FDA Approves Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma

Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to durvalumab (Imfinzi) 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 FDA also approved the Ventana PD-L1 (SP263) Assay as a complementary diagnostic for the assessment of the programmed cell death ligand 1 (PD-L1) protein in formalin-fixed, paraffin-embedded urothelial carcinoma tissue.

Pivotal Trial

Approval was based on one single-arm trial of 182 patients with locally advanced or metastatic urothelial carcinoma whose disease progressed after prior platinum-containing chemotherapy. Durvalumab, 10 mg/kg intravenously, was administered every 2 weeks.

Confirmed objective response rate (ORR) as assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1), was 17.0% (95% confidence interval [CI] = 11.9–23.3). At the data cutoff for the ORR analysis, median response duration was not reached (range = 0.9+ to 19.9+ months). ORR was also analyzed by PD-L1 expression status as measured by the Ventana PD-L1 (SP263) Assay. Among the 182 patients studied, the confirmed ORR was 26.3% (95% CI = 17.8–36.4) in 95 patients with a high PD-L1 score and 4.1% (95% CI = 0.9–11.5) in 73 patients with a low or negative PD-L1 score.

The most common adverse reactions in at least 15% of patients were fatigue, musculoskeletal pain, constipation, decreased appetite, nausea, peripheral edema, and urinary tract infection. Grade 3–4 adverse events were seen in 43% of patients. Infection and immune-related adverse events such as pneumonitis, hepatitis, colitis, thyroid disease, adrenal insufficiency, and diabetes were also seen with durvalumab.

The recommended dose of durvalumab is 10 mg/kg, administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

Full prescribing information is available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761069s000lbl.pdf.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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