FDA Approves Durvalumab Plus Enfortumab Vedotin for Cisplatin-Ineligible MIBC

The FDA has approved durvalumab (Imfinzi) in combination with enfortumab vedotin-ejfv (Padcev) as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after radical cystectomy, for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or who have refused cisplatin-based chemotherapy.

The regulatory decision was supported by data from the phase 3 VOLGA trial (NCT04960709), which demonstrated that patients treated the durvalumab/ enfortumab vedotin regimen experienced a median event-free survival (EFS) that was not reached (NR; (95% CI, 33.2-NR) vs 12.1 months (95% CI, 7.6-27.0) ifor patients who underwent radical cystectomy alone (HR, 0.51; 95% CI, 0.38-0.67; two-sided P < .0001).

Adverse effects reported in more than 20% of patients in the experimental arm included increased AST levels, increased ALT levels, decreased hemoglobin levels, rash, increased creatinine levels, pruritus, decreased calcium levels, increased lipase levels, increased potassium levels, urinary tract infection, increased amylase levels, fatigue, decreased sodium levels, decreased lymphocyte counts, diarrhea, decreased leukocyte counts, constipation, decreased appetite, increased alkaline phosphatase levels, dysgeusia, nausea, peripheral neuropathy, musculoskeletal pain, and alopecia.