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    Home > Medical News > Medical Research Articles > Roche ga101 phase III cll11 defeats the blockbuster drug meropene

    Roche ga101 phase III cll11 defeats the blockbuster drug meropene

    • Last Update: 2020-04-03
    • Source: Internet
    • Author: User
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    July 25, 2013 - Roche released positive data on the phase III cll11 study of experimental monoclonal antibody ga101 (obinutuzumab) on July 24 In an established mid-term analysis, an independent data monitoring committee analysis found that the study reached the primary end point: in patients with previously untreated chronic lymphoblastic leukemia (CLL), compared with rituxan plus chemotherapy drug chlorambucil, ga101 + NBR significantly prolonged disease progression free survival (PFS) No new safety signals were found in the study, and adverse events were consistent with data from the first phase of the study earlier this year Cll11 research is currently being carried out by Genentech in cooperation with the German leukemia research group (gcllsg), and the final data will be submitted to the 55th annual meeting of the American Society of Hematology in December 2013 Ga101 is the first glycosylated type II anti-CD20 monoclonal antibody, which means that specific sugar molecules in ga101 can be modified to change their interaction with human immune cells This modification creates a unique antibody designed as an immunotherapy that uses the patient's own immune system to help attack cancer cells In addition, the combination of ga101 and CD20 can directly induce cell death Ga101 aims to enhance the antibody dependent cellular toxicity (ADCC) and direct cell death induction Ga101 was developed by gyroma AG, a wholly-owned subsidiary of Roche, using its proprietary antibody modification technology, glycomab technology Both the drug and rituxan (generic name: rituximab, rituximab) selectively target CD20 protein on B cells At present, rituximab has been recommended by Japan and overseas to be included in the treatment guide of non Hodgkin's lymphoma Rituxan, a chimeric mouse / human monoclonal antibody, is the world's first monoclonal antibody approved for clinical treatment of non Hodgkin's lymphoma (NHL) Its European patent will expire at the end of 2013 If the research and development of ga101 is successful, it will reduce the impact of biosimilars on rituximab Based on cll11 test data, Roche has submitted ga101 marketing application to FDA and EMA respectively in April this year Previously, FDA has granted ga101 breakthrough therapy design and priority review to speed up drug development and approval CLL is one of the most common blood cancers, with nearly 5000 deaths expected in the United States in 2013 Patients in the cll11 study included older patients with CLL who had not previously been treated and who were generally unable to tolerate the active treatment options available Roche's new leukaemia drug superior to rituxan in study Basel, 24 July 2013 Roche's obinutuzumab (GA101) delayed disease progression longer than MabThera/Rituxan in people with one of the most common forms of blood cancer Phase III CLL11 study showed GA101 plus chlorambucil, a chemotherapy, was superior to MabThera/Rituxan plus chlorambucil in helping people with previously untreated chronic lymphocytic leukemia live longer without their disease worsening Final data from the CLL11 study will be submitted to the American Society of Hematology’s 55th Annual Meeting in December 2013 Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the phase III CLL11 study At a pre-planned interim analysis, an independent data monitoring committee determined that the study met its primary endpoint showing that GA101 plus chlorambucil helped people live significantly longer without their disease worsening (progression-free survival; PFS) compared to MabThera/Rituxan plus chlorambucil The CLL11 study is being conducted in cooperation with the German CLL Study Group (GCLLSG) These final data were reached well ahead of the target completion date in 2014 as a result of the magnitude of difference seen between the two study arms No new safety signals for GA101 or MabThera/Rituxan were identified in this analysis, and adverse events were similar to those observed in the first stage of the study which was previously reported earlier this year “The positive final results from the CLL11 study show the promise that GA101 could hold for people with CLL,” said Hal Barron, M.D., Roche’s Chief Medical Officer and Head, Global Product Development "It is important to explore the potential of this medicine in other types of blood cancer, and our broad development program includes studies in aggressive and indolent lymphoma that compare GA101with MabThera/Rituxan." GA101 is the first type II anti-CD20 medicine that is glycoengineered, which means specific sugar molecules in GA101 were modified to change its interaction with the body’s immune cells This modification creates a unique antibody that is designed to act as an immunotherapy, engaging the patient’s own immune system to help attack the cancerous cells; in addition, GA101 binds to CD20 with the aim of inducing direct cell death These data will be submitted for consideration to the 55th Annual Meeting of the American Society of Hematology (ASH) in New Orleans, which is taking place December 7-10, 2013 Based on an earlier analysis (stage 1) of the CLL11 study, marketing applications for GA101 were submitted to regulatory authorities including the U.S Food and Drug Administration (FDA) and European Medicines Agency (EMA) in April, 2013 Due to the significance of the positive trial results and the serious and life threatening nature of CLL, the FDA granted the GA101 application both Breakthrough Therapy Designation and Priority Review About obinutuzumab (GA101) GA101 is the first investigational type II, glycoengineered medicine designed to attack cells that have a certain marker (CD20) on their surface It attacks targeted cells both directly and together with the body’s immune system GA101 is currently being investigated in a large clinical program, including multiple head-to-head phase III studies versus MabThera/Rituxan in indolent non-Hodgkin lymphoma (NHL) and diffuse large B-cell lymphoma (DLBCL) In the U.S., GA101 is being developed and will be commercialized in collaboration with Biogen Idec About the CLL11 study CLL11 is a phase III, multicenter, open-label, randomized three-arm study investigating the efficacy and safety profile of either GA101 plus chlorambucil or MabThera/Rituxan plus chlorambucil compared to chlorambucil alone in 781 previously untreated people with CLL and co-existing medical conditions who are in need of therapy The study included two stages of analysis Stage 1 included 589 patients and compared GA101 plus chlorambucil to chlorambucil alone and MabThera/Rituxan plus chlorambucil to chlorambucil alone Stage 1 results were reported earlier this year and showed that GA101 plus chlorambucil doubled the time people lived without their disease worsening 23.0 vs 10.9 months compared to chlorambucil alone (HR=0.14 CI 0.09-0.21 p<0.0001) Stage 2 (announced today) enrolled an additional 192 patients to enable the final direct comparison of GA101 versus MabThera/Rituxan, both in combination with chlorambucil The primary endpoint of the study was PFS with secondary endpoints including overall response rate (ORR), overall survival (OS), disease-free survival (DFS), minimal residual disease (MRD) and safety profile About the German CLL Study Group (GCLLSG) Founded in 1996 and headed by Dr Michael Hallek, the GCLLSG has been running various phase III, phase II and phase I trials in CLL with the goal to provide optimal treatment to patients suffering from this disease Among those were landmark trials like the CLL8 trial which led to the current standard of care in CLL For many years, GCLLSG has been aiming to improve not just the treatment of younger and physically fit patients, but also that of elderly and less fit patients These patients are generally underrepresented in clinical trials although they constitute the majority of CLL patients treated by doctors in daily practice The GCLLSG is an independent non-profit research organization supported by the German Cancer Aid (Deutsche Krebshilfe).
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