Phase III JAVELIN Bladder 100 study of Bavencio in urothelial carcinoma published in NEJM.- EMD Serono + Pfizer

EMD Serono and Pfizer announced the publication of detailed results from the Phase III JAVELIN Bladder 100 study of Bavencio (avelumab) online ahead of print in The New England Journal of Medicine. These results were published simultaneously with additional analyses being presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 and describe the efficacy of avelumab as a first-line maintenance treatment across various subgroups of patients with locally advanced or metastatic urothelial carcinoma (UC) and highlight exploratory biomarkers as well as patient-reported outcomes. In June, FDA approved Bavencio for the maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy based on the JAVELIN Bladder 100 results. In the JAVELIN Bladder 100 study, OS was significantly longer with Bavencio plus BSC compared to BSC alone in the primary population of all randomized patients (n=700) whose disease had not progressed on first-line platinum-containing chemotherapy: Median OS was 21.4 months (95% CI, 18.9 to 26.1) vs 14.3 months (95% CI, 12.9 to 17.9), respectively (HR 0.69; 95% CI, 0.56 to 0.86; P<0.001). at one year, 71.3% of patients (95% ci, 66.0% to 76.0%) in the bavencio arm were alive vs 58.4% (95% ci, 52.7% to 63.7%) of patients who received bsc alone. in the other primary population of patients with pd-l1+ tumors (n="358):" os was also significantly longer with bavencio plus bsc vs bsc alone (hr 0.56; 95% ci, 0.40 to 0.79; p><0.001). at one year, 79.1% (95% ci, 72.1% to 84.5%) of patients who received bavencio were alive vs 60.4% (95% ci, 52.0% to 67.7%) in the bsc arm. see: “avelumab maintenance therapy for advanced or metastatic urothelial carcinoma" thomas powles et al. nejm september 18, 2020 doi: 10.1056 nejmoa2002788.>