary clinical results in
patients with HLA-A2(-) MUM. The IDMC recommendation of the
move-forward dose supports the advancement of this potentially
registration-enabling Phase 2/3 trial and is an important step in
bringing a new treatment option to patients with MUM. Additionally,
the continued rapid enrollment further validates the strong
interest from physicians and patients, and highlights the
significant unmet need in these patients, who historically have
faced a poor prognosis," added Meredith
McKean, M.D., MPH, Director, Melanoma and Skin Cancer
Research at Sarah Cannon Research Institute, and clinical
investigator on the potential registration-enabling clinical
trial.
The darovasertib and crizotinib combination in MUM has FDA Fast
Track designation and is currently being evaluated in two clinical
trials: a potentially registration-enabling Phase 2/3 trial of
darovasertib and crizotinib combination in first-line HLA-A2(-) MUM
(NCT05987332) and a Phase 2 trial (NCT03947385). Additionally,
darovasertib as neoadjuvant monotherapy is currently being
evaluated in a Phase 2 trial in primary uveal melanoma
(NCT05907954). IDEAYA is also finalizing a clinical trial protocol
and is targeting to initiate a potential Phase 3
registration-enabling study for neoadjuvant uveal melanoma patients
in the first half of 2025.
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 progress of the clinical development
of the darovasertib and crizotinib combination in first-line HLA-A2
(-) MUM trial, (ii) the potential clinical efficacy, safety and
therapeutic benefit of the darovasertib/crizotinib combination
(iii) the registrational trial enrollment schedule of
darovasertib/crizotinib combination in MUM (iv) the US FDA Fast
Track designation and potential accelerated approval of the
darovasertib/crizotinib combination in MUM; (v) the unmet need of
patients with HLA-A2(-)MUM; (vi) the development progress of Phase
2 trials of darovasertib as neoadjuvant monotherapy in primary
uveal melanoma; (vii) the timing of initiating a potential Phase 3
registration enabling study for neoadjuvant uveal melanoma patients
in the first half of 2025. 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.