This article is more than 5 years old. Information may no longer be current.
FDA grants priority review to MPDL3280A for treatment of advanced, metastatic urothelial carcinoma
Click Here to Manage Email Alerts
The FDA granted priority review to the anti–PD-L1 therapy atezolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma.
The designation relates to use of atezolizumab (MPDL3280A, Genentech) for patients who progressed during or after platinum-based chemotherapy in the metastatic setting, or for those whose disease worsened within 12 months of platinum based neoadjuvant or adjuvant chemotherapy.
The FDA granted breakthrough therapy designation to atezolizumab in May 2014 for the treatment of PD-L1–positive metastatic bladder cancer.
The FDA awarded priority review based on results of the phase 2 IMvigor 210 study, an open-label, multicenter, single-arm study that evaluated the safety and efficacy of atezolizumab in patients with locally advanced or metastatic urothelial carcinoma, regardless of PD-L1 expression.
The analysis included 311 patients whose disease progressed during or after treatment with platinum-based chemotherapy. Patients received atezolizumab 1,200 mg via IV on day 1 of each 21-day cycle. Treatment continued until the loss of clinical benefit.
Objective response rate by independent review served as the primary endpoint. Secondary endpoints included duration of response, OS, PFS and safety.
Median follow-up was 11.7 months. Results showed atezolizumab shrunk tumors in 15% (95% CI, 11-19) of study participants evaluable for efficacy and safety, as well as in 26% (95% CI, 18-36) of patients whose disease had medium or high levels of PD-L1 expression.
Median duration of response had not been reached at the time of analysis; however, 84% of participants demonstrated an ongoing response.
The most common grade 3 to grade 4 treatment-related adverse events were fatigue, decreased appetite, fever, anemia, increases in aspartate transaminase and alanine transaminase levels, joint pain, difficulty breathing, inflammation of the lung wall, inflammation of the lining of the colon, hypertension and hypotension. No treatment-related grade 5 adverse events occurred.
“The treatment options available for advanced bladder cancer are very limited, and we are committed to working with the FDA to bring the first anti–PD-L1 cancer immunotherapy to people with this disease as quickly as possible,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a press release.
The ongoing phase 3 IMvigor 211 study is designed to compare atezolizumab vs. chemotherapy in patients whose bladder cancer progressed on at least one prior platinum-containing regimen.