Glossary
Disease-free survival (DFS): time after treatment during which a patient lives without any signs or symptoms of cancer returning.
Overall survival (OS): time from treatment start or diagnosis until death from any cause.
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Imfinzi Plus BCG Improves Disease-Free Survival in High-Risk NMIBC
October 17, 2025
Paige Britt
Paige Britt
Adding Imfinzi to Bacillus Calmette-Guérin therapy improved disease-free survival for patients with high-risk, non-muscle invasive bladder cancer.
Adding Imfinzi (durvalumab) to Bacillus Calmette-Guérin (BCG) therapy helped patients with high-risk, non-muscle invasive bladder cancer live longer without their cancer returning compared with BCG alone, according to results from a phase 3 study presented at the 2025 ESMO Congress.
The findings were presented by Dr. Maria De Santis, associate professor at the University of Warwick Medical School in Coventry, England, and simultaneously published in The Lancet.
The open-label, randomized study included 1,018 patients who were assigned in 3 cohorts: 339 received 1 year of Imfinzi with BCG induction and maintenance therapy, 339 received one year of Imfinzi with BCG induction only, and 340 received BCG induction and maintenance therapy alone.
The primary end point of DFS was achieved, with a 32% reduction in risk of a DFS event with the addition of Imfinzi to BCG induction and maintenance. Early and sustained DFS benefit with Imfinzi was observed starting as early as four months. The median follow-up was 60.7 months.
However, the difference in DFS for Imfinzi plus BCG induction only versus BCG induction and maintenance was not statistically significant.
While overall survival (OS) data were immature, there was no detriment to OS with the addition of Imfinzi to BCG induction and maintenance therapy.
The addition of Imfinzi to BCG induction and maintenance therapy had no major impact on patient-reported quality of life, one of the secondary end points of the trial.
Regarding safety, another key secondary end point, results showed that the Imfinzi/BCG regimen was tolerable and manageable with no unexpected side effects, and there were no deaths possibly related to the study treatment. Grade 3 (severe) or 4 (life-threatening) side effects possibly related to any treatment occurred in 21% of the Imfinzi/BCG induction and maintenance arm, 15% of the Imfinzi/BCG induction arm, and 4% of the BCG induction and maintenance arm.
The most frequently reported any-grade side effects in the Imfinzi/BCG induction and maintenance and BCG-only arms included dysuria (37% versus 36%, respectively), hematuria (32% versus 30%), pollakiuria (26% versus 25%), urinary tract infection (21% versus 18%), cystitis (19% versus 19%), and pyrexia (16% versus 20%).
“Overall, these events were consistent with what we expected for Imfinzi and BCG therapy with dysuria, hematuria, and pollakiuria being the three most commonly reported in both arms,” said De Santis during the presentation.
Most patients were male, and the median age was 68. Approximately 64% of patients had papillary disease only. Patients also had high-risk tumors, defined as being either T1, high grade, carcinoma in situ, or multiple and recurrent and large.
Patients received a median of six BCG induction instillations and 14 BCG maintenance instillations, with a maximum of 15 in both arms. More than half of patients received BCG for 18 months.
“In conclusion, these results support one year of Imfinzi with BCG induction and maintenance therapy as a potential new treatment in BCG-naive, high-risk NMIBC,” De Santis said during the presentation.
According to the National Cancer Institute, NMIBC refers to bladder cancers that have not grown into the muscle layer of the bladder wall. These cancers are confined to the inner lining (urothelium) or the connective tissue just beneath it. NMIBC includes stage 0 and stage 1 disease, meaning the tumor is limited to the surface or shallow layers of the bladder and has not invaded the deeper muscular wall.
Reference
- “Durvalumab in combination with BCG for BCG-naive, high-risk, non-muscle-invasive bladder cancer” by Dr. Maria De Santis, et al., The Lancet.
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