The FDA recently approved a less-frequent, fixed dose of durvalumab at 1500 mg every 4 weeks for use in patients with metastatic urothelial carcinoma.
Guru Sonpavde, MD, director of Bladder Cancer and a physician at Dana-Farber Cancer Institute, discussed the results of the phase 3b STRONG trial in an interview during the 2021 Genitourinary (GU) Cancers Symposium. The study explored a less-frequent, fixed-dose of the PD-L1 inhibitor durvalumab (Imfinzi) at 1500 mg every 4 weeks in patients with urothelial and nonurothelial urinary tract carcinoma (UTC).
Durvalumab was approved in 2017 for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The approval was for the use of durvalumab at a dose of 10 mg/kg every 2 weeks.
In November 2020, the FDA approved the 1500 mg every 4 weeks less-frequent, fixed dose of durvalumab for all of its approved indications, including metastatic urothelial carcinoma.
In the poster for the STRONG trial shared during the GU Symposium, Sonpavde and his coauthors wrote that the study showed that, “Fixed-dose durvalumab monotherapy every 4 weeks is convenient with an acceptable safety profile in previously treated patients with UTC. Long-term safety and efficacy data reported are consistent with published studies of durvalumab and other immuno-oncology agents in this setting” (J Clin Oncol 39, 2021 [suppl 6; abstr 429]) doi: 10.1200/JCO.2021.39.6_suppl.429).