A phase 2 clinical trial evaluating IDE397 has shown the treatment has “encouraging clinical activity” in patients with heavily pretreated MTAP-deletion non-small cell lung cancer (NSCLC), as well as urothelial cancer (UC), according to an update released by IDEAYA Biosciences, Inc.
IDE397, a “potential first-in-class” MAT2A inhibitor, is under evaluation in phase 2 clinical trials as a treatment for MTAP-deletion solid tumors. There are currently no approved therapies for patients with MTAP-deletion solid tumors in the United States, according to IDEAYA Biosciences, which stated that “priority MTAP-deletion solid tumor types for the IDE397 phase 2 monotherapy program are [UC] and NSCLC.”
The data update comes from the IDE397 expansion dose of 30 mg, which patients received once a day in the phase 2 trial. The expansion dose “achieved target drug coverage and plasma [plasma S-adenosyl-l-methionine] pharmacodynamic reduction associated with preclinical tumor regressions,” company officials said in the news release.
“We are highly encouraged by the preliminary clinical efficacy and favorable safety profile observed with IDE397 at the 30-mg once-a-day expansion dose, including multiple partial responses and one complete response by [Response Evaluation Criteria in Solid Tumors v1.1] in MTAP-deletion urothelial and lung cancer patients,” IDEAYA Biosciences Chief Medical Officer Darrin Beaupre, MD, PhD, said in a statement. “In addition, at this expansion dose we observed a favorable adverse event [AE] profile with no drug-related serious [AEs] and mid-single digit percent grade 3 or higher drug-related [AEs], which we believe has the potential to enable longer-duration dosing, as well as combinations.”
The update is based on 18 evaluable patients with MTAP-deletions, including 7 patients with squamous cell NSCLC, 4 with adenocarcinoma NSCLC, and 7 with UC. The patients evaluated in the phase 2 trial received a median of 2 prior lines of therapy (range, 1-7 lines).
The study showed an overall response rate of 39%, with a 94% disease control rate. Among the 18 patients evaluated, 78% had tumor shrinkage. In addition, 81% of the patients had a circulating tumor DNA reduction of at least 50%.
The rate of grade 3 or higher drug-related AEs was 5.6% at the 30-mg expansion dose. No drug-related AEs that led to discontinuations were reported, officials said, explaining that “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.”
Source: PR Newswire
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