Cecilia Brown

DocwireNews

A phase 2 clinical trial evaluating IDE397 has shown the treatment has &ldquo;encouraging clinical activity&rdquo; 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 &ldquo;potential first-in-class&rdquo; 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 &ldquo;priority MTAP-deletion solid tumor types for the IDE397 phase 2 monotherapy program are [UC] and NSCLC.&rdquo;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 &ldquo;achieved target drug coverage and plasma [plasma S-adenosyl-l-methionine] pharmacodynamic reduction associated with preclinical tumor regressions,&rdquo; company officials said in the news release.&ldquo;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,&rdquo; IDEAYA Biosciences Chief Medical Officer Darrin Beaupre, MD, PhD, said in a statement. &ldquo;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.&rdquo;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 &ldquo;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.&rdquo;Source: <a href="https://www.prnewswire.com/news-releases/ideaya-announces-positive-interim-phase-2-monotherapy-expansion-data-for-ide397-a-potential-first-in-class-mat2a-inhibitor-in-mtap-deletion-urothelial-and-lung-cancer-302190321.html">PR Newswire</a>

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Officials Share Update on Phase 2 Trial of IDE397 for MTAP-Deletion NSCLC, UC

Non-Small Cell Lung Cancer

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.

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