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ESMO 2025 | FORAGER-1: dose optimization of LY3866288 in FGFR3-altered tumors

Alexandra Drakaki, MD, PhD, University of California, Los Angeles, CA, discusses the Phase I FORAGER-1 study (NCT05614739) of LY3866288, a potent and selective FGFR3 inhibitor, in patients with FGFR3-altered advanced solid tumors, primarily metastatic urothelial cancer. LY3866288 at 200 mg twice daily showed favorable tolerability and encouraging antitumor activity, including in those previously treated with FGFR inhibitors. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.

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Transcript

I’m excited to share the results of the FORAGER-1, which is a Phase 1 trial of LY3866288 , a novel selective FGFR3 inhibitor in metastatic urothelial cancer that is FGFR3 altered. So patients with FGFR mutations or fusions had the opportunity to participate in Cohort 1A where we underwent dose optimization. And so we found that doses above 200 milligrams twice a day are actually safe and effective...

I’m excited to share the results of the FORAGER-1, which is a Phase 1 trial of LY3866288 , a novel selective FGFR3 inhibitor in metastatic urothelial cancer that is FGFR3 altered. So patients with FGFR mutations or fusions had the opportunity to participate in Cohort 1A where we underwent dose optimization. And so we found that doses above 200 milligrams twice a day are actually safe and effective. So as part of the presentation at ESMO 2022, we looked at patients who were treated in three different dose levels, 200, 300, and 400 mg. And we actually found that there is a significant objective response rate across the three dose levels. So the objective response rate was above 30% and had an impressive disease control rate of 94% specifically on the 200 mg twice a day.

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