NEW YORK – Ideaya Biosciences said last week that it has begun a Phase I/II trial expansion of its MAT2A inhibitor IDE397 in combination with Gilead's Trop-2 directed antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) in patients with urothelial cancer harboring an MTAP deletion.
The trial in advanced MTAP-deleted solid tumors was expanded following an initial safety and efficacy data report to study the combination of IDE397 and Trodelvy in urothelial cancer. The study is also evaluating IDE397 in combination with chemotherapy. The study will enroll up to 180 patients with MTAP.
MTAP deletions occur in about 26 percent of urothelial cancer patients, Ideaya said, and there are currently no approved therapies for this patient population.
Alongside urothelial cancer, Ideaya is also studying the combination of IDE397 and Trodelvy in non-small cell lung cancer harboring an MTAP deletion in this trial. In February, Ideaya expanded its clinical study collaboration and supply agreement with Gilead to evaluate Trodelvy with IDE397 in both of these tumor types.
The firm also has ongoing studies of IDE397 as a monotherapy in MTAP-deleted NSCLC and urothelial cancer, and it has a planned combination study of IDE397 with Ideaya's PRMT5 inhibitor IDE892 that is expected to begin in the second half of this year.
Trodelvy is currently approved in the US for metastatic triple-negative breast cancer and hormone receptor-positive, HER2-negative breast cancer.