700 pts were randomized (350 per arm); 358 (51.1%) had PD-L1+ tumors. With extended follow-up (median, ≥38 months in both arms for all pts; data cutoff, June 4, 2021), OS remained significantly longer in the avelumab+BSC vs BSC alone arm in all randomized pts and in pts with PD-L1+ tumors (Table).

700 pts were randomized (350 per arm); 358 (51.1%) had PD-L1+ tumors. With extended follow-up (median, =38 months in both arms for all pts; data cutoff, June 4, 2021), OS remained significantly longer in the avelumab + BSC vs BSC alone arm in all randomized pts and in pts with PD-L1+ tumors (Table)....Long-term follow-up from the JAVELIN Bladder 100 trial continues to show prolonged OS with avelumab + BSC vs BSC alone.

An OS benefit was seen for avelumab 1L maintenance + BSC vs BSC alone across subgroups of interest. Results are consistent with previously reported findings, further supporting avelumab 1L maintenance as a standard of care for pts with advanced UC that has not progressed with 1L platinum-containing chemotherapy.

Among all 700 patients who underwent randomization, the addition of maintenance avelumab to best supportive care significantly prolonged overall survival as compared with best supportive care alone (control). Overall survival at 1 year was 71.3% in the avelumab group and 58.4% in the control group (median overall survival, 21.4 months vs. 14.3 months; hazard ratio for death, 0.69; 95% confidence interval [CI], 0.56 to 0.86; P=0.001)....Maintenance avelumab plus best supportive care significantly prolonged overall survival, as compared with best supportive care alone, among patients with urothelial cancer who had disease that had not progressed with first-line chemotherapy.

Avelumab + BSC significantly prolonged OS vs BSC alone in all randomized patients...Avelumab + BSC also significantly prolonged OS vs BSC alone in patients with PD-L1+ tumors....JAVELIN Bladder 100 met its primary objective, demonstrating significantly prolonged OS with 1L maintenance avelumab + BSC vs BSC alone in advanced UC in all randomized patients and patients with PD-L1+ tumors.

...today announced completion of the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for BAVENCIO® (avelumab)* for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC)....A statistically significant improvement was demonstrated in both co-primary populations: all randomized patients and patients with PD-L1–positive tumors.

Have immunohistochemical expression of PD-L1 ≥ 5% on tumor cells in archived tumor biopsies.

198 patients were screened, with 71 (35.9%) whose PD-L1 expression was ≥5% enrolled in the study….The median OS was 10.0 months (95% CI, 5.5-14.5) and 43% of patients were alive at one year. A complete response was achieved in 8.5% of cases and 15.5% had a partial response....This ARIES trial confirmed the activity and safety of avelumab for treating mUC, adding a new therapy option to the armamentarium of checkpoint inhibitors already approved for platinum-ineligible, locally advanced/mUC.

Eligible patients with unresectable locally advanced or metastatic UC...Japanese patients (n=73) were randomized to receive Ave + BSC (n=36) or BSC alone (n=37); 52.8% vs 62.2% had PD-L1+ tumors, respectively. Median OS (95% CI) was 24.7 months (18.2-not estimable [NE]) with Ave + BSC vs 18.7 months (12.8-33.0) with BSC alone (HR, 0.81 [95% CI; 0.409-1.585]) in all randomized patients...

249 patients received avelumab; efficacy was assessed in 242 postplatinum patients....The confirmed ORR was 16.5% (95% CI 12.1% to 21.8%; complete response in 4.1% and partial response in 12.4%)....For PD-L1 expression, 214 patients (88.4%) were evaluable, of whom 84 (39.3%) had PD-L1+ tumors and 130 (60.7%) had PD-L1− tumors...(Additional file 4).

There have been higher overall response rates in UC patients with tumors with high vs. low PD-L1 expression among studies. The more significant differences were noted with avelumab (54% vs. 4%)...