First line immunotherapy for bladder cancer! Merck / Pfizer bavencio combined with best support nursing phase III clinical significantly improved overall survival (OS)!

January 7, 2020 / Biovalley BIOON / -- Pfizer, a US pharmaceutical giant, and Merck KGaA, a partner, recently jointly announced that the evaluation of bavencio (avelumab), a PD-L1 tumor immunotherapy, for the treatment of urothelial cancer (UC) stage III javenlin blade 100 (nct02603432) has reached the main end point of total survival (OS) in the mid-term analysis The study is a confirmatory study designed to support the transition of bavencio indications for UC from accelerated to full approval This is a multicenter, multinational, randomized, open label, parallel group study It was conducted in patients with locally advanced or metastatic UC who did not progress after first-line platinum chemotherapy The efficacy and safety of bavencio combined with best support care (BSC) and single BSC for first-line maintenance were evaluated In the study, 700 patients who did not progress after induction chemotherapy (according to RECIST v1.1 evaluation) were randomly assigned to bavencio + BSC treatment group or BSC treatment group The primary end point was OS in the common major population of all patients and PD-L1 positive tumor patients The results showed that the OS of bavencio + BSC group was significantly improved compared with BSC group in two common main groups (all randomized patients, PD-L1 positive tumor patients) The safety of bavencio in this study is consistent with that of Javelin single drug clinical development project The results of the study will be presented to an upcoming medical conference and shared with the FDA and other regulators Dr Chris boshoff, chief development officer of oncology, Pfizer's global product development department, said: "bavencio is the first immunotherapy in clinical trials to achieve a statistically significant improvement in the overall survival of advanced urothelial cancer These latest positive data from the javelin clinical development project provide a great deal of evidence for bavencio's treatment of urogenital cancer, and we look forward to discussing these results with regulators " Urothelial carcinoma (UC) accounts for 90% of bladder cancer When bladder cancer metastasized, the 5-year survival rate was only 5% Combined chemotherapy is the first-line standard for the treatment of advanced diseases Although the initial remission rate is very high, continuous and complete remission after first-line chemotherapy is not common Most patients will eventually develop disease progress within 9 months after the start of treatment Bavencio belongs to PD - (L) 1 tumor immunotherapy, which is a kind of tumor immunotherapy with great attention at present It aims to use the immune system of human body to resist cancer, and block the PD-1 / PD-L1 signal pathway to make cancer cells die It has the potential to treat various types of tumor Bavencio has been shown to be involved in both adaptive and innate immune functions in preclinical models Bavencio, by blocking the interaction between PD-L1 and PD-1 receptor, has been shown to release inhibition of T cell-mediated anti-tumor immune response in preclinical models Pfizer and Merck signed an agreement of up to US $2.85 billion in November 2014 to enter the PD - (L) 1 field At present, the two sides are promoting the javelin clinical development project, which involves more than 15 different types of tumors and more than 10000 patients In addition to gastric / gastroesophageal junction adenocarcinoma, these tumor types include ovarian cancer, breast cancer, head and neck cancer, Merkel cell cancer, non-small cell lung cancer, renal cell cancer and urothelial cancer In the United States, bavencio was approved by FDA in March 2017 for the treatment of pediatric and adult metastatic Merkel cell carcinoma (MCMC) aged 12 and over This approval makes bavencio the first tumor immunotherapy in the world to treat MCMC, which is an invasive skin cancer with worse prognosis than melanoma In May 2017, bavencio was approved by the US FDA for: (1) patients with locally advanced or metastatic urothelial carcinoma (MUC) during or after chemotherapy with platinum; (2) patients with locally advanced or metastatic urothelial carcinoma (MUC) who underwent preoperative (neoadjuvant) or postoperative (adjuvant) chemotherapy with platinum for 12 months In May 2019, the combination of bavencio and tyrosine kinase inhibitor inlyta (axitinib, acitinib) was approved by the FDA, and the first-line treatment for advanced renal cell carcinoma (RCC) patients Source of the original text: bakencio designificational advanced overall military in patients with local advanced or metallic regional automotive