IDEAYA Biosciences Reports Encouraging Clinical Data for IDE397 in MTAP-Deletion Urothelial Cancer and NSCLC

IDEAYA Biosciences, Inc. (NASDAQ:IDYA) recently disclosed significant clinical data from its Phase 1 expansion dose of IDE397 in patients with MTAP-deletion urothelial cancer and non-small cell lung cancer (NSCLC). The announcement was made during a late breaker abstract oral presentation at the 36th edition of the EORTC-NCI-AACR Symposium held in Barcelona, Spain.

IDE397, a potent and selective potential first-in-class MAT2A inhibitor, is currently in Phase 2 clinical trials targeting MTAP-deletion solid tumors. The interim Phase 1 expansion data showed promising preliminary clinical efficacy and a favorable safety profile. The data included responses from 27 evaluable patients at the expansion dose of 30 mg once-a-day (QD) of IDE397, who had been heavily pre-treated with a median of two to three prior lines of therapy.

Notable findings from the clinical data revealed an overall response rate of approximately 33%, with various confirmed responses across different patient groups. Additionally, the disease control rate stood at 93%, indicating stability or improvement in 25 of the 27 evaluable patients. The study also reported positive ctDNA molecular response rates, showcasing significant reductions in ctDNA levels, with rapid and deep responses observed in the patients.

The Company also presented a preliminary clinical case study of the combination of IDE397 and Trodelvy in MTAP-deletion urothelial cancer patients. Initial results showed a partial response in a patient with a genetic co-alteration of MTAP-deletion and a FGFR3-TACC3 fusion, along with rapid molecular responses with substantial ctDNA reduction.

The Company highlighted the urgent medical need for therapies targeting MTAP-deletion solid tumors, as there are currently no FDA-approved treatments for this patient population. IDE397 is primarily focused on urothelial cancer and NSCLC, with plans for potential expansion into other MTAP-deletion solid tumor types.

IDEAYA Biosciences is actively progressing its clinical trials with over 35 sites globally, aiming for rapid enrollment in its Phase 2 monotherapy expansion in MTAP-deletion lung and bladder cancer. The Company is also collaborating with Amgen in a Phase 1/2 trial of IDE397 and AMG 193 combination therapy in MTAP-Deletion NSCLC.

While the combination therapy of IDE397 and Trodelvy has not received regulatory approval, the Company remains optimistic about its potential. As per the forward-looking statements, IDEAYA Biosciences continues to evaluate and advance its clinical programs to address unmet medical needs in oncology.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read IDEAYA Biosciences’s 8K filing here.

About IDEAYA Biosciences

IDEAYA Biosciences, Inc, a synthetic lethality-focused precision medicine oncology company, discovers and develops targeted therapeutics for patient populations selected using molecular diagnostics in the United States. The company's products in development include IDE196, a protein kinase C inhibitor that is in Phase 2/3 clinical trials for genetically defined cancers having GNAQ or GNA11 gene mutations; IDE397, a methionine adenosyltransferase 2a inhibitor that is in Phase 1/2 clinical trials for patients with solid tumors having methylthioadenosine phosphorylase gene deletions, such as non-small cell lung, bladder, gastric, and esophageal cancers; IDE161, a poly ADP-ribose glycohydrolase inhibitor that is in Phase 1 clinical trial to treat tumors with homologous recombination deficiency (HRD), and other genetic or molecular signatures; GSK101, a Pol Theta Helicase inhibitor that is in Phase 1 clinical trial for the treatment of tumors with BRCA or other homologous recombination, and HRD mutations; and Werner Helicase inhibitors for tumors with high microsatellite instability.