Patients with locally advanced/metastatic urothelial carcinoma (UC) may experience clinical benefit with durvalumab, according to a study published in JAMA Oncology.1
Patients with relapsed stage IV UC after chemotherapy experience poor outcomes, and there is a lack of well-established second line therapies that provide clinical benefit for this patient population. A previous interim analysis of this study demonstrated that durvalumab is well tolerated and has antitumor effects for UC.
For this phase 1/2 clinical study (ClinicalTrials.gov Identifier: NCT01693562), researchers identified 191 patients with advanced/metastatic UC and administered intravenous durvalumab 10 mg/kg every 2 weeks.
At median overall follow-up of 5.78 months, the ORR was 17.8% (95% CI, 12.7%-24.0%), including 7 complete responses. The median time to response was 1.41 months and median duration of response was not reached by follow-up. Early and durable response to therapy were observed in patients regardless of high and low (ORR, 27.6%; 95% CI, 19.0%-37.5) or negative (ORR, 5.1%; 95% CI, 1.4%-12.5%) programmed-cell-death-ligand-1 (PD-L1) expression.
The median progression-free survival was 1.5 months (95%, 1.4-1.9 months). Overall survival was 18.2 months (95% CI, 8.1-not estimable), and the 1-year overall survival rate was 55% (95% CI, 44%-65%).
Grade 3 to 4 treatment-related AEs occurred in 6.8% of patients, and grade 3 to 4 immune-mediated AEs occurred in 2.1% of patients. Treatment related adverse events (AE) led to discontinuation for 1.6% of patients, and 2 patients who experienced immune-mediated AEs died.
The study authors concluded by saying that the early clinical efficacy and favorable safety profile of durvalumab “have formed the basis for its recent regulatory approval and positioning as a standard of care (alongside atezoluzumab and nivolumab) in this setting.”
- Powles T, O’Donnell PH, Massard C, et al. Efficacy and safety of durvalumab in locally advanced or metastatic urothelial carcinoma [published online August 17, 2017]. JAMA Oncol. doi: 10.1001/jamaoncol.2017.2411