(Bladder Cancer) Durvalumab Receives FDA Approval
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- May 29, 2017
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On May 1, 2017, UK-based AstraZeneca announced that durvalumab, an anti-PD-L1 antibody, received FDA accelerated approval for previously treated patients with advanced bladder cancer — marking the first-ever approval for this drug. The press release was titled: "AstraZeneca's Imfinzi (durvalumab) receives US FDA accelerated approval for previously treated patients with advanced bladder cancer."
The approved indication covers patients with advanced or metastatic urothelial carcinoma (mUC) who have received prior platinum-based chemotherapy, as well as patients with urothelial carcinoma who received platinum-based therapy in the neoadjuvant or adjuvant setting. Notably, the approval was not restricted by PD-L1 expression level.
The basis for approval was the Phase 1/2 STUDY 1108 clinical trial, which demonstrated rapid and durable antitumor activity. Among 182 patients enrolled, the objective response rate was 17.0% (95% CI: 11.9–23.3): complete response 2.7% (n=5), partial response 14.3% (n=26), with a median duration of response not yet reached (range: 0.9+–19.9+).*1 The median time to response was 6 weeks. Of the 31 responders, 14 (45%) maintained response for ≥6 months and 5 (16%) maintained response for ≥12 months.
For those interested in PD-L1 subgroup data: the objective response rate was 26.3% (95% CI: 17.8–36.4) among 95 patients with high PD-L1 expression, 4.1% (95% CI: 0.9–11.5) among 73 patients with low or negative PD-L1 expression, and 21.4% (95% CI: 4.7–50.8) among 14 patients with indeterminate PD-L1 status.*2
*1: "Not reached" means that fewer than half of patients have died at the time of analysis, so the median survival cannot yet be calculated.
*2: PD-L1 was measured using VENTANA PD-L1 (SP263).
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