Conference Summary
Editor’s Note: At a recent academic symposium, Professor Joan Palou from the Department of Urology, Universitat Autònoma de Barcelona, Spain, presented the latest subgroup analysis from the POTOMAC study. The presentation focused on the efficacy and safety of one year of durvalumab (D) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy for BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC) patients aged ≥65 years.
01 Background: Exploring Immuno-Combination Therapy in NMIBC
POTOMAC is a randomized, open-label, global Phase III trial. Previous data demonstrated that in BCG-naïve high-risk NMIBC patients, durvalumab combined with BCG induction and 2-year maintenance significantly improved disease-free survival (DFS) compared to BCG monotherapy. The intent-to-treat (ITT) analysis reported a hazard ratio (HR) of 0.68. Given that age is a critical prognostic factor in bladder cancer, this subgroup analysis evaluated the consistency of the benefit in patients aged ≥65 years.
02 Efficacy Analysis: DFS Benefit in Patients Aged ≥65 Consistent with ITT Population
In the POTOMAC study, patients aged ≥65 years accounted for 62% of the total cohort. The analysis revealed that this elderly population experienced a sustained and robust DFS benefit from the durvalumab plus BCG regimen. Specifically, in the ≥65 years subgroup, the HR for DFS was 0.64. This result is highly consistent with the ITT population (HR 0.68), indicating a 36% reduction in the risk of disease recurrence or progression for elderly patients receiving the combination therapy.
03 Safety Profile: Well-Tolerated with No New Safety Signals
Safety is a primary concern in the management of elderly patients. Data from this subgroup analysis showed that the safety profile in patients aged ≥65 was consistent with the overall safety population: • Treatment-Related Adverse Events (AEs): The incidence was 27%. • Severe AEs: Grade 3–4 AEs occurred in 7% of patients. • Outcomes: No treatment-related deaths were reported. For patients experiencing high-grade AEs, approximately 70% achieved symptom resolution following treatment with corticosteroids. Prof. Joan Palou noted that while the combination therapy increases the incidence of toxicity compared to monotherapy, the majority of AEs are low-grade and manageable.
04 Quality of Life (QoL): No Significant Impact on Patient Functional Scores
Patient-reported outcomes (PROs) were utilized to assess the impact of the treatment on quality of life. The results indicated no major negative impact on subscale functional scores following the addition of durvalumab. Throughout the two-year maintenance period, QoL remained stable in the ≥65 years subgroup, which is a significant clinical consideration for elderly patients requiring long-term outpatient therapy.
05 Expert Conclusion and Outlook: Toward Precision Immunotherapy in NMIBC
Prof. Joan Palou concluded that the POTOMAC subgroup data further support one year of durvalumab in combination with BCG induction and maintenance as a potential new treatment standard for BCG-naïve, high-risk NMIBC patients, including those aged ≥65 years. During the discussion regarding the age cutoff, Prof. Palou clarified that while 65 was chosen for this analysis, similar benefit trends were observed when analyzing cutoffs of 70 or 75 years. Future analyses, including ctDNA and other biomarkers, are expected to further identify patients who derive the greatest benefit from this combination to optimize clinical decision-making.
