Policy & Regulation
IDEAYA Biosciences enrols first patient in Phase 1/2 trial of IDE397 and Trodelvy for MTAP-deletion non-small cell lung cancer
4 September 2025 -

US-based precision medicine oncology company IDEAYA Biosciences, Inc. (NASDAQ: IDYA) on Thursday announced the enrolment of the first patient with non-small cell lung cancer (NSCLC) in its ongoing Phase 1/2 trial evaluating IDE397, a potential first-in-class MAT2A inhibitor, in combination with Trodelvy (sacituzumab govitecan-hziy).

The study targets patients with MTAP-deletion solid tumours and follows a clinical collaboration and supply agreement with Gilead Sciences, Inc. (NASDAQ:GILD).

The trial initially focused on MTAP-deletion urothelial cancer and was expanded in April 2025 to include MTAP-deletion NSCLC. IDEAYA is serving as the study sponsor, while Gilead is providing the supply of Trodelvy. Both companies will retain commercial rights to their respective compounds in monotherapy or combination settings.

IDEAYA highlighted encouraging preliminary data from the bladder cancer cohort, while Gilead underscored the high unmet need, noting that MTAP-deletion occurs in up to 20% of NSCLC cases and lacks approved targeted therapies.

Trodelvy is already approved in more than 50 countries for second-line or later metastatic triple-negative breast cancer and in more than 40 countries for certain HR+/HER2- metastatic breast cancer patients. Its use in MTAP-deletion NSCLC and urothelial cancer remains investigational, with safety and efficacy yet to be established. IDE397 also remains unapproved in any setting.

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