en.Wedoany.com Reported - Elevar Therapeutics announced that the first patients have been dosed in its global Phase 2 study evaluating lirafugratinib in non-cholangiocarcinoma solid tumors with FGFR2 fusions or rearrangements. The study, named ReFocus202 (Protocol ID: ELE-4008-202; NCT07359820), is an open-label, single-arm trial designed to assess the efficacy and safety of lirafugratinib in a broad range of tumors harboring FGFR2 fusions or rearrangements, with the primary endpoint being objective response rate. The first patient was dosed at Samsung Medical Center in Seoul, South Korea, and the second patient was dosed at Moffitt Cancer Center in Tampa, Florida, USA. This multicenter study will be conducted in the United States, South Korea, the United Kingdom, Spain, and France.
Elevar CEO Dong-Gun Kim stated that the company believes lirafugratinib has significant potential in a broader range of FGFR2 fusion- or rearrangement-driven tumors and is committed to making every effort to obtain meaningful study results and submit them to the FDA.
Dr. Richard Kim, Principal Investigator of ReFocus202 and Chief of Gastrointestinal Medical Oncology at Moffitt Cancer Center, noted that patients with advanced solid tumors harboring FGFR2 fusions or rearrangements, particularly those with non-cholangiocarcinoma, often have limited treatment options. This study provides an important opportunity to better understand whether the selective FGFR2 inhibitor lirafugratinib can benefit a broader patient population whose tumors are driven by FGFR2 alterations.
Lirafugratinib (RLY-4008) has received Orphan Drug Designation and Fast Track Designation from the U.S. FDA for cholangiocarcinoma. Its New Drug Application for the treatment of previously treated patients with FGFR2 fusion/rearranged cholangiocarcinoma is under FDA Priority Review, with a PDUFA date of September 27, 2026. ReFocus202 aims to confirm the potential efficacy of lirafugratinib in patients with FGFR2 fusions/rearrangements regardless of tumor tissue type. In the Phase 1/2 ReFocus study, data from 42 non-cholangiocarcinoma solid tumor patients (involving 13 tumor types) showed meaningful antitumor activity with lirafugratinib. Elevar plans to utilize this dataset along with data generated from ReFocus202 to conduct an interim analysis across at least 7 tumor types, with a minimum of 5 patients per tumor type.
Lirafugratinib is a potent, selective, oral small-molecule FGFR2 inhibitor. Preclinical studies have shown that the drug exhibits FGFR2-dependent killing in cancer cell lines and induces tumor regression in in vivo models, while demonstrating minimal inhibition of other targets. Additionally, the drug has shown potent activity against known clinically acquired resistance mutations in preclinical models.
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