First-line immunotherapy for bladder cancer! Merck/Pfizer Bavencio is eligible by the FDA for breakthrough drug review in real time!

April 10, 2020 /
PRNewswire
BIOON/ -- Pfizer
and partner Merck KGaA have jointly announced that they have filed a supplementary biologics license application (BLA) with the U.S Food and Drug Administration (FDA) to use the anti-PD-L1 therapy Bavencio for first-line therapy for patients with localized advanced or metastatic urinary tract cancer (UC) The FDA has granted Bavencio a breakthrough drug qualification (BTD) for the indications, and the BLA is being reviewed by the FDA based on the real-time Oncology Review (RTOR) pilot project May 2017, Bavencio was awarded the U.S FDA accelerated approval to treat patients with advanced or metastatic urinary tract cancer (mUC) in the following areas, as follows: (1) patients with progress during or after chemotherapy, and (2) patients who receive progress before or after surgery (new assisted treatment) or after surgery (assisted treatment) who receive platinum-containing chemotherapy for 12 months This approval is based on tumor mitigation data and mitigation duration the BLA and BTD are based on the positive results of the mid-term analysis of the PHASE III JAVENLIN Bladder 100 study (NCT02603432) The study is a validation Phase III study designed to support the transition from accelerated approval to full approval for Bavencio treatment UC indications It is worth noting that this study marks the first time that an immunotherapy has been shown in Phase III trials to be superior to standard care in the treatment of topical advanced or metastatic urinary disease JAVENLIN Bladder 100 is a multi-center, multi-country, random, open label, parallel group study conducted in localized advanced or metastatic UC patients whose condition did not progress after first-line platinum chemotherapy, and evaluated the efficacy and safety of Bavencio Combined Best SupportEd Care (BSC) and single-use BSC for first-line maintenance therapy In the study, a total of 700 patients who did not progress after induced chemotherapy (according to RECIST v1.1) were randomly assigned to the Bavencio-BSC treatment group or BSC treatment group The primary endpoint is total survival (OS) in the common primary group of patients with all patients and PD-L1-positive tumor
results showed that in the mid-term analysis, the study had reached the main end point of OS: in 2 common major groups (all randomized patients, PD-L1-positive tumor patients), the Bavencio-BSC group OS showed a statistically significant improvement compared to the BSC group In the study, Bavencio's safety was consistent with that of JAVELIN single-drug clinical development projects The results of the study will be presented to the of the upcoming Medical Conference and will be shared with regulators "Bavencio is the first immunotherapy to achieve a statistically significant statistically significant improvement in overall survival in the of clinical trials for advanced urinary skin cancer," said Dr Chri Bohoff, Chief Oncology Officer, Pfizer Global Product Development Real-time of oncology and breakthrough drug eligibility reflect the potential impact of Bavencio in this patient environment and provide an opportunity to bring this treatment option to the patient as quickly as possible Dr Petro Griva, one of the lead investigators in the JAVENLIN Bladder 100 study, said: "For the past 30 years, chemotherapy has been a first-line standard of care for patients with advanced urinary skin cancer While this is an effective short-term option for many patients, most will eventually experience progression of the disease, which underscores the need for more treatment options Based on the positive total lifetime (OS) results of the JAVENLIN Bladder 100 study, I believe Bavencio has the potential to change clinical practice "
, bladder cancer is the tenth most common cancer worldwide In 2018, more than half a million new cases of bladder cancer were confirmed, and about 200,000 people worldwide died from bladder cancer Urinary skin cancer (UC) accounts for about 90% of bladder cancer When bladder cancer is metastasized, the five-year survival rate is only 5% Combined chemotherapy is currently the first-line standard for the treatment of advanced diseases, and although the initial remission rate is high, it is not common for patients to experience progression after first-line chemotherapy, and most patients will eventually develop within 9 months of starting treatment Given the poor progression of patients with advanced bladder cancer after first-line chemotherapy, there is an urgent need for additional treatment options to improve overall survival Bavencio belongs to PD-(L)1 tumor immunotherapy, a high-profile type of tumor immunotherapy designed to use the body's own immune system to fight cancer, and to kill cancer cells by blocking the PD-1/PD-L1 signaling pathway, with the potential to treat multiple types of tumors Bavencio has been shown in preclinical models to be involved in both adaptive and congenital immune function By blocking the interaction between PD-L1 and The PD-1 receptor, Bavencio has been shown to release anti-
tumor immune response in preclinical models Pfizer signed a $2.85 billion deal with Merck in November 2014 to enter the PD-(L)1 sector Currently, the two sides are promoting the JAVELIN clinical development project, which involves more than 15 different types of tumors, more than 10,000 patients In addition to gastric/gastroesophageal cancer, these types of cancer include: ovarian cancer, breast cancer , head and neck cancer, Merkel cell carcinoma, non-small cell lung cancer, renal cell carcinoma and urethra carcinoma in the United States, Bavencio was in March 2017 The FDA accelerated approval for the treatment of pediatric and adult metastatic meltomy cell carcinoma (mMCC), making it the first tumor immunotherapy in the world to treat mMCC, an invasive skin cancer that is worse than the prognosis melanoma In May 2017, Bavencio was further approved by the U.S FDA for: (1) patients with localized advanced or metastatic urinary tract cancer (mUC) during or after chemotherapy; In May 2019, Bavencio's joint treatment with tyrosine kinase inhibitor Inlyta (axitinib, axiti) was approved by the FDA to treat patients with advanced renal cell carcinoma (RCC) on the first stage (BioValleyBioon.com) Original Source: EMD Serono and Pfizer Receive US FDA
Form TheRapy Deignation and Submit app lication for BAVENCIO® for firt-Line Maintenance Care of Locally Advanced or Metatatic Urotheal Carcinoma