Asset / Drug

Imfinzi

Drug and asset intelligence for Imfinzi with 8 indexed intelligence signals across regulatory, clinical, competitive, and market developments.

Signals: 2
Catalysts: 6
Stage: Phase III

Sponsor company

AstraZeneca →

Mechanism of action

Immunotherapy

Recent signals(2)

RegulatoryJune 16, 2026

Imfinzi Gains US Approval for Early Bladder Cancer with BCG Combination

Imfinzi has been approved in the US as the first immunotherapy combination for BCG-naïve, high-risk non-muscle-invasive bladder cancer, showing a 32% reduction in disease recurrence, progression, or death.

ClinicalJune 16, 2026

Imfinzi + EV shows significant survival benefits in muscle-invasive bladder cancer

The Phase III VOLGA trial demonstrated that perioperative Imfinzi plus neoadjuvant EV significantly improves event-free survival and shows a favorable trend in overall survival for muscle-invasive bladder cancer.

Upcoming milestones(1)

Phase III Readout

AstraZeneca — Imfinzi

Positive data would strengthen AZ IO portfolio against Merck dominance in thoracic oncology.

October 12, 2026 · Phase III

Related catalysts(6)

Phase III Readout

AstraZeneca — Imfinzi

Positive data would strengthen AZ IO portfolio against Merck dominance in thoracic oncology.

October 12, 2026 · Phase III

Topline Data

AstraZeneca — Imfinzi

Monitor trial results and any announcements regarding interim analyses or regulatory submissions.

June 17, 2026 · N/A

Topline Data

AstraZeneca — Imfinzi

Monitor trial results and any announcements regarding efficacy and safety outcomes for the combination therapy.

June 17, 2026 · N/A

Topline Data

AstraZeneca — Imfinzi

Monitor the trial's progression and results, particularly the 6-month progression-free survival rates and any safety concerns.

June 17, 2026 · N/A

Topline Data

AstraZeneca — Imfinzi

Monitor uptake rates in clinical practice and any competitive responses from other companies targeting bladder cancer.

June 16, 2026 · N/A

Topline Data

AstraZeneca — Imfinzi

Monitor further data releases from the VOLGA trial and subsequent regulatory filings for Imfinzi and EV.

June 16, 2026 · N/A

Indications

Bladder Cancer →

Small cell lung cancer (limited stage) →

Therapeutic areas

Bladder Cancer →

Immunotherapy →

Oncology →

Oncology · Bladder Cancer →

Oncology · Hepatocellular Carcinoma →

Oncology · Immunotherapy →

Oncology · NSCLC →

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