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Advancing Bladder Cancer Together

Treatment of early-stage (NMIBC) and advanced (MIBC) Bladder Cancer

ESMO 2026 Updates

MIBC: VOLGA1,2: Event-Free Survival

Granted FDA Priority ReviewExpected Q4’26

In patients with cis-ineligible/refusal MIBC treated with neoadjuvant IMFINZI + neoadjuvant-only EV followed by adjuvant IMFINZI as a single agent after RC (the VOLGA Regimen):

49%Risk reduction

The VOLGA Regimen reduced the risk of an event (disease recurrence, progression, not undergoing RC, or death) by 49% vs RC alonea (HR=0.51 [95% CI: 0.38–0.67]; P<0.0001)

aNo neoadjuvant treatment; RC followed by observation and, if approved by local health authorities as SoC/available in the local market, participants could receive adjuvant nivolumab, radiation therapy, or other chemotherapeutic regimens.

VOLGA · ESMO 2026 · Event-Free Survival

MIBC: VOLGA1,2: Overall Survival

Granted FDA Priority ReviewExpected Q4’26
42%Risk reduction

The VOLGA Regimen reduced the risk of death by 42% vs RC alonea (HR=0.58 [95% CI: 0.40–0.83]; P<0.0027)

aNo neoadjuvant treatment; RC followed by observation and, if approved by local health authorities as SoC/available in the local market, participants could receive adjuvant nivolumab, radiation therapy, or other chemotherapeutic regimens.

VOLGA · ESMO 2026 · Overall Survival

MIBC: VOLGA1,2: Discontinuation Rates

Neoadjuvant Phase
7%discontinued neoadjuvant IMFINZI due to ARs
11%discontinued neoadjuvant EV due to ARs

During the neoadjuvant phase of the trial, 7% of patients discontinued neoadjuvant IMFINZI due to ARs and 11% of patients discontinued neoadjuvant EV due to ARs

Adjuvant Phase
11%discontinued adjuvant IMFINZI due to ARs

During the adjuvant phase of the trial, 11% of patients discontinued adjuvant IMFINZI due to ARs

To learn more about VOLGA, please click here:

Explore VOLGA in NEJM →
VOLGA · ESMO 2026 · Discontinuation Rates

MIBC: NIAGARA3: Histologic Subtypes in NIAGARA

In an exploratory analysis of patients in the NIAGARA trial with UC with divergent differentiation or histologic subtypes (DDHS):

16%of ITT

16% of the NIAGARA ITT had UC with DDHS

DDHS = 16% N=1063 84% Invasive UC, not otherwise specified 84% UC with squamous differentiation 8% · n=87 UC with glandular differentiation 2% · n=25 UC with other histologic subtype 5% · n=53
NIAGARA · ESMO 2026 · Histologic Subtypes

MIBC: NIAGARA3: OS in Patients With UC and DDHS

47%Risk reduction

The NIAGARA Regimenb reduced the risk of death by 47% vs neoadjuvant gem-cis alone (HR=0.53 [95% CI: 0.30–0.91]) in patients with UC and DDHS

UC WITH DDHS ITT5 NIAGARA Gem-cis NIAGARA Gem-cis n=76 n=89 N=533 N=530 Deaths, n (%) 19 (25) 39 (44) 136 (26) 169 (32) Median OS, months (95% CI) NR NR NR NR (NR–NR) (35.8–NR) (NR–NR) (NR–NR) HR (95% CI) 0.53 (0.30–0.91) 0.75 (0.59–0.93)

bOS rates at 12 and 24 months were exploratory and were not powered to determine statistical significance.

NIAGARA · ESMO 2026 · OS in UC With DDHS

NMIBC: POTOMAC4: Disease-Free Survival in Patients With Papillary Only

In an exploratory analysis of patients in the POTOMAC trial with papillary-only tumors:

44%Risk reduction

IMFINZI + BCG reduced the risk of recurrence of high-risk disease or death by 44% vs BCG alone (HR=0.56 [95% CI: 0.37–0.84])

POTOMAC · ESMO 2026 · Papillary Only

NMIBC: POTOMAC4: Disease-Free Survival in Patients With T1 Subset of Papillary Only

52%Risk reduction

In the subset of patients with papillary-only T1 tumors, IMFINZI + BCG reduced the risk of recurrence of high-risk disease or death by 52% vs BCG alone (HR=0.48 [95% CI: 0.28–0.79])

POTOMAC · ESMO 2026 · T1 Papillary Only

References

  1. IMFINZI® (durvalumab) [Prescribing Information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2026.
  2. Powles T, et al. N Engl J Med. 2026. doi:10.1056/NEJMoa2608323.
  3. Zakharia Y, et al. Presented at: ESMO Congress 2026; October 23-27, 2026; Madrid, Spain.
  4. De Santis M, et al. Presented at: ESMO Congress 2026; October 23-27, 2026; Madrid, Spain.
  5. Powles T, et al. N Engl J Med. 2024;391(19):1773-1786.
ESMO 2026 · References