Prolonged overall survival, clinical results of stage 3 multiple myeloma were announced
January 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)];Amgen announced today that the positive overall survival (OS) results of the final phase of the ASPIRE Phase III clinical trial were published in the Journal of Clinical Oncology. This trial demonstrates that the combination of Kyprolis (carfilzomib) with lenalidomide and dexamethasone reduces mortality in patients with relapsed or refractory multiple myeloma and prolongs overall patient survival.
Multiple myeloma is a blood cancer that manifests as repeated remission and recurrence. It is a rare and aggressive disease that accounts for 1% of all cancer types. About 114,000 people worldwide are diagnosed with multiple myeloma each year, and 80,000 people die each year.
Kyprolis is a potent drug that blocks the proteasome. The proteasome plays an important role in the function and growth of cells and can break down proteins that are damaged or no longer needed. By blocking the action of the proteasome and causing excessive protein accumulation, Kyprolis can cause some cell death, especially myeloma cells, because these cells are more likely to contain large amounts of abnormal proteins. Currently, Kyprolis has been approved by the FDA for the treatment of relapsed or refractory multiple myeloma with dexamethasone or with lenalidomide plus dexamethasone. These patients have received first- to third-line treatment. It has also been approved for use alone in patients with relapsed or refractory multiple myeloma who have received first-line or multi-line therapy.
The International Random Phase 3 ASPIRE trial evaluated the combination of lenalidomide and dexamethasone (Rd) regimen with Kyprolis in combination with lenalidomide and dexamethasone (KRd) for one to three prior treatments. Patients with relapsed or refractory multiple myeloma. The primary endpoint of the trial was progression-free survival (PFS), defined as the time from treatment initiation to disease progression or death. Secondary endpoints included OS, overall response rate (ORR), duration of remission (DOR), disease control rate, health-related quality of life (HR-QoL), and safety. Patients were randomized to receive KYPROLIS. The study randomized 792 patients at locations in North America, Europe, and Israel.
The final analysis of ASPIRE included a subgroup analysis of patients receiving prior treatment regimens, including analysis of patients who had received multiple treatment regimens, Velocal (Bortezomib, bortezomib), and transplant recipients for the first relapse. Among the three groups, KRd reduced the risk of death by 18% to 29% compared with Rd, which is consistent with the overall population. Compared with patients receiving Rd, the median OS was extended by 11.4 months after KRd in patients who had received one treatment, and the median OS was extended by 6.5 months in patients who received two or more treatments (48.8 ratio) 42.3 months [HR = 0.79, 95% CI, 0.62-0.99]). Among patients who had previously received a treatment, patients who previously received Velcade had a median OS of 12 months compared with Rd patients after KRd (45.9 vs. 33.9 months [HR = 0.82; 95% CI, 0.56) - 1.19]), and in patients who had not previously received Velcade, the median OS of KRd patients was extended by 7.9 months (48.3 vs. 40.4 months [HR = 0.80, 95% CI, 0.55-1.17]). In addition, the median OS increased by 18.6 months (57.2 vs 38.6 months [HR = 0.71, 95% CI, 0.48-1.05]) after KRd in patients who underwent the first relapse. ASPIRE's security data is consistent with Kyprolis' known security data.
"The final analysis of the Phase 3 clinical trial ASPIRE published today in the Journal of Clinical Oncology is very important as they further validate Kyprolis, lenalidomide and dexamethasone as patients with relapsed or refractory multiple myeloma. The standard of care programs.†Keith Stewart, principal investigator of the ASPIRE trial at the Mayo Clinic in Arizona, said: “In addition, these data show that Kyprolis was used early, regardless of whether it was previously treated with Velcade or transplant therapy for the first relapse. Nalamine and dexamethasone can extend life to patients for almost a year."
“As seen in two different Phase 3 studies, the Kyprolis-based treatment regimen is the first and only one that can show significant overall survival advantage in patients with relapsed or refractory multiple myeloma. The treatment plan.†Dr. David M. Reese, Senior Vice President, Translational Science and Oncology, Amgen said: “We look forward to continuing our dialogue with the FDA to add these results to the Kyprolis label.â€
Based on a preliminary analysis of progression-free survival (PFS) in the ASPIRE study, the KRd protocol currently used in this trial has been approved by the US, EU and other countries. Amgen submitted a new drug application to the FDA and submitted a marketing application change to the European Medicines Agency to include the ASPIRE OS data in Kyprolis' product information.
Reference materials:
[1] Overall Survival Analysis From Amgen's KYPROLIS (Carfilzomib) Phase III ASPIRE Trial Published in the Journal of Clinical Oncology
[2] Amgen official website
[3] WuXi PharmaTech WeChat public number - extended overall survival! Multiple myeloma new drug reached the critical end point of 3
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