SOUTH SAN FRANCISCO, Calif.,
Dec. 7, 2021 /PRNewswire/ -- IDEAYA
Biosciences, Inc. (Nasdaq:IDYA), a synthetic lethality focused
precision medicine oncology company committed to the discovery and
development of targeted therapeutics, provided a clinical data
update for the Phase 1/2 trial evaluating darovasertib and
crizotinib synthetic lethal combination in metastatic uveal
melanoma (MUM) patients.
"The partial responses, percentage of patients with tumor
shrinkage and disease control rate observed from the darovasertib
and crizotinib synthetic lethal combination in heavily pre-treated
MUM patients represents a new clinical efficacy benchmark and
provides an opportunity to deliver meaningful patient impact in
this high unmet medical need patient population," said Meredith McKean, M.D., Sarah Cannon Research
Institute at Tennessee Oncology, Associate Director, Melanoma and
Skin Cancer Research.
"These data provide clinical proof-of-concept for the PKC and
cMET synthetic lethal combination, and further validate IDEAYA's
synthetic lethality platform. We look forward to exploratory
evaluation of this novel PKC and cMET synthetic lethal combination
in other potential tumor settings, including GNAQ/11 skin melanoma
and MET-amplified and MET high expression tumors," said
Yujiro S. Hata, President and Chief
Executive Officer of IDEAYA Biosciences.
There are currently no FDA approved therapies for metastatic
uveal melanoma or GNAQ/GNA11 solid tumors, highlighting the high
unmet medical need. The historical overall response rate
(ORR) in metastatic uveal melanoma has generally been reported with
an ORR from approximately 0 to 5%, including: pembrolizumab
and tebentafusp (each ~5%); MEK inhibitor selumetinib in
combination with dacarbazine (3%); and cMET inhibitor cabozantinib
monotherapy (~0%).
Darovasertib (IDE196) is a small molecule, potential
first-in-class PKC inhibitor. IDEAYA is evaluating the
synthetic lethal combination of darovasertib and crizotinib, a
small molecule cMET inhibitor, pursuant to a clinical trial
collaboration and drug supply agreement with Pfizer. The
companies have agreed to support a target enrollment of
approximately 40 patients into the ongoing Phase 1/2 clinical
combination arm in MUM.
Clinical Data Update – Darovasertib and Crizotinib
Combination
At the time of the data and analyses cutoff on November 25,
2021, twenty-two (22) heavily pre-treated (91% with prior
therapies, and 59% with 2 or more prior therapies) MUM patients had
enrolled in the darovasertib and crizotinib combination arm at the
expansion dose, with sixteen (16) evaluable patients who have
received one or more tumor scans and 6 patients who are awaiting
their 1st tumor scan. Thirteen (13) patients have
received two or more tumor scans for evaluation of potential
responses. Reported data is preliminary and based on an
unlocked database. Enrollment in the darovasertib and
crizotinib combination arm of the clinical trial is
ongoing.
The company observed encouraging clinical activity in Phase 1/2
clinical trial evaluating darovasertib and crizotinib synthetic
lethal combination in metastatic uveal melanoma (MUM) patients in
the expansion dose cohort.
The preliminary interim data includes:
- 100% Disease Control Rate (DCR): 16 of 16 evaluable patients
with >1 post-baseline scan showed tumor shrinkage as determined
by target lesion size reduction;
- 31% Overall Response Rate (ORR): 4 of 13 patients with > 2
post-baseline scans had a confirmed partial response (PR) as
determined by RECIST 1.1 based on investigator or central review;
and no patients have come off-treatment prior to the 2nd
scan
- 46% of patients (6 of 13) with > 2 post-baseline scans
observed >30% tumor reduction, including one patient with an
unconfirmed PR as determined by RECIST 1.1 is awaiting follow-on
tumor scan.
These data provide clinical proof-of-concept for the
darovasertib and crizotinib synthetic lethal combination
treatment. These data also validate the company's
translational research discovery that Phase 1 clinical response to
darovasertib monotherapy associated with low cMETactivity, as
measured by gene signature score.
The darovasertib and crizotinib combination therapy has a
manageable side effect profile in MUM patients (n=22), with a low
rate of drug-related serious adverse events (SAE's); predominantly
Grade 1 or 2 drug-related adverse events. Eighteen (18) patients
experienced a drug-related AE, of which six (6) patients observed
Grade 3, and no patients observed Grade 4 or Grade 5.
Upcoming Milestones
IDEAYA has selected a darovasertib and crizotinib combination
expansion dose to support potential registrational studies.
The company is targeting regulatory feedback for potential
darovasertib and crizotinib combination registrational path in the
first half of 2022.
IDEAYA is also targeting a further clinical data readout for the
darovasertib and crizotinib combination, including median
progression free survival (mPFS) in MUM patients, in the first half
of 2022.
Darovasertib Expansion Opportunities
IDEAYA is also evaluating other indications as potential
expansion opportunities, including GNAQ/11 mutant skin melanoma
being evaluated in an ongoing arm of the current clinical trial,
and adjuvant uveal melanoma (UM) that the company anticipates will
be initiated through an investigator sponsor clinical trial (IST)
in the first half of 2022. The company also has exploratory
evaluation ongoing of the PKC-cMET synthetic lethal hypothesis in
additional tumor settings with MET-amplification and MET high
expression, such as hepatocellular carcinoma (HCC).
IDEAYA Investor Day – Webcast and Conference Call
IDEAYA will host an Investor Day webcast and conference call
this morning, December 7, 2021 at
8:30 am ET, to present darovasertib
and crizotinib Phase 1/2 clinical efficacy and tolerability data,
as well as clinical landscape, potential registrational strategies
and expansion opportunities. Presenters at the Investor Day
will include Dr. Meredith McKean,
M.D., Sarah Cannon Research Institute at Tennessee Oncology,
Associate Director, Melanoma and Skin Cancer Research, a key
opinion leader and clinical investigator. Yujiro S. Hata, President and Chief Executive
Officer, and other members of the IDEAYA management team will also
present.
Corporate Updates
IDEAYA's Darovasertib Investor Day presentation, as well as an
updated corporate presentation, will be available on the company's
website, at its Investor Relations portal
(https://ir.ideayabio.com/) following the Investor Day event at
approximately 10:30am ET.
IDEAYA had cash, cash equivalents and marketable securities of
approximately $386 million as of
September 30, 2021, which it believes
will fund its planned operations into 2025.
About IDEAYA Biosciences
IDEAYA is a synthetic lethality focused precision medicine
oncology company committed to the discovery and development of
targeted therapeutics for patient populations selected using
molecular diagnostics. IDEAYAs 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 future
patient impact of the darovasertib and crizotinib combination, (ii)
the evaluation of the darovasertib and crizotinib combination in
additional tumor settings, (iii) the timing of obtaining regulatory
feedback for potential darovasertib and crizotinib combination
registrational path, (iv) the timing of a further clinical
data readout for the darovasertib and crizotinib combination, (v)
the timing of initiation of an IST to evaluate darovasertib
in adjuvant uveal melanoma and (vi) the extent to which IDEAYA's
existing cash, cash equivalents, and marketable securities will
fund its planned operations. 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, the effects on IDEAYA's business of the worldwide
COVID-19 pandemic, 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 recent Quarterly Report
on Form 10-Q filed on November 15,
2021 and any current and periodic reports filed with the
U.S. Securities and Exchange Commission.
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SOURCE IDEAYA Biosciences, Inc.