The first successful first-line maintenance treatment of bladder cancer with PD-L1 mAb

On January 6, Pfizer / Merck xuelanuo announced that the phase III javelin bladder 100 study reached the main end point of improving OS in the scheduled mid-term analysis In the javelin bladder 100 study, 700 patients with locally advanced or metastatic urothelial carcinoma who had not progressed after induction chemotherapy were randomly divided into bavencio (avelumab) and best support treatment (BSC) as the first-line maintenance treatment, or only BSC The results showed that the survival time of bavencio + BSC group was significantly longer than that of patients receiving only BSC, and this statistical significant difference was found in all patients and PD-L1 positive subgroup On May 9, 2017, the FDA accelerated the approval of bavencio for the treatment of locally advanced or metastatic urothelial carcinoma with disease progression after platinum chemotherapy or disease deterioration within 12 months after preoperative / postoperative platinum chemotherapy The results of the javelin bladder 100 study will be used as conclusive evidence by Pfizer / Merck to seek full FDA approval for the indication.