Bladder cancer hit! Merck/Pfizer Bavencio's first-line maintenance therapy is approved by the U.S. FDA, significantly extending survival!

, July 01, 2020 /
PRNewswire/ -- Merck KGaA and partnerPfizerhave jointly announced that the U.SFood and Drug Administration (
FDA) has approved anti-PD-L1 therapy Baven (avelumab) for the maintenance of patients with local late-stage or metastatic urethra cancer (UC) who have not progressed with a first-line form of platinum-containing chemotherapyThe indications were prioritised through the Real-Time Oncology Review (RTOR) pilot project and were previously granted breakthrough drug status (BTD) by the FDAAt present, Bavencio's indications are also under regulatory review by the European Union and Japannote, Bavencio is theThe first and only immunotherapy approved by the FDAwas the first and only immunotherapy that has been shown to have significant total lifetime (OS) benefits in the first-line maintenance treatment of UC IIIclinical trial
Data from the Phase III JAVELIN Bladder 100 study show that Bavencio's combined standard care first-line maintenance therapy extended the median OS by 50% (21.4 months vs 14.3 months) compared to standard careBavencio, an immuno
tumor drug developed by Pfizer and Merck in collaboration, received accelerated approval from the U.S FDA in May 2017 to treat patients with locally advanced or metastatic urethra skin cancer (mUC) patients, specifically: (1) patients whose condition progresses during or after chemotherapy with platinum; this latest approval, based on the results of the III JAVELIN Bladder 100 study Based on the results of this validation Phase III study, the FDA has shifted Bavencio's treatment of UC indications from accelerated to fully approved "As the first immunotherapy to demonstrate a significant improvement in total survival in the first-line treatment of locally advanced or metastatic urethra skin cancer, ," said Dr Petros Grivas, lead investigator of the javelin Bladder 100 study at the The FDA's approval of Bavencio is one of the most significant advances in the treatment model for the disease in 30 years The study data showed that the median total survival of the Bavencio Plus standard care treatment group exceeded 21 months, the longest total lifetime data obtained in the advanced urethra skin cancer phase III trial, confirming that the program enhances the benefits of induced chemotherapy and prolongs the life of patients with this devastating disease The results support the potential of the Bavencio programme as a new standard of care in this study "
bladder cancer (picture source-medscape.com) JAVELIN Bladder 100 (NCT02603432) is a multicenter, multi-country, random, open-label, parallel group study conducted in patients with local late or metastatic UC who did not progress after completing first-line platinum chemotherapy, and evaluated Bavencio's joint 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 (based on RECIST v1.1 evaluation) were randomly assigned to the Bavencio-BSC treatment group or the BSC treatment group The primary endpoint is the total survival (OS) in all randomized patients and PD-L1 positive tumor patients In this study, BSC will be administered by the treatment physician at its discretion and may include antibiotics
treatment, nutritional support, metabolic disorder correction, optimal symptom control and pain management (including palliative radiation) BSC does not include any active anti-
tumor treatment, but dividend local radiation therapy is acceptable for isolated lesions results show that, in the medium-term analysis, the study reached the primary endpoint of OS: in two common major groups (all randomized patients, PD-L1-positive tumor patients), Bavencio and BSC achieved a statistically significant improvement in OS compared to BSC The specific data were: In all randomized patients, the primary OS in the Bavencio-BSC group significantly increased (21.4 months vs 14.3 months), reduced the risk of death by 31% (HR-0.69; 95% CI: 0.56-0.86; p.001), 12-month survival (71% vs 58%) and 18 months of survival (61%) In patients with PD-L1-positive tumor , Bavencio-BSC showed greater OS benefits and reduced the risk of death by up to 44% compared to BSC In this study, Bavencio's safety was consistent with that of the JAVELIN monodrug clinical development project According to the study, Bavencio is the first immunotherapy that has achieved a statistically significant statistically significant improvement in OS in clinical trials in the first-line treatment of late-stage UC For the past 30 years, chemotherapy has been the first-line standard of care for patients with late urinary skin cancer While this is an effective short-term option for many patients, most patients will eventually experience disease progression, which underscores the need for more treatment options Bavencio has the potential to change clinical practice based on the results of the ACTIVE Total Lifetime (OS) study by JAVENLIN Bladder 100 bladder cancer is the 10th 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 of bladder cancer Urinary skin cancer (UC) accounts for about 90% of bladder cancers When bladder cancer metastases, the 5-year survival rate is only 5% currently, platinum-containing chemotherapy is the first-line standard for the treatment of late-stage UC, and although the initial remission rate is high, continued and complete remission after first-line chemotherapy is not common, and most patients end up with disease progression within 9 months of starting treatment Given the poor progression of patients with advanced UC after first-line chemotherapy, additional treatment options are urgently needed to extend their life Bavencio is part of PD-(L) 1 tumor immunotherapy, a high-profile type of tumor immunotherapy designed to use the body's own immune system to fight cancer, by blocking the PD-1/PD-L1 signaling pathway to kill cancer cells, has the potential to treat a variety of types of tumors Bavencio has been shown to be involved in both adaptive and congenital immune functions in preclinical models Bavencio has been shown to release the inhibitory effect of T-cell-mediated anti-
tumors immune response in preclinical models by blocking the interaction of PD-L1 with PD-1 receptors Pfizer signed a $2.85 billion deal with Merck in November 2014 to move into PD-(L) At present, the two sides are promoting the JAVELIN clinical development project, involving more than 15 types of tumors, more than 10,000 patients In addition to gastric/gastroesophageal adenocarcinoma, these tumors types include: ovarian cancer, breast cancer
, head and neck cancer, Merkel cell carcinoma, non-small cell lung cancer, adrenal cell cancer and urinary skin cancer in the United States, Bavencio was in March 2017 The FDA accelerated approval for the treatment of pediatric and adult metastatic mMCC, which makes the drug the world's first tumor immunotherapy for mMCC, an invasive skin cancer that has a worse prognosis than the prognosis of melanoma In May 2017, Bavencio was further approved by the U.S FDA for: (1) patients with local late-stage or metastatic urethra skin cancer (mUC) who progressed during or after chemotherapy with platinum; In May 2019, Bavencio and the tyrosine kinase inhibitor Inlyta (axitinib, aschitinib) joint treatment program was approved by the FDA , the first line of treatment for patients with advanced renal cell carcinoma (RCC) (BioValleyBioon.com) original source: FDA Approves BAVENCIO as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma .