Why pCR is not the whole story in cisplatin-ineligible MIBC

Perioperative durvalumab (Imfinzi) plus neoadjuvant enfortumab vedotin-ejfv (EV, Padcev) offered patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or decline cisplatin an adjuvant phase without EV, according to Alexandra Drakaki, MD, PhD, a senior investigator of the phase 3 VOLGA trial (NCT04960709) presented at the 2026 European Society for Medical Oncology Congress.¹^,2

Drakaki, an associate professor of hematology/oncology at the University of California, Los Angeles, discussed the study during a recent conversation with Joshua J. Meeks, MD, PhD, is the Edward M. Schaeffer, MD, PhD Professor of Urology and an associate professor of urology, biochemistry, and molecular genetics at Northwestern University Feinberg School of Medicine in Chicago, Illinois.

VOLGA was designed before the COVID-19 pandemic for patients who historically went directly to cystectomy, despite worse outcomes than patients who received neoadjuvant therapy. Patients were assigned to 1 of 3 arms:

• 3 cycles of neoadjuvant durvalumab plus EV, then cystectomy and adjuvant durvalumab alone to complete 1 year

• the same regimen with tremelimumab (Imjudo), given as 3 total doses including 1 adjuvant dose

• cystectomy followed by observation, later amended to allow adjuvant nivolumab (Opdivo) where available

Approximately 75% of patients were cisplatin ineligible and 25% declined cisplatin.¹

Investigators were not concerned about omitting adjuvant EV.