Bladder cancer immunotherapy! Merck/Pfizer anti-PD-L1 therapy Bavencio first-line maintenance therapy indications in the United States, Japan and Europe into the review!

, June 23, 2020 /PRNewswireBiovalleyBIOON/--Pfizerand partner Merck KGaA have jointly announced that the European Medicines Agency (EMA) has accepted a Class II change application for the anti-PD-L1 therapy Bacioven (avelumab): first-line maintenance treatment for patients with locally advanced or metastatic urethra skin cancer (UC)The EMA has now initiated a review processearlier this year, the U.SFood and Drug Administration (
)The FDA) has processed Bavencio's application for a supplemental biologics license (sBLA) for the indications described above, which is being prioritized through the real-timeOncologyReview (RTOR) pilot projectPreviously, theFDAalso granted Bavencio a breakthrough drug (BTD) for the treatment of the indicationsIn addition, Japan's Ministry of Health, Labour (MHLW) has also accepted applications for new drugs (sNDA) for Bavencio's indications application based on the results of the III JAVELIN Bladder 100 Study (NCT02603432) The data showed that the study reached the primary endpoint: the total survival (OS) of the Bavencio combined BSC treatment group showed a statistically significant improvement compared to the Best Supportive Care (BSC) treatment group The data was published at the ASCO 2020 Virtual Science conference It is worth mentioning that the JAVELIN Bladder 100 study marks the first time in phase III trials that an immunotherapy has shown Better OS data than standard care in terms of localized late or metastatic UC in first-line treatment Bavencio, an immuno-oncologisdrug developed by Pfizer and Merck in partnership, was awarded the U.S in May 2017 FDA accelerated approval for the treatment of patients with locallate or metastatic urinary tract skin cancer (mUC), as follows: (1) patients whose condition progresses during or after chemotherapy with platinum; The approval is based on tumor mitigation data and mitigation duration JAVELIN Bladder 100 Study is a validation Phase III study designed to support the transition of Bavencio's treatment of UC indications from accelerated to full yupable bladder cancer (picture source - medscape.com) JAVELIN Bladder 100 is a multi-center, multi-country, random, open-label, parallel group study conducted in local late or metastatic UC patients with no progress after completion of first-line platinum-containing chemotherapy, evaluating the efficacy and safety of Bavencio Combined Best Support Care (BSC) and single 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 the study, BSC will be administered by a 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% Combined chemotherapy is currently the first-line standard for the treatment of advanced diseases, 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 bladder cancer after first-line chemotherapy, additional treatment options are urgently needed to improve their overall survival Bavencio is a 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 entered pD-(L1 by signing a $2.85 billion deal with Merck in November 2014 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: European Medicines Agency app for BAvenCIO ® (avelumab) for First-Line Maintenance Treatment of Local advanced or Metastatic Urothelial Carcinoma .