A phase 1b/2, open-label study evaluating bintrafusp alfa with chemotherapy for the treatment of patients with stage IV non-small cell lung cancer (NSCLC). Orphan Drug US. Bintrafusp alfa monotherapy demonstrated efficacy, durability, and a manageable safety profile in patients with locally advanced or metastatic biliary tract cancer who have progressed or are intolerant to first-line platinum-based chemotherapy in a phase 2 study, but failed to meet the pre-determined threshold for a regulatory filing. • Overall safety/tolerability data from phase 1 studies of bintrafusp alfa and an exposure-safety analysis conducted on an integrated data set with >670 participants supported the selection of 1200 mg every 2 weeks (Q2W) as the monotherapy recommended phase 2 dose • Prior analysis of this phase 1 study (NCT02699515) expansion cohort found Not intended for US-, Canada- or UK-based media DARMSTADT, Germany, March 16, 2021 /PRNewswire/ -- Merck, a leading science and technology company, today announced topline data from the Phase II [email protected] BTC 047 study evaluating bintrafusp alfa as a monotherapy in the second-line treatment of patients with locally advanced or metastatic biliary tract cancer (BTC)… In a phase 1 study, Asian patients with pretreated esophageal SCC received bintrafusp alfa 1200 mg every 2 weeks until disease progression, unacceptable toxicity, or withdrawal. NCT04066491: Phase 2/Phase 3 Interventional Recruiting Biliary Tract Cancer (2019) Source URL: PRGN-2009 is currently under evaluation in a Phase 1/2 clinical trial as a monotherapy or in combination with bintrafusp alfa (M7824) in patients with HPV-associated cancers (clinical trial identifier: NCT04432597). Otilimab for COVID -19 therapy in Ph2. 1416. In February of 2019, Merck and GlaxoSmithKline entered into a global strategic alliance to jointly develop and commercialize bintrafusp alfa. GSK, German Merck's $4.2B bintrafusp alfa drug a bust, fails to beat king Keytruda in lung cancer. The confirmed objective response rate in the checkpoint inhibitor-naive population was 30.5% with five complete responses; eight patients had stable disease for a disease control rate of 35.6%. These results, along with those reported in the accompa-nying article from an expansion cohort of Asian patients with pretreated, PD-L1-unselected esophageal squamous cell carcinoma in a separate phase 1 study, support fur-ther clinical investigation of bintrafusp alfa in esophageal cancer. The phase 3 INTR@PID Lung 037 study evaluated bintrafusp alfa as a first-line treatment for patients with stage IV non-small cell lung cancer (NSCLC) that have high expression of PD-L1. Based on this data, a phase 1b clinical trial evaluating the stepwise addition of BN-brachyury, bintrafusp alfa, T-DM1 and entinostat in advanced breast cancer was designed. Methods In this phase I dose-expansion cohort, patients with advanced SCCHN not amenable to curative therapy that progressed/recurred after platinum therapy in the recurrent/metastatic setting, or <6 months after platinum therapy in the locally advanced setting, received bintrafusp alfa 1200 mg intravenously every 2 … The primary objective is to evaluate the recommended phase-2 dosing of eribulin and bintrafusp. Patients were randomized 1:1 to receive bintrafusp alfa 500 mg or the recommended phase 2 dose of 1200 mg every 2 weeks. Category. About M7824 (also now known as bintrafusp alfa) M7824 is an investigational bifunctional immunotherapy that is designed to combine a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein. Patients will then receive study drug (bintrafusp alfa) and eribulin with tumor assessments at 6 and 12 weeks. Bintrafusp alfa is currently under clinical investigation and not approved for any use anywhere in the world. GSK, German Merck’s $4.2B bintrafusp alfa drug a bust, fails to beat king Keytruda in lung cancer Posted on January 21, 2021 By News Team A drug that Pfizer passed over but saw a revitalized cancer R&D-focused GlaxoSmithKline jump on for $4.2 billion has come up as a dud in a key trial pitting it against U.S. Merck’s blockbuster Keytruda. Study consists of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. A phase 2, single-arm study evaluating bintrafusp alfa for the treatment of patients with advanced unresectable and/or metastatic cervical cancer who had disease progression with platinum-containing chemotherapy. - Phase II: (Arm 2) will be conducted using a Simon optimal two-stage design. That drug, originally known as M7824, now bintrafusp alfa… The NCI Center for Cancer Research's Laboratory of Tumor Immunology and Biology (LTIB) and Genitourinary Malignancies Branch (GMB) are jointly leading this Phase 2 trial (NCT04287868), which studies PDS0101 in combination with two investigational immune-modulating agents: bintrafusp alfa (M7824), a bifunctional 'trap' fusion protein targeting TGF-β and PD-L1, and … A drug that Pfizer passed over but saw a revitalized cancer R&D-focused GlaxoSmithKline jump on for $4.2 billion has come up as a dud in a key trial pitting it against U.S. Merck’s blockbuster Keytruda. Bintrafusp alfa Published 14 September 2020, ... is poor. Trial Design: This is a phase 1b/2, open-label, 4-cohort study ([NCT03840915][2]) evaluating bintrafusp alfa in combination with CT in patients with stage IV NSCLC. They also compare the safety of … Bintrafusp alfa will be administered as a "flat" dose of 1,200 mg independent of body weight. Abstract Title: Phase II evaluation of the triple combination of PDS0101, M9241, and bintrafusp alfa in patients with HPV 16 positive malignancies. – M7824 (intravenous 1200 mg fixed dose) will be delivered every 2 weeks – Patients will receive treatment in cycles consisting of 4 weeks. • 8 assets advanced into Phase 1, 3 into Phase 2, 4 into Phase 3 (Zejula 1L OC, dostarlimab EC, bintrafusp alfa BTC, otilimab RA), plus 3 vaccines progressed into Phase 1/2, 3 approvals (Dovato, Dectova, Nucala pre-filled syringe) and 11 terminations • Doubled the number of clinical oncology assets in the pipeline from 8 to 17 from a phase 1 expansion cohort. – A maximum of 75 subjects will be enrolled in this trial. Asian cohort 2. ICOS HNSCC is a Phase 2/3 study with registrational potential 2. Bintrafusp alfa, a first-in-class bifunctional fusion protein composed of the extracellular domain of the TGF-βRII receptor (TGF-β "trap") fused to a human IgG1-blocking PD-L1, showed a manageable safety profile and clinical activity in phase I studies in patients with heavily pretreated advanced solid tumors. Phase III Clinical Trials . Methods: NCT02699515 was a phase I, open-label, dose-escalation study of bintrafusp alfa (3, 10, and 20 mg/kg every 2 weeks) in Asian patients with advanced solid tumors, including a hepatocellular carcinoma (HCC) safety-assessment cohort. Results As of August 24, 2018, 35 patients received bintrafusp alfa for a median of 1.8 (range, 0.5-20.7) months. The abstract summarizing interim data from the National Cancer Institute (NCI)-led phase 2 trial has been accepted for oral presentation at the 2021 ASCO Annual Meeting taking place June 4-8. Bintrafusp alfa is currently under clinical investigation and not approved for any use anywhere in the world. Study consists of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. US developmental status. The confirmed objective response rate in the checkpoint inhibitor-naive population was 30.5% with five complete responses; eight patients had stable disease for a disease control rate of 35.6%. tolerability of bintrafusp alfa in 23 Asian patients with heavily pretreated metastatic or locally advanced solid tumors (includ-ing HCC) unselected for tumor PD-L1 expression. Merck is not throwing in the towel completely for this target, as an ongoing phase 2/3 study of bintrafusp alfa with chemo as a first-line treatment for BTC “is assessing a … Abstract Title: Phase II evaluation of the triple combination of PDS0101, M9241, and bintrafusp alfa in patients with HPV 16 positive malignancies. In the 3 + 3 dose-escalation component of phase I study (NCT02517398), eligible patients with advanced solid tumors received Bintrafusp alfa once every 2 weeks until confirmed progression, unacceptable toxicity or trial withdrawal. were randomized to receive bintrafusp alfa 500 mg or the recommended phase 2 dosage of 1200 mg (n=40 each) every 2 weeks (Q2W) until disease progression, unacceptable toxicity, or trial withdrawal – Patients who achieved stable disease (SD), complete response (CR), or partial response Background: Bintrafusp alfa (M7824) is a first-in-class bifunctional fusion protein composed of the extracellular domain of the TGF-βRII receptor (a TGF-β “trap”) fused to a human IgG1 mAb blocking PD-L1. As of October 15, 2019, a total of 40 patients received bintrafusp alfa at the recommended phase 2 dose of 1200 mg Q2W for a median of 17 (range, 2-136) weeks, with a median follow-up of 128 weeks; 18 patients were still alive, 3 patients had an ongoing response, and 1 patient remained on treatment. About this study. Merck, a leading science and technology company, today announced an update on the Phase III INTR@PID Lung 037 study and the extensive INTR@PID clinical trial program for the potential first-in-class investigational bifunctional immunotherapy bintrafusp alfa, in difficult-to-treat cancers, including biliary tract cancer (BTC) and cervical cancer.
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