IDEAYA Biosciences Announces Proffered Paper Oral Presentation at ESMO 2023 for Phase 2 Clinical Data Update for Darovasertib and Crizotinib Combination in Metastatic Uveal Melanoma

Rhea-AI Summary

IDEAYA Biosciences announces the publication of abstract for a proffered paper session at ESMO 2023, presenting clinical data from Phase 2 trial of darovasertib in combination with crizotinib in metastatic uveal melanoma (MUM).

Positive

• The Phase 2 trial of darovasertib and crizotinib in MUM patients showed a manageable safety profile and superior clinical efficacy compared to current standards of care.
• Clinical efficacy was observed in both HLA-A2 positive and negative patients.
• ctDNA was reduced in almost all patients and molecular responses were deep and sustained in the majority of patients.
• The data support IDEAYA's ongoing registrational Phase 2/3 study for potential accelerated approval of darovasertib and crizotinib for treatment of first-line HLA-A2(-) MUM patients, where there are no FDA approved therapies.

Negative

• None.

• Proffered paper oral presentation at ESMO 2023 scheduled for Monday, October 23, 2023, at 8:50 am CEST will be presented by Dr. Meredith McKean, Sara Cannon Research Institute
• Darovasertib and Crizotinib combination observed manageable safety profile and clinical efficacy that appears superior to current standard of care in MUM
• Clinical data update, will include confirmed ORR by RECIST 1.1 by HLA-A2 status, median progression free survival, HLA-A2(+) and (-) status prevalence across darovasertib clinical trials, and ctDNA molecular response rate
• Press release summarizing the top-line results will be available on Monday, October 23, 2023, at approximately 6:00 am ET

SOUTH SAN FRANCISCO, Calif., Oct. 17, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announces the publication of the abstract for a proffered paper session at the European Society of Medical Oncology Congress 2023 (ESMO 2023) relating to selected clinical data from the company's ongoing Phase 2 clinical trial evaluating darovasertib in combination with crizotinib in patients having metastatic uveal melanoma (MUM).   

Dr. Meredith McKean, M.D., MPH, Director, Melanoma and Skin Cancer Research at Sarah Cannon Research Institute, who is a clinical investigator on the Phase 2 clinical trial, will present the clinical data as summarized in the abstract, as follows:

• Session No. 1081O
• Title: ctDNA reduction and clinical efficacy of the darovasertib + crizotinib (Daro + Crizo) combination in metastatic uveal melanoma (MUM)
• Date: Monday, October 23, 2023 at 8:50-9:00 am CEST
• Dr. Meredith McKean, M.D., MPH, Sarah Cannon Research Institute (Nashville, TN, U.S.A)

In summary, the Phase 2 evaluation of the darovasertib and crizotinib combination in first-line and pretreated MUM patients showed a manageable safety profile and demonstrated clinical efficacy that appears superior to current standards of care. Human leukocyte antigen (HLA)-A*02:01 (HLA-A2) status was determined in a subset of patients enrolled in the company's clinical trials evaluating darovasertib. Clinical efficacy was observed in both HLA-A2 positive (HLA-A2(+)) and HLA-A2 negative (HLA-A2(-)) patients. ctDNA was reduced in almost all patients and ctDNA molecular responses were deep and sustained in the majority of patients. 

The reported data support IDEAYA's ongoing registrational Phase 2/3 study for potential accelerated approval of darovasertib and crizotinib for treatment of first-line HLA-A2(-) MUM patients, where there are no FDA approved therapies.

A press release summarizing the top-line results will be available on Monday, October 23, 2023, at approximately 6:00 am ET, and will be available on the Company's website, at its Investor Relations portal (https://ir.ideayabio.com/).

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 timing and content of the ESMO 2023 presentation and related press release. 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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SOURCE IDEAYA Biosciences, Inc.

FAQ

What is the clinical data presented at ESMO 2023?

The clinical data presented at ESMO 2023 is from a Phase 2 trial evaluating darovasertib in combination with crizotinib in metastatic uveal melanoma (MUM) patients.

What were the results of the Phase 2 trial?

The Phase 2 trial showed a manageable safety profile and superior clinical efficacy compared to current standards of care.

Were there any specific patient groups that showed clinical efficacy?

Clinical efficacy was observed in both HLA-A2 positive and negative patients.

What were the findings related to ctDNA?

ctDNA was reduced in almost all patients and molecular responses were deep and sustained in the majority of patients.

What does the data support?

The data support IDEAYA's ongoing registrational Phase 2/3 study for potential accelerated approval of darovasertib and crizotinib for treatment of first-line HLA-A2(-) MUM patients, where there are no FDA approved therapies.