Say goodbye to chemotherapy! Aberdeen's new leukemia drug arrives at the end of phase 3
May 25, 2018 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Today, AbbVie announced that its Phase 3 clinical trial, iLLUMINATE (PCYC-1130), reached the primary endpoint of progression-free survival (PFS) improvement. This study evaluated the efficacy of Imbruvica (ibrutinib) in combination with Gazyva (obinutuzumab) in the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), the most common adult leukemia.
CLL is the most common form of leukemia in adults and is a cancer that develops from cells in the bone marrow that later mature into certain white blood cells (lymphocytes). Although these cancer cells begin in the bone marrow, they later spread into the bloodstream. The number of CLL patients in the United States is approximately 115,000, with approximately 19,000 new cases each year. SLL is a slow-growing lymphoma that is biologically similar to CLL, where too many immature white blood cells cause lymph nodes to become larger. CLL/SLL is mainly caused by the elderly, and the median age at diagnosis is 71 years. Currently, the treatment of CLL/SLL is still limited to chemotherapy. Once the disease recurs, the overall survival of such patients is usually only 2 to 3 years. There is still a huge medical need in this area that needs to be met.
Imbruvica (ibrutinib), a collaboration between Abbott Pharmacyclics and Janssen, is a first-in-class oral, once-daily therapy that blocks Bruton's tyrosine kinase (BTK). kick in. BTK is a key signaling molecule in the B cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells and other severely debilitating diseases. Imbruvica blocks signals that indicate the reproduction and spread of malignant B cells.
Currently, Imbruvica has been approved by the FDA for six different patient populations: CLL, SLL, Waldenstrom's macroglobulinemia (WM), and treated mantle cell lymphoma (MCL), marginal zone Lymphoma (MZL) and chronic graft-versus-host disease (cGVHD). It is worth mentioning that this WuXi PharmaTech Group Co., Ltd. has the privilege of assisting synthetic drugs to be marketed in China last year to treat patients with CLL/SLL/MCL who have received at least one treatment.
The current iLLUMINATE is a randomized, multicenter, open-label, phase 3 study evaluating the efficacy of chlorambucil and Gazyva combination therapy in patients with CLL/SLL initial treatment compared with Imbruvica and Gazyva. . In this study, patients were randomized to receive 6 consecutive cycles of Imbruvica 420 mg plus Gazyva 1000 mg, or chlorambucil plus Gazyva 1000 mg. The primary end point was the PFS assessed by the Independent Review Committee (IRC), and the secondary endpoints included overall response rate and minimum residual disease (MRD) negative response rate. The results showed that patients treated with Imbruvica plus Gazyva had significant clinical and statistical differences in PFS compared with controls, reaching the primary end point of the study.
"We are optimistic about the main results of the iLLUMINATE study and the fact that Imbruvica plus obinutuzumab showed significant progression-free survival compared to obinutuzumab plus chlorambucil. The combination therapy is currently recommended by the National Comprehensive Cancer Network (NCCN) guidelines. For Class 1 treatment, Dr. Danelle James, Head of Clinical Sciences at Pharmacyclics, Abbott said: "Since its introduction nearly five years ago, Imbruvica has been considered an important treatment option for CLL/SLL patients. At the same time, we now have CLL Long-term 5-year data. We are committed to developing the full potential of Imbruvica, either alone or in combination with various B-cell blood cancers."
“We are pleased to see positive results from the combination of ibrutinib plus obinutuzumab. This combination of no chemotherapy provides a potential new treatment option for patients with chronic lymphocytic leukemia,†said iLLUMINATE Principal Investigator, Barts Cancer Institute, UK, Oncology Professor John Gribben said: "It is a pleasure to see that the treatment of blood cancer continues to progress, and every advancement can provide patients with better treatment standards."
Based on these data, Pharmacyclics and Janssen are working with regulators to advance the regulation of the therapy. If approved, it will be the first CD20 combination therapy in the first-line CLL treatment that does not include chemotherapy. We look forward to the early arrival of this day, bringing the gospel to patients!
Reference materials:
[1] IMBRUVICA® (ibrutinib) Plus GAZYVA® (obinutuzumab) Phase 3 iLLUMINATE Trial for First-Line Therapy of Chronic Lymphocytic Leukemia (CLL) Patients Met Primary Endpoint
[2] PRESS | Congratulations! The new leukemia drug Imbruvica is listed in China
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