- Initiated Phase 2 expansion of darovasertib and crizotinib
combination in GNAQ/11 metastatic cutaneous melanoma based on
preliminary clinical efficacy observed
- Approximately 5% of cutaneous melanoma patients harbor
a GNAQ/11 mutation, with an estimated annual incidence of
~5,000 patients in the US and ~8,000 patients in the EU28 and total
prevalence of ~70,000 patients in the US and ~110,000 patients in
the EU28
- GNAQ/11 is on multiple NGS and liquid biopsy platforms,
enabling patient identification
SOUTH
SAN FRANCISCO, Calif., Oct. 16,
2023 /PRNewswire/ -- IDEAYA Biosciences, Inc.
(Nasdaq:IDYA), a precision medicine oncology company committed to
the discovery and development of targeted therapeutics, announces
initiation of a Phase 2 expansion of the darovasertib and
crizotinib combination in GNAQ/11 metastatic cutaneous
melanoma.
"We are pleased to advance the darovasertib and crizotinib
combination into a Phase 2 expansion for GNAQ/11 metastatic
cutaneous melanoma, where there are currently no FDA approved
therapies in this genetically-defined patient population
highlighting the unmet medical need," said Dr. Darrin M. Beaupre, M.D., Ph.D., Chief Medical
Officer, IDEAYA Biosciences. "As IDEAYA advances the
registrational trial for darovasertib in first-line HLA-A2-negative
metastatic uveal melanoma, it's a strategic priority to expand the
program's clinical application in multiple solid tumor settings,
including HLA-A2-positive metastatic uveal melanoma, neoadjuvant
and adjuvant uveal melanoma, and GNAQ/11 cutaneous melanoma," said
Yujiro S. Hata, Chief Executive
Officer, IDEAYA Biosciences.
"The clinical efficacy observed in a GNAQ melanoma patient that
progressed on immune checkpoint inhibitor therapies and treated in
our clinic has been durable and well tolerated. This is a very
important finding in this biomarker defined population," said
Dr. Marcus Butler, M.D., Medical
Oncologist, Tumor Immunotherapy Program, Melanoma/Skin Oncology
Site Lead at Princess Margaret Cancer Centre
in Toronto, Canada, and Ocular Melanoma Physician Task
Force of Canada Co-Lead.
The Phase 2 darovasertib and crizotinib combination expansion is
based on preliminary clinical efficacy observed in the GNAQ/11
metastatic cutaneous melanoma setting. The GNAQ/11 prevalence
in cutaneous melanoma has been reported at approximately 5% in The
Cancer Genome Atlas. The GNAQ/11 cutaneous melanoma estimated
annual incidence is approximately 5,000 patients in the US and
8,000 patients in the EU28, and the estimated total prevalence
of GNAQ/11 cutaneous melanoma is approximately 70,000 patients in
the US and 110,000 patients in the EU28. It has been reported that
approximately 12.5% to 15% of cutaneous melanoma patients have been
reported to develop metastatic disease, whereas in uveal
melanoma, a predominantly GNAQ/11 mediated cancer, the metastatic
rate has been reported at approximately 50%. In addition, based on
several metastatic cancer patient databases, including Memorial
Sloan Kettering Cancer Center (MSKCC) Impact, we project GNAQ/11
metastatic cutaneous melanoma has the potential to double or more
the annual addressable metastatic patient population of metastatic
uveal melanoma alone. In addition, GNAQ/11 mutation patients are
known to have low tumor mutational burden making these patients
less likely to benefit from immune checkpoint inhibitor
therapies.
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 uveal melanoma. These mutations are associated with
activation of signaling pathways, including oncogenic
RAS/RAF/MEK/ERK via PKC activation, driving tumor
progression.
__________
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 prevalence of GNAQ/11 mutations. 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
Andres Ruiz Briseno
Senior Vice President, Head of Finance and Investor Relations
investor@ideayabio.com
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