© 2025 MJH Life Sciences™ and CURE - Oncology & Cancer News for Patients & Caregivers. All rights reserved.
Patients with advanced urothelial carcinoma had prolonged survival with Bavencio and BSC treatment, regardless of diabetes mellitus status.
Among patients with advanced urothelial carcinoma, first-line maintenance treatment with Bavencio (avelumab) plus best supportive care (BSC) prolonged overall survival (OS) and progression-free survival (PFS) versus BSC, regardless of diabetes mellitus status, according to exploratory analyses from the phase 3 JAVELIN Bladder 100 trial.
These data were shared at the 2025 Genitourinary Cancers Symposium, which showed that in the subgroup of patients with diabetes mellitus, those who received Bavencio plus BSC (55 patients) achieved a median OS of 20.8 months versus 14.5 months with BSC alone. At two years, OS rates were 44.5% and 34.1%, respectively. At three years, OS rates were 33.1% and 20.3%, respectively. Among patients without diabetes, median OS was 24.7 months with Bavencio plus BSC versus 15.8 months with BSC alone. The two-year OS rates were 50.7% and 39.4%, respectively. The three-year OS rates were 36.6% and 31.9%.
Similarly, PFS was prolonged in both patient subgroups. In those with diabetes, median PFS was 5.6 months with Bavencio plus BSC versus 2 months with BSC alone. At two years, PFS rates were 18.5% and 9.2%, respectively. At three years, PFS rates were 13.5% and 5.5%, respectively. In patients without diabetes, median PFS was 5.4 months with Bavencio plus BSC versus 2.1 months with BSC alone. The 2-year PFS rates were 24.3% and 6.5%, respectively. The 3-year PFS rates were 16.3% and 5.3%, respectively.
Best supportive care (BSC): the optimal level of care provided to a patient.
Overall survival (OS): the average length of time that patients are alive after starting treatment or being diagnosed.
Progression-free survival (PFS): the amount of time a patient lives with a disease without it worsening.
Lipase: an enzyme that helps digest fats in food.
Amylase: an enzyme that breaks down carbohydrates, like starches, into simple sugars.
“Overall, these results show that Bavencio frontline maintenance is associated with long-term efficacy benefits and consistent safety in patients with advanced urothelial carcinoma with or without diabetes mellitus who are progression free after first-line platinum-based chemotherapy,” explained lead study author Dr. Shilpa Gupta, director of Genitourinary Medical Oncology at the Cleveland Clinic Taussig Cancer Institute in Ohio.
The trial included patients with unresectable locally advanced or metastatic urothelial carcinoma who remained progression free following 4 to 6 cycles of first-line platinum-based chemotherapy. Patients were assigned to receive frontline maintenance with Bavencio plus BSC or BSC alone. The exploratory analysis assessed long-term efficacy and safety outcomes in subgroups of patients with or without documented diabetes mellitus at randomization.
At a data cutoff of June 4, 2021, with at least two years of follow-up, median OS was significantly prolonged in the Bavencio plus BSC cohort compared with BSC alone, at 23.8 months versus 15.0 months, respectively.Similarly, median PFS was 5.5 months in the Bavencio arm versus 2.1 months in the BSC alone arm, demonstrating the clinical benefit of Bavencio maintenance therapy in this setting.
Results also demonstrated the long-term safety of Bavencio maintenance therapy, with health-related quality of life preserved throughout treatment. These results contributed to the inclusion of Bavencio frontline maintenance in updated international guidelines as a recommended treatment option for patients with advanced urothelial carcinoma.
Additionally, the study explored the effects of diabetes mellitus, a known risk factor for bladder cancer that is more prevalent in older adults. Previous research has suggested that diabetes may be associated with reduced efficacy of immunotherapy in some cancers; however, data in urothelial carcinoma remain limited. As a result, this post hoc exploratory analysis from JAVELIN Bladder 100 was conducted to assess outcomes in subgroups of patients with or without diabetes mellitus at randomization.
Baseline demographics and disease characteristics were assessed by diabetes mellitus status, and median follow-up was at least 38 months in both treatment arms.
The median age among patients with diabetes mellitus was 70 years (range, 51-86) in the Bavencio plus BSC arm and 72 years (range, 57-89) in the BSC alone arm. Among patients without diabetes mellitus, the median age was 68 years (range, 37-90) with Bavencio and 69 years (range, 32-85) with BSC alone. Most patients were male in both diabetes subgroups (87.3% and 91.5% with Bavencio and BSC alone in the diabetes cohort, respectively, and 73.9% and 75.9% in the non-diabetes cohort).
Most patients were enrolled from Europe. Smaller proportions were from North America, Asia, and Australasia.
In the diabetes subgroup, 52.7% of patients in the Bavencio arm and 32.2% in the BSC arm were PD-L1 positive. Among patients without diabetes, 54.2% and 51.5% were PD-L1 positive in the Bavencio and BSC arms, respectively.
In the Bavencio plus BSC arm, grade 3 or greater treatment-related side effects (TRSEs) were reported in 24.1% (13 patients) of patients with diabetes and 18.6% (54 patients) of those without diabetes. The most common grade 3 of higher TRSEs were increased lipase, amylase and anemia. In the BSC alone arm, 1.7% of patients in both subgroups experienced any-grade TRSEs.
Serious side effects (SEs) occurred in 37.0% of patients with diabetes and 29.3% of those without diabetes receiving Bavencio. Among these, 9.3% and 10.3%, respectively, were classified as serious TRSEs. In the BSC alone group, 23.7% of patients with diabetes and 20.3% of those without diabetes experienced serious SEs, and no serious TRSEs were reported.
Bavencio discontinuation due to TRSEs occurred in 11.1% of patients with diabetes and 14.8% of those without diabetes, with 9.3% and 12.1% of cases directly attributed to TRSEs. TRSEs leading to death were rare, occurring in 1.9% of patients with diabetes and 2.1% of those without diabetes in the Bavencio group.
Immune-related SEs (irSEs) were observed in 31.5% (17 patients) of patients with diabetes and 32.4% (94 patients) of those without diabetes treated with Bavencio, compared with 3.4% and 1.4% of patients in the BSC alone group.
The most commonly reported TRSEs of any grade in the Bavencio plus BSC arm included pruritus (11.1% versus 15.5% in the diabetes and non-diabetes cohorts, respectively), hypothyroidism (7.4% versus 11.7%), fatigue (5.6% versus 11.7%), and asthenia (9.3% versus 10.7%). Gastrointestinal-related TRSEs, including diarrhea (7.4% versus 11.0%) and nausea (9.3% versus 6.9%), were also frequently observed.
References:
For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.
Related Content:
