In Study TAS-120-101 (N=103), LYTGOBI demonstrated an ORR of 42% (95% CI: 32–52%), with 43 partial responses and a median DoR of 9.7 months (95% CI: 7.6–17.1).

Clinical Efficacy in FGFR2-Driven Tumors

Responses were observed in patients with FGFR2 fusions (78%) or rearrangements (22%), with a median time to response of 2.5 months. Efficacy was consistent across prior therapy lines (1–3+), including platinum-based regimens. Accelerated approval hinges on ongoing confirmatory trials to validate survival benefits. No data exist for pediatric or non-FGFR2-altered populations.