Erdafitinib demonstrates clinical benefit in patients with advanced solid tumors

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The RAGNAR study, a phase 2 clinical trial, has demonstrated significant clinical benefit of the oral FGFR inhibitor erdafitinib in treating patients with advanced solid tumors that harbor susceptible FGFR alterations.

This study expands the potential application of erdafitinib beyond its known effectiveness in FGFR-altered advanced urothelial carcinoma, showing positive results across 16 distinct tumor types. The findings highlight erdafitinib as a promising therapeutic option for patients who have exhausted other treatment options and support the ongoing development of FGFR inhibitors for advanced solid tumors.

The RAGNAR study comprised multiple cohorts based on tumor histology and patient age. Eligible participants had already undergone at least 1 line of systemic therapy, lacked alternative standard treatments, and maintained an Eastern Cooperative Oncology Group performance status of 0-1.

During the study period, 217 patients were treated with erdafitinib. The data revealed that at a median follow-up of 17.9 months, 30% of patients (95% CI 24-36) displayed an objective response across 16 distinct tumor types.

Notable treatment-emergent adverse events included stomatitis (12%), palmar-plantar erythrodysaesthesia syndrome (6%), and hyperphosphataemia (5%), all categorized as grade 3. Serious treatment-related adverse events, also grade 3, encompassed stomatitis in 2% of patients and diarrhea in 1%, with no reported treatment-related deaths.

Pant S, Schuler M, Iyer G, et al; RAGNAR Investigators. Erdafitinib in patients with advanced solid tumours with FGFR alterations (RAGNAR): an international, single-arm, phase 2 study. Lancet Oncol. 2023;24(8):925-935. doi: 10.1016/S1470-2045(23)00275-9. PMID: 37541273.