NEW YORK – Ideaya Biosciences on Tuesday said it has started treating MTAP-deleted bladder cancer patients with its MAT2A inhibitor IDE397 and Gilead's TROP2 antibody-drug conjugate Trodelvy (sacituzumab govitecan-hziy) in an arm of a Phase I trial.
The multi-arm Phase I trial is evaluating several treatment strategies involving IDE397, including its monotherapy activity and its efficacy when combined with Trodelvy or chemotherapy. In the IDE397-Trodelvy arm, Ideaya will evaluate the combination's safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy in patients with MTAP-deleted advanced or metastatic bladder cancer.
In the US, Trodelvy is approved for the treatment of advanced urothelial cancer patients who have previously received platinum-containing chemotherapy and immunotherapy. About a quarter of patients have MTAP deletions in their bladder tumors.
"The MAT2A-TROP2 combination targets two distinct, yet complementary nodes in patients with MTAP-deleted urothelial cancer and has first-in-class potential to improve clinical outcomes for bladder cancer patients with poor prognosis associated with MTAP-deletion," Ideaya Chief Medical Officer Darrin Beaupre said in a statement.
South San Francisco, California-headquartered Ideaya separately announced on Monday that it will expand evaluation of IDE397 monotherapy in MTAP-deleted bladder cancer into a Phase II portion. Earlier this year, Ideaya similarly began a Phase II expansion study of IDE397 monotherapy in MTAP-deleted squamous non-small cell lung cancer. The firm will report data from these two Phase II expansion cohorts in the second half of 2024.
Amgen is also sponsoring a separate Phase I/II trial, testing IDE397 in combination with its PRMT5 Inhibitor AMG 193 in MTAP-deletion NSCLC.