Express . . . It is expected to change the standard treatment model, with Merck/Pfizer PD-L1 inhibitors approved for first-line maintenance treatment for urinary skin cancer.

Yesterday, Merck KGaA and Pfizer jointly announced that the US FDA has approved the application for SBLA of PD-L1 antibody bavencio (avelumab) for the first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma (UC) patients who have not progressed after platinum containing chemotherapy.the press release states that this is the first-line immunotherapy to provide significant overall survival improvement in this patient population in phase 3 clinical trials.bladder cancer is the 10th most common cancer in the world. In 2018, more than 500000 new cases of bladder cancer were diagnosed, and about 200000 people died of bladder cancer worldwide.urothelial carcinoma (UC) accounts for about 90% of all bladder cancers.it becomes more difficult to treat as the disease progresses and spreads through all layers of the bladder wall.based on the high initial remission rate, platinum based chemotherapy is currently the first-line standard treatment for advanced patients.however, most patients eventually develop disease within 9 months after the start of treatment, and only 5% of patients diagnosed with metastatic disease have a survival time of more than 5 years.bavencio is a humanized monoclonal antibody against PD-L1.bavencio has been shown to stimulate adaptive and innate immune function in preclinical models.by blocking the interaction between PD-L1 and PD-1 receptor, bavencio has been shown to relieve inhibition of T-cell-mediated anti-tumor immune response in preclinical models. In November 2014, Merck and Pfizer announced a strategic alliance to jointly develop and commercialize bavencio.this approval was based on the results of the phase 3 clinical trial javelin bladder 100 study, which showed that bavencio, as the first-line maintenance therapy combined with BSC, significantly improved the median overall survival (OS) by 7.1 months: 21.4 months (95% CI: 18.9 to 26.1) vs. 14.3 months (95% CI: 12.9 to 17.9) compared with the best support treatment (BSC).the overall risk of death was reduced by 31% (HR = 0.69; 95% CI: 0.56-0.86; P = 0.001).Dr. Petros Grivas, one of the main researchers in the javelin bladder 100 trial, said: "as the first immunotherapy to show statistically significant improvement in overall survival in the first-line treatment of locally advanced or metastatic urothelial carcinoma, the FDA approval of avelumab is one of the most significant advances in the treatment model in this situation in 30 years.javelin bladder 100 regimen with avelumab as the first-line conversion maintenance treatment may become a new standard treatment."many patients newly diagnosed with advanced urothelial cancer benefit from initial therapy, but we still need treatments that can help patients extend their lives," says Andrea, CEO of bladder cancer advocacy network Ms. Maddox Smith said: "we wholeheartedly support the development of promising innovative treatments like bavencio that can bring hope to patients and their loved ones."with bavencio's approval, we have the opportunity to fundamentally change the standard of first-line treatment for advanced bladder cancer.our focus now is to ensure that this novel treatment, which may change the patient's life, is quickly integrated into clinical practice. "said Mr. Rehan VERJEE, global head of biopharmaceutical business of Merck, Germany. note: This article aims to introduce the progress of medical and health research, not to recommend treatment options. if you need guidance on treatment plan, please go to a regular hospital. References: [1] FDA approved bavencio as first line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma. Retrieved 2020-07-01, from