- ~39% Overall Response Rate (ORR): 1 CR and 6 PRs (2 awaiting confirmation)
by RECIST 1.1 out of 18 evaluable MTAP-deletion urothelial and
NSCLC patients
- ~94% Disease Control Rate (DCR): 1 CR and 6 PRs and 10 SD by
RECIST 1.1
- ~78% of Patients with Tumor Shrinkage: 14 patients observed
tumor shrinkage
- ~81% ctDNA Molecular Response Rate (MRR): 13 of 16 patients
with > 50% ctDNA reduction
- AE Profile: ~5.6% drug-related grade >3 AEs and no
drug-related SAEs or discontinuations at 30 mg once-a-day expansion
dose
- IDE397 expansion dose of 30 mg once-a-day achieved target drug
coverage and plasma SAM pharmacodynamic reduction associated with
preclinical tumor regressions
- ~48k U.S. annual incidence of MTAP-deletion urothelial cancer
and NSCLC, with high unmet need and no FDA-approved therapies for
MTAP-deletion solid tumors
- Investor webcast scheduled for today, Monday, July 8, 2024, at 8:00 am ET
SOUTH
SAN FRANCISCO, Calif., July 8, 2024
/PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a
precision medicine oncology company committed to the discovery and
development of targeted therapeutics, today announced positive
clinical data for the IDE397 Phase 2 monotherapy expansion dose in
methylthioadenosine phosphorylase (MTAP)-deletion urothelial and
non-small cell lung cancer (NSCLC) patients. IDE397 is a potent and
selective potential first-in-class methionine adenosyltransferase 2
alpha (MAT2A) inhibitor in Phase 2 clinical trials for the
treatment of MTAP-deletion solid tumors.
"We are highly encouraged by the preliminary clinical efficacy
and favorable safety profile observed with IDE397 at the 30mg
once-a-day expansion dose, including multiple partial responses and
one complete response by RECIST 1.1 in MTAP-deletion urothelial and
lung cancer patients. In addition, at this expansion dose we
observed a favorable adverse event profile with no drug-related
serious adverse events and mid-single digit percent grade 3 or
higher drug-related adverse events, which we believe has the
potential to enable longer duration dosing as well as
combinations," said Dr. Darrin Beaupre, M.D., Ph.D., Chief
Medical Officer, IDEAYA Biosciences.
"IDE397 is a potential first-in-class MAT2A inhibitor, that is
being advanced as a monotherapy agent in priority MTAP-deletion
solid tumor types and in high conviction rational combinations,
including with Amgen's investigational MTA-cooperative protein
arginine methytranferase 5 inhibitor AMG 193 in NSCLC and with
Gilead's Trop-2 directed anti-body conjugate Trodelvy in urothelial
cancer. The IDE397 clinical data update demonstrates important
clinical proof-of-concept in MTAP-deletion solid tumors to deliver
RECIST responses and encouraging preliminary durability, with a
convenient 30mg once-a-day tablet and favorable adverse event
profile," said Yujiro S. Hata, Chief
Executive Officer and Founder, IDEAYA Biosciences.
There are currently no FDA-approved therapies for patients with
MTAP-deletion solid tumors, highlighting the unmet medical need.
The priority MTAP-deletion solid tumor types for the IDE397 Phase 2
monotherapy program are urothelial cancer and NSCLC. MTAP-deletion
prevalence has been reported at over 15% in NSCLC and over 25% in
urothelial cancer, based on The Cancer Genome Atlas (TCGA)
database. We estimate that the MTAP-deletion annual incidence in
the U.S. in NSCLC and urothelial cancer is approximately 48,000
patients, based on the 2024 Surveillance, Epidemiology, and End
Results (SEER) database. In addition, there are several potential
expansion MTAP-deletion solid tumor types that are also being
considered for monotherapy and combination development, including
pancreatic, gastric, esophageal, and head and neck cancer, among
others. Based on the TCGA database, MTAP-deletion prevalence in
pancreatic cancer has been reported at over 20%, representing a
U.S. annual incidence of approximately 14,000 patients.
Clinical Data Update – IDE397 at 30mg QD Phase 2 Expansion
Dose in MTAP-Deletion Urothelial Cancer and NSCLC Patients
The company observed encouraging clinical activity at the 30 mg
expansion dose in its Phase 2 clinical trial evaluating its
potential first-in-class MAT2A inhibitor IDE397 in heavily
pre-treated MTAP-deletion urothelial cancer and NSCLC patients. The
patients evaluated had a median of two (2) prior lines of therapy,
ranging from one (1) to seven (7) prior lines of treatment. The
reported Phase 2 clinical data are based on eighteen (18) evaluable
MTAP-deletion patients, including seven (7) urothelial cancer, four
(4) adenocarcinoma NSCLC, and seven (7) squamous NSCLC patients at
the expansion dose of 30 mg once-a-day of IDE397.
Reported clinical efficacy and tolerability data are preliminary
and based on investigator review from an unlocked database as of
the data analysis cutoff date of June
21, 2024.
The clinical data update in the eighteen (18) evaluable patients
by RECIST 1.1 include:
- ~39% Overall Response Rate (ORR). One (1) complete response and six (6)
partial responses by RECIST 1.1 evaluation out of eighteen (18)
evaluable patients. Two (2) partial responses are awaiting
confirmation, including one (1) urothelial cancer patient that had
a 100% tumor reduction in the target lesion at the last CT-scan
assessment and one (1) adenocarcinoma NSCLC patient. One (1)
complete response and two (2) partial responses were urothelial
cancer patients. Among patients with lung cancer, three (3) partial
responses were squamous NSCLC patients, and one (1) partial
response was an adenocarcinoma NSCLC patient. There was one (1)
non-evaluable patient who discontinued due to rapid clinical
progression of cancer fatigue and drug-unrelated adverse events in
cycle 1 of treatment
- 94% Disease Control Rate (DCR). One (1) complete response, six
(6) partial responses, and ten (10) stable disease by RECIST 1.1
evaluation out of eighteen (18) evaluable patients
- 78% of patients with tumor shrinkage. Fourteen (14) out of
eighteen (18) evaluable patients observed tumor shrinkage
- Swim lane plot by CT-scan evaluation and preliminary durability
assessment: Eleven (11) of eighteen (18) patients still on
treatment. Five (5) of seven (7) RECIST 1.1 responses remain in
response. Median duration of treatment, median duration of
response, and median progression free survival not yet reached
- 81% ctDNA Molecular Response (MR) Rate. Thirteen (13) of
sixteen (16) patients with 50% or greater ctDNA reduction. There
were several quality control failures of patient samples that led
to unavailability for MR analysis
- Favorable adverse event (AE) profile. Approximately 5.6% grade
3 or higher drug-related AEs and no drug-related serious adverse
events (SAEs) observed at IDE397 30mg once-a-day expansion dose. No
drug-related AEs leading to discontinuations observed. We
anticipate that the favorable AE profile and dosing convenience of
a 30 mg once-a-day tablet has the potential to enable long-term
dosing and combination development
- 30mg once daily expansion dose achieves target drug coverage
and plasma S-adenosyl-l-methionine (SAM) pharmacodynamic reduction
associated with preclinical tumor regressions
IDEAYA has activated over 35 clinical trial sites globally
in the U.S., Canada, Europe, and Asia
Pacific to enable potential rapid enrollment for the IDE397
Phase 2 monotherapy expansion in MTAP-deletion lung and bladder
cancer in its ongoing trial (NCT04794699). There is also an
Amgen-sponsored Phase 1/2 trial of IDE397 and AMG 193 combination
in MTAP-Deletion NSCLC (NCT05975073) for which the companies intend
to develop a joint publication strategy in 2024. In addition,
IDEAYA has initiated enrollment in a Phase 1 clinical trial
evaluating the safety, tolerability, pharmacokinetics,
pharmacodynamics and efficacy of IDE397 in combination with
Trodelvy (NCT04794699). IDEAYA is also advancing multiple
preclinical stage MTAP-deletion programs to enable wholly-owned
combinations with IDE397, including a program targeting a
development candidate nomination in the second half of 2024.
IDEAYA Investor Webcast and Conference Call
IDEAYA will host an investor webcast today, Monday, July 8, at 8:00 am
Eastern Time (ET), to present the clinical data update for
the IDE397 Phase 2 monotherapy expansion dose in MTAP-deletion
urothelial cancer and NSCLC patients.
Presenters at the investor webcast will include IDEAYA
Biosciences management, including Yujiro S.
Hata, Chief Executive Officer, Darrin Beaupre, M.D., Ph.D., Chief Medical
Officer, and Michael White, Ph.D.,
Chief Scientific Officer.
The IDE397 investor webcast presentation, as well as an updated
corporate presentation, which will incorporate the IDE397 Phase 2
clinical data update at the 30mg expansion dose in urothelial
cancer and NSCLC patients, will be available on the company's
website, at its Investor Relations portal at approximately 8:00 am
ET on Monday, July 8, 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) expectations regarding the clinical
activity profile and potential advantages of IDEAYA's clinical
programs, (ii) the timing for the development of a joint
Amgen/IDEAYA publication strategy for the Phase 1/2 IDE397 and AMG
193 combination, (iii) the timing of preclinical stage
MTAP-deletion programs in combination with IDE397 and (iv)
nomination of an IDE397 combination development candidate in the
second half of 2024. Such forward-looking statements involve
substantial risks and uncertainties that could cause actual events
and results to differ from those expressed in these forward-looking
statements, including those related to IDEAYA's preclinical and
clinical development programs. 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, serious adverse events, undesirable side
effects or unexpected characteristics of drug development programs,
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 sufficiency of existing cash
to fund operations, and other matters that could affect the
company's business, financial condition, results of operations and
prospects. 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 events and 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 filed on February 20, 2024, Quarterly Report on Form 10-Q
filed on May 7, 2024 and any
additional 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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