^
Association details:
Evidence:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Updated analysis with longer follow up of a phase 2a study evaluating erdafitinib in Asian patients (pts) with advanced cholangiocarcinoma (CCA) and fibroblast growth factor receptor (FGFR) alterations.

Published date:
01/18/2022
Excerpt:
Of 232 patients with CCA who underwent molecular screening, 39 (16.8%) had FGFR alterations (21 [9.1%] fusions and 19 [8.2%] mutations). Overall, 22 (9.5%) eligible pts (median age, 52 [range, 29–69] years) were enrolled and received treatment. Median follow-up was 22.4 (range, 2.3–47.0) months; median treatment duration was 6.2 (range, 1.5–35.6) months. All 22 pts received ≥1 line of prior systemic therapy and 12 (55.0%) pts had ≥2 prior lines of therapy. The ORR was 40.9% (95% CI, 20.7%–63.6%) and median time to response was 1.8 (range, 1.5–5.6) months. Median DOR was 7.3 (95% CI, 3.7–17.5) months, median PFS was 5.6 (95% CI, 3.6–12.7) months, and median OS was 40.2 (95% CI: 9.9–not estimable) months...Asian pts with advanced CCA and FGFR alterations treated with erdafitinib had durable efficacy and a manageable safety profile, supporting the earlier findings of erdafitinib benefit in this population.
DOI:
10.1200/JCO.2022.40.4_suppl.430
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
New
Source:
Title:

5302 - Preliminary Results of a Ph2a Study to Evaluate the Clinical Efficacy and Safety of Erdafitinib in Asian Patients with Biomarker-Selected Advanced Cholangiocarcinoma (CCA)

Excerpt:
Erdafitinib shows encouraging clinical activity and tolerable safety profile in Asian and EU/US pts with FGFR-altered advanced CCA with high unmet medical need.
Trial ID: