The MYTHIC trial presented at UT MD Anderson’s clinical development updates showed activity for lunresertib plus zedoresertib in platinum-resistant ovarian cancer, including a precision biomarker-driven subgroup defined by CCNE1 amplification. The program reported a 60% objective response rate at the potential recommended phase 2 dose (RP2D) in CCNE1-amplified patients. Across all dose levels in the overall population, the agent achieved an overall response rate (ORR) of 37.5%, with tumor shrinkage reported in 80% of patients. Investigators also highlighted response durability, with 37% of patients remaining on treatment for longer than 16 weeks. In the CCNE1-amplified subgroup (19 patients), the ORR rose to 60% at the potential RP2D, and the presentation indicated additional partial responses observed since the March 25, 2026 data cutoff. The FDA granted fast track designation for lunresertib plus zedoresertib for adults with CCNE1-amplified or FBXW7/PPP2R1A-deleterious platinum-resistant/refractory disease. The update strengthens the case for a biomarker-enriched path in a high-need setting where platinum resistance limits options. The next inflection points will be full confirmatory efficacy, safety characterization and whether the RP2D’s benefit-risk supports phase 2 expansion.
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