Muscle Invasive (MIBC)

AstraZeneca has announced positive interim results from the Phase III VOLGA trial evaluating perioperative durvalumab (Imfinzi) in combination with neoadjuvant enfortumab vedotin (EV) in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have declined cisplatin-based chemotherapy. The regimen demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) and overall survival […]

Atezolizumab (Tecentriq) and Tecentriq Hybreza have been FDA approved as the first ctDNA-guided adjuvant immunotherapy options for patients with MIBC following cystectomy. Using Natera’s Signatera CDx companion diagnostic to identify MRD, the Phase 3 IMvigor011 trial demonstrated significant improvements in both DFS and OS vs placebo.

Dr. Katie Murray highlights key muscle invasive bladder cancer updates ahead of the American Urological Association Annual Meeting 2026, with a focus on postoperative recovery after radical cystectomy. Dr. Murray discusses trials like GI-COFFEE, exploring simple interventions to reduce ileus, and TIDE, which evaluates home IV fluid strategies to decrease dehydration and readmissions. While systemic […]

Phase III KEYNOTE-B15 data demonstrate significant improvements in event-free survival (EFS), overall survival (OS) and pathologic complete response (pCR) rates compared with standard cisplatin-based perioperative chemotherapy. The safety profile was manageable and consistent with the known effects of each agent. Clinical Takeaway Enfortumab vedotin-ejfv + pembrolizumab is a promising option for cisplatin-eligible patients with muscle-invasive […]

On November 21, 2025, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda or Keytruda Qlex) combined with enfortumab vedotin-ejfv (Padcev) as a perioperative therapy (neoadjuvant + adjuvant) for adults with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin. This is a first-of-its-kind labeled treatment option in this setting.

Signatera-positive patients treated with atezolizumab had statistically significant improvements in disease-free and overall survival.

First positive Phase 3 trial shows perioperative immunotherapy combination addresses critical gap for cisplatin-ineligible patients.

TMT was not cost-effective at 5-year (ICER, $464,291 per QALY) or 10-year (ICER, $308,638 per QALY) time horizons despite improved quality of life.