$PFE 🕒 пт, 18 сент. 2020 г., 12:20:58 MSK Pfizer, EMD Serono announce publication of JAVELIN Bladder 100 study results EMD Serono and Pfizer announced the publication of detailed results from the Phase III JAVELIN Bladder 100 study 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, or ESMO, virtual congress 2020 and describe the efficacy of Bavencio as a first-line maintenance treatment across various subgroups of patients with locally advanced or metastatic urothelial carcinoma, or UC, and highlight exploratory biomarkers as well as patient-reported outcomes. In June, the 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, Bavencio plus best supportive care, or BSC, significantly extended overall survival, or OS, compared with BSC alone in the two primary populations of all randomized patients and patients whose tumors were PD-L1+ and significantly more patients who received Bavencio as first-line maintenance were alive at one year. The clinical benefits of Bavencio were seen across a range of patient populations. 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 whose disease had not progressed on first-line platinum-containing chemotherapy. Median OS was 21.4 months vs 14.3 months, respectively. At one year, 71.3% of patients in the Bavencio arm were alive vs 58.4% of patients who received BSC alone. In the other primary population of patients with PD-L1+ tumors OS was also significantly longer with Bavencio plus BSC vs BSC alone. At one year, 79.1% of patients who received Bavencio were alive vs 60.4% in the BSC arm. All endpoints were measured from the time of randomization, after completion of four to six cycles of chemotherapy. Results of an exploratory subgroup analysis show that consistent results were observed with the JAVELIN Bladder regimen of Bavencio first-line maintenance across pre-specified subgroups, including best response to first-line chemotherapy, type of chemotherapy regimen, site of baseline metastasis, and other baseline factors.1 In particular, hazard ratios for OS based on response to first-line chemotherapy were as follows: 0.69 for complete or partial response and 0.70 for stable disease. With regard to first-line chemotherapy regimen, hazard ratios were as follows: 0.69 with gemcitabine plus cisplatin and 0.66 with gemcitabine plus carboplatin. Further detail from the subgroup analysis were presented in an on-demand mini oral session at the meeting. Additional data evaluating the association between clinical outcomes and exploratory biomarkers will be presented in the Proffered Paper 1 - GU, non prostate session on Saturday, September 19 and patient-reported outcomes are featured in an on-demand e-poster display.