- Eye preservation reported for the first UM patient treated with
darovasertib monotherapy under the amended IST protocol enabling
neoadjuvant treatment up to 6 months
- Patient experience shared in an exclusive news report by
medical reporter Gabriella Rogers of
Television 9 News Channel station in Sydney, Australia on June 21, 2023
- Multiple additional UM patients enrolled in enucleation cohort
of Phase 1 IST in Australia, led
by clinical investigator Professor Anthony
Joshua
- Clinical sites being activated globally for IDEAYA-sponsored
Phase 2 study evaluating darovasertib monotherapy as neoadjuvant
and adjuvant therapy in UM
SOUTH
SAN FRANCISCO, Calif., June 22,
2023 /PRNewswire/ -- IDEAYA Biosciences, Inc.
(Nasdaq:IDYA), a precision medicine oncology company committed to
the discovery and development of targeted therapeutics, announced a
first reported case of a uveal melanoma (UM) patient who was
treated with single agent darovasertib as neoadjuvant therapy and
was spared enucleation in an Investigator Sponsored Trial
(IST).
"We are very excited to explore the potential of darovasertib as
neoadjuvant and adjuvant therapy for patients with ocular melanoma.
This case suggests that treatment with darovasertib as
monotherapy can preserve the eye and may have vision-sparing
utility as well as quality of life benefits," said Professor
Anthony Joshua, MBBS, PhD, FRACP,
Head Department of Medical Oncology, Kinghorn Cancer Centre, St.
Vincent's Hospital in Sydney, a
principal investigator in the IST. The IST, captioned as
"Neoadjuvant / Adjuvant trial of Darovasertib in Ocular Melanoma"
(NADOM), also includes participating sites of Alfred Health and the
Royal Victorian Eye and Ear Hospital in Melbourne.
"Avoiding enucleations with darovasertib is a very promising
development in the field of ocular oncology. We are looking forward
to further research and trials using this approach," said Dr.
William Glasson, MBBS, FRANZCO, Terrace Eye Center,
Brisbane, Australia, who was the
treating ophthalmologist for the first reported case of spared
enucleation on darovasertib monotherapy.
In the reported case, the UM patient observed a 24% reduction in
tumor size following four months of neoadjuvant treatment with
darovasertib as monotherapy. The reduction in tumor size
enabled plaque brachytherapy as a primary interventional
treatment rather than originally planned enucleation. This UM
patient shared his experience in an exclusive interview and report
by medical reporter Gabriella Rogers
of Television 9 News Channel station in Sydney Australia on June 21, 2023. See
link: https://www.9news.com.au/national/eye-cancer-melanoma-drug-trial-darovasertib-st-vincents-hospital/da15cb33-47fc-4ce8-b1ef-247e1327c6a3.
The eye preservation was observed in the first UM patient
treated under the amended protocol of the NADOM study. Pursuant to
the protocol, uveal melanoma patients who would otherwise undergo
enucleation are instead treated with single agent darovasertib as
neoadjuvant treatment for up to six months or maximum benefit –
reflecting an increase in potential treatment duration versus the
initial approach of one month neoadjuvant therapy. Multiple
additional UM patients are also enrolled in the Phase 1 NADOM study
under the amended protocol.
IDEAYA is initiating clinical sites to support a
company-sponsored Phase 2 clinical trial, designated as IDE196-009
(NCT05907954), to evaluate darovasertib as monotherapy in
(neo)adjuvant uveal melanoma with potential near-term clinical
endpoints such as organ preservation (avoiding enucleation) for
large ocular tumors and reduction in radiation dose and/or vision
preservation for small or medium ocular tumors. The Phase 2
clinical trial plans to enroll patients in U.S., Europe and Australia.
IDEAYA previously reported preliminary clinical activity
observed in primary uveal melanoma, including tumor shrinkage in 9
of 9 patients following therapy with darovasertib as monotherapy or
in combination with crizotinib, and an initial reported patient who
was spared an enucleation following neoadjuvant treatment with the
combination under a compassionate use protocol.
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 and an estimated prevalence of ~100,000
patients aggregate in the U.S. and Europe. UM has no approved systemic
neoadjuvant or adjuvant therapies. Current approaches for treatment
of primary UM includes radiotherapy (plaque brachytherapy or
stereotactic radiosurgery) and, for larger tumors, enucleation of
the eye, with consequential patient impact including reduced
vision, decreased depth perception, diminished social functioning
and unsatisfactory cosmesis.
Darovasertib (IDE196) is a potent, selective small molecule
inhibitor of protein kinase C (PKC). The FDA has designated
darovasertib as an Orphan Drug in Uveal Melanoma, including primary
and metastatic disease under 21 C.F.R Part 316. IDEAYA owns or
controls all commercial rights in darovasertib in UM, subject to
certain economic obligations pursuant to its exclusive, worldwide
license with Novartis.
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 potential therapeutic benefits of
darovasertib and (ii) the enrollment of study subjects in certain
geographies. 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
May 9, 2023 and any current and
periodic reports filed with the U.S. Securities and Exchange
Commission.
Investor and Media Contact
IDEAYA Biosciences
Paul Stone
Chief Financial Officer
investor@ideayabio.com
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SOURCE IDEAYA Biosciences, Inc.