Improve overall survival! Leukemia new drug phase 2 results are good
June 19, 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)];Headquartered in Tel Aviv, Israel, BiolineRX is a biopharmaceutical company focused on immunology and cancer. Today, at the 23rd European Association of Hematology (EHA) annual meeting in Stockholm, Sweden, BiolineRX announced a new phase 2a clinical trial of its candidate drug BL-8040. The results showed that BL-8040 combined with high-dose HiDAC (cytarabine) in the treatment of relapsed and refractory acute myeloid leukemia (r/r AML) significantly improved overall survival (OS). In addition, it was found that there was a statistically significant correlation between the remission after treatment and the mobilization of myeloblasts, that is, when the patient's remission was good, the number of myeloblasts in the peripheral blood increased significantly. vice versa.
AML is a rapidly deteriorating blood and bone marrow cancer characterized by uncontrolled proliferation of immature embryonic cells in the bone marrow. The American Cancer Society estimates that approximately 18,860 AML patients will be added in the United States in 2014, and approximately 10,460 people will die from AML, the vast majority of whom are adults. Among the diagnosed AML patients, the majority of the elderly over the age of 60, the average age is about 67 years. Treatment for this population is limited because most people are physically weak, unable to withstand standard induction chemotherapy, or have a disease that is currently resistant to effective drugs.
â–²BL-8040's mechanism of action on AML (Source: BioLineRx official website)
BL-8040 is a short peptide that can be used to treat AML and solid tumors, as well as to achieve stem cell mobilization. BL-8040 is a high affinity antagonist of the G protein coupled receptor CXCR4, a chemokine receptor directly involved in tumor progression, angiogenesis, cancer cell migration and survival. CXCR4 is overexpressed in more than 70% of human cancers, and its expression levels are often associated with disease severity. In many clinical and preclinical studies, BL-8040 has shown strong mobilization of cancer cells and immune cells from bone marrow, not only to make cancer cells sensitive to chemical and biological-based anticancer therapies, but also to induce cell death. (apoptosis) to directly fight cancer. In addition, BL-8040 also demonstrates strong stem cell mobilization properties that can mobilize colony forming cells, T, B and NK.
The reported phase 2a trial included 42 patients in two cohorts: cohort i, BL-8040 dose escalation group (0.5-2.0 mg/kg), and cohort ii, BL-8040 1.5 mg/kg dose extension group . Patients with r/r AML were treated with BL-8040 for two days, followed by HiDAC for 5 days for 1 to 2 cycles. The efficacy endpoints included response rate (CR/CRi), overall survival (OS), duration of remission (DOR), and event-free survival (EFS). The trial results showed that cohort i: all BL-8040 dose levels had a remission rate of 29%, a median OS of 9.1 months, and HiDAC alone had an OS of 6.1 months. Cohort ii: The response rate was 39%, the median OS was 10.7 months, and the 1-, 2-, and 3-year survival rates were 38.1%, 23.8%, and 23.8%, respectively. In addition, in the 9 patients who developed remission at a dose of 1.5 mg/kg of BL-8040, not only did the median OS increase significantly (OS was 21.8 months, 1-year, 2-year, and 3-year survival rates were 66.7%, respectively). , 44.4% and 44.4%), and the number of AML blasts in peripheral blood of patients also increased significantly by 6.3-fold (p = 0.003), but the mean increase of non-remission patients was 1.66-fold (p = 0.21, not significant).
â–²BioLineRx's R&D pipeline (Source: BioLineRx's official website)
BioLineRx CEO Philip Serlin said: "With the continuous accumulation of research data on the concept of r/r AML 2a, BioLineRx is very pleased to see further significant improvements in the OS of this very refractory patient population. In addition, exciting new findings indicate a clear correlation between the patient's response to BL-8040 and myeloblastic mobilization, so it is possible to identify potential biomarkers for patients who may respond to BL-8040. These encouraging results strongly support the further in-depth development of BL-8040 as a new r/r AML therapy, and also enable BioLineRx to have a wide range of therapeutic coverage in the AML field, covering different stages of the disease and different patient populations. Will continue to focus on the long-term overall survival of patients in this study. We are also continuing with two other important AML studies, including the Phase 1b/2 study to maintain AML (part of the collaboration with Genentech), and our efforts to consolidate AML. Phase 2b study."
We congratulate BioLineRx for the positive results and look forward to more new drugs to benefit AML patients.
Reference materials:
[1] BioLineRx Presents New Overall Survival Data From Phase 2a Study for BL-8040 in r/r AML Patients
[2] BioLineRx official website
[3] Excellent survival data, long-term follow-up results published by leukemia therapy
[4] Actinium treats AML new drugs for rapid approval
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