Posted: Monday, February 7, 2022
Published in The Lancet Oncology are findings from the open-label phase II BLC2001 study, which examined the safety and efficacy of erdafitinib in the treatment of locally advanced or metastatic urothelial carcinoma. Arlene O. Siefker-Radtke, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues assessed the long-term clinical outcomes with erdafitinib and found similar efficacy findings with their original trials. They also found that the 12-month median overall survival was 49% and the 24-month overall survival was 31%.
"Erdafitinib, a pan-fibroblast growth factor receptor tyrosine kinase inhibitor, was shown to be clinically active and tolerable in patients with advanced urothelial carcinoma…,” stated Dr. Siefker-Radtke and colleagues. Based on these findings, the investigators think this agent should be investigated in other settings.
A total of 2,328 patients were screened across 126 medical centers in 14 different countries. A total of 212 were enrolled, and 101 were treated with erdafitinib. Patients were treated using an 8-mg/kg up titration regimen for 28 days. The primary endpoint was confirmed objective response rate, and the secondary endpoints were progression-free survival, overall survival, safety, response rate, and pharmacokinetics.
Findings revealed that 40% of patients (95% confidence interval [CI] = 30%–49%) achieved a confirmed investigator-assessed objective response, and this was consistent with the objective response rate at the time of the primary analysis. Among the responding patients, 36% had a partial response, and 4% had a complete response. Median progression-free survival was 5.5 months (95% CI = 4.3–6.0 months) for all 101 patients, and the 12-month progression-free survival rate was 21% (95% CI = 13%–29%). Median overall survival was 11.3 months (95% CI = 9.7–15.2 months), and the 12-month overall survival rate was 49% (95% CI = 39%–59%).
Disclosure: For full disclosure of the study authors visit www.thelancet.com.