First-line immunotherapy for bladder cancer! Merck/Pfizer Bavencio Maintenance Therapy Phase III clinically significantly superior to standard care, extending patient survival!

JUNE 11, 2020 /PRNewswire/ -- Pfizer and partner Merck KGaA have announced the total survival results of the phase-by-phase analysis of the anti-PD-L1 therapy Bavencio (avelumab) first-line maintenance therapy for locally advanced or metastatic urethra skin cancer (UC) Phase III JAVELIN 100 Study (NCT02603432)The data show edinations: Bavencio's joint BSC significantly extended OS compared to Best Support Care (BSC)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 treatmentBavencio, an immuno-oncologist drug developed in collaboration with Pfizer and Merck, received accelerated FDA approval 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; The approval is based on tumor mitigation data and mitigation durationThe JAVELIN Bladder 100 study is a validation Phase III study designed to support the transition of Bavencio's treatment of UC indications from accelerated approval to full approvalIn April, Pfizer and Merck filed a supplemental biologics licensing application (sBLA) with the U.SFDA for first-line maintenance treatment in patients with locally advanced or metastatic UC, based on interim results from the studyMeanwhile, the FDA has granted Bavencio the Breakthrough Drug Qualification (BTD) for the appelate, which is currently being reviewed by the FDA under the Real-Time Oncology Review (RTOR) pilot projectBladder Cancer - (Picture source-medscape.com) JAVELIN Bladder 100 is a multicenter, multi-country, random, open-label, parallel group study conducted in local late-stage or metastatic UC patients with no progress after completing first-line platinum-containing chemotherapy, evaluating bavencio's joint optimal support care (BSC) and single BSC for first-line treatment to maintain efficacy and safetyIn 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 groupThe primary endpoint is the total survival (OS) in all randomized patients and PD-L1-positive tumor patientsIn this study, BSC will be administered by the treatment physician at its discretion and may include antibiotic 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 lesionsThe results showed that, in the mid-term analysis, the study had reached the primary endpoint of OS: in two common major groups (all randomized patients, PD-L1-positive tumor patients), Bavencio-BSC achieved a statistically significant improvement in OS compared to BSCThe 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 tumors, Bavencio-BSC showed greater OS benefits and reduced the risk of death by up to 44% compared to BSCIn this study, Bavencio's safety was consistent with that of the JAVELIN monodrug clinical development projectAccording to the study, Bavencio is the first immunotherapy that has statistically significantly improved OS in clinical trials for advanced UC treatments 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 Globally, bladder cancer is the 10th most common cancer 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 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 the Antitumor Immune Response to T-cell-mediated t-cell-mediated in preclinical models by blocking the interaction of PD-L1 with PD-1 receptors Pfizer entered pD-(L-1 in November 2014 with Merck in a $2.85 billion deal 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 tumor types include: ovarian cancer, breast cancer, head and neck cancer, Merkel cell carcinoma, non-small cell lung cancer, kidney cell cancer and urinary skin cancer In the U.S., Bavencio was accelerated by the FDA in March 2017 for the treatment of pediatric and adult metastatic mMCC, which makes the drug the world's first cancer immunotherapy for mMCC, an invasive skin cancer that is worse than melanoma prognosis 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 for first-line treatment of patients with advanced renal cell carcinoma (RCC) (BioValleyBioon.com) Sic: The bladder cancer pendulum swings towards s Bavencio