【drug-news】【资讯翻译】Kyprolis治疗晚期多发骨髓瘤多中心临床试验结果公布
发布于 2012-07-30 · 浏览 1421 · IP 北京北京
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http://www.drugs.com/clinical_trials/onyx-pharmaceuticals-announces-kyprolis-study-published-medical-journal-blood-14073.html
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SOUTH SAN FRANCISCO, Calif., July 25, 2012 /PRNewswire/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced today that Blood, the medical journal of the American Society of Hematology, has published results from the 003-A1 Phase 2b trial, a single-arm, multicenter clinical trial evaluating Kyprolis? (carfilzomib) for Injection for the treatment of patients with advanced multiple myeloma, who had received a median of five prior anti-myeloma regimens. The lead author was Dr. David Siegel, Chief of the Division of Multiple Myeloma at John Theurer Cancer Center at Hackensack University Medical Center.
On July 20, 2012, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Kyprolis for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent (IMiD), and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval was based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified. Full prescribing information is available at http://www.onyx.com.
About the 003-A1 Study
Two hundred and sixty-six patients with relapsed multiple myeloma who had received at least two prior therapies including bortezomib and an IMiD were enrolled in the open-label, single-arm 003-A1 Phase 2b study, and 257 patients were evaluable for response. The authors reported on the primary endpoint and secondary endpoints of the 003-A1 trial. The primary endpoint was overall response rate (ORR), defined as partial response (PR) or greater. The ORR was 23.7% among response-evaluable patients (n=257), and 22.9% among the total patient population (n=266). The median duration of response was 7.8 months. The most common treatment-emergent adverse events (AEs) reported in this study were fatigue (49%) and anemia (46%), and the most common Grade 3/4 AEs were thrombocytopenia (29%) and anemia (24%). The most common AEs of any grade possibly related to carfilzomib were fatigue (37%) and nausea (34%).
Data from the 003-A1 study were previously presented at the 52nd American Society of Hematology Annual Meeting in December 2010 and at subsequent international scientific meetings. The trial was conducted in collaboration with the Multiple Myeloma Research Consortium (MMRC) and at additional sites in the United States and Canada.
Important Safety Information Regarding Kyprolis? (carfilzomib) for Injection
Safety data have been evaluated in 526 patients with relapsed and/or refractory multiple myeloma who received single-agent carfilzomib. There were 37 deaths in the phase 2 studies, or 7% of patients. The most common causes of death, other than disease progression, were cardiac (5 patients), end-organ failure (4 patients), and infection (4 patients). Important warnings and precautions include cardiac arrest, congestive heart failure, myocardial ischemia; pulmonary hypertension, pulmonary complications, infusion reactions, tumor lysis syndrome, thrombocytopenia, hepatic toxicity and embryo-fetal toxicity.
Death due to cardiac arrest has occurred within a day of Kyprolis administration. Patients with New York Heart Association Class III and IV heart failure, myocardial infarction in the preceding 6 months, and conduction abnormalities uncontrolled by medications were not eligible for the clinical trials. These patients may be at greater risk for cardiac complications.
Pulmonary arterial hypertension (PAH) was reported in 2% of patients treated with Kyprolis and was Grade 3 or greater in less than 1% of patients. Dyspnea was reported in 35% of patients enrolled in clinical trials. Grade 3 dyspnea occurred in 5%; no Grade 4 events, and 1 death (Grade 5) was reported.
Infusion reactions, characterized by a spectrum of systemic symptoms including fever, chills, arthralgia, myalgia, facial flushing, facial edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina can occur immediately following or up to 24 hours after administration of Kyprolis. Administration of dexamethasone prior to Kyprolis reduces the incidence and severity of reactions. Tumor lysis syndrome (TLS) occurred following Kyprolis administration in < 1% of patients. Patients with multiple myeloma and a high tumor burden should be considered to be at greater risk for TLS.
Thrombocytopenia following Kyprolis administration resulted in a dose reduction in 1% of patients and discontinuation of treatment with Kyprolis in < 1% of patients.
Cases of hepatic failure, including fatal cases, have been reported (< 1%). Kyprolis can cause elevations of serum transaminases and bilirubin.
There are no adequate and well-controlled studies in pregnant women using Kyprolis. Females of reproductive potential should be advised to avoid becoming pregnant while being treated with Kyprolis.
The most common serious adverse reactions were pneumonia, acute renal failure, pyrexia, and congestive heart failure. The most common adverse reactions (incidence of 30% or greater) observed in clinical trials of patients with multiple myeloma were fatigue, anemia, nausea, thrombocytopenia, dyspnea, diarrhea, and pyrexia. Serious adverse reactions were reported in 45% of patients.
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请根据自己的专业背景选择相应的资讯认领，经常认领而不能及时提供优质稿件者将被列入黑名单，取消认领资格，请大家注意！
新近参与本次活动的会员请查看：【公告】动态版重启资讯翻译计划：我为人人，人人为我，共同提高
寻找最近的翻译贴请查看：http://search.dxy.cn/?words=%E8%B5%84%E8%AE%AF%E7%BF%BB%E8%AF%91&bid=116&t=1&c=1&age=7&bid=116&limit=30&o=1
翻译时请参照版规 【版务】科技动态版版规及加分细则（ 2014-02-21 更新）
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SOUTH SAN FRANCISCO, Calif., July 25, 2012 /PRNewswire/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced today that Blood, the medical journal of the American Society of Hematology, has published results from the 003-A1 Phase 2b trial, a single-arm, multicenter clinical trial evaluating Kyprolis? (carfilzomib) for Injection for the treatment of patients with advanced multiple myeloma, who had received a median of five prior anti-myeloma regimens. The lead author was Dr. David Siegel, Chief of the Division of Multiple Myeloma at John Theurer Cancer Center at Hackensack University Medical Center.
On July 20, 2012, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Kyprolis for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent (IMiD), and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval was based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified. Full prescribing information is available at http://www.onyx.com.
About the 003-A1 Study
Two hundred and sixty-six patients with relapsed multiple myeloma who had received at least two prior therapies including bortezomib and an IMiD were enrolled in the open-label, single-arm 003-A1 Phase 2b study, and 257 patients were evaluable for response. The authors reported on the primary endpoint and secondary endpoints of the 003-A1 trial. The primary endpoint was overall response rate (ORR), defined as partial response (PR) or greater. The ORR was 23.7% among response-evaluable patients (n=257), and 22.9% among the total patient population (n=266). The median duration of response was 7.8 months. The most common treatment-emergent adverse events (AEs) reported in this study were fatigue (49%) and anemia (46%), and the most common Grade 3/4 AEs were thrombocytopenia (29%) and anemia (24%). The most common AEs of any grade possibly related to carfilzomib were fatigue (37%) and nausea (34%).
Data from the 003-A1 study were previously presented at the 52nd American Society of Hematology Annual Meeting in December 2010 and at subsequent international scientific meetings. The trial was conducted in collaboration with the Multiple Myeloma Research Consortium (MMRC) and at additional sites in the United States and Canada.
Important Safety Information Regarding Kyprolis? (carfilzomib) for Injection
Safety data have been evaluated in 526 patients with relapsed and/or refractory multiple myeloma who received single-agent carfilzomib. There were 37 deaths in the phase 2 studies, or 7% of patients. The most common causes of death, other than disease progression, were cardiac (5 patients), end-organ failure (4 patients), and infection (4 patients). Important warnings and precautions include cardiac arrest, congestive heart failure, myocardial ischemia; pulmonary hypertension, pulmonary complications, infusion reactions, tumor lysis syndrome, thrombocytopenia, hepatic toxicity and embryo-fetal toxicity.
Death due to cardiac arrest has occurred within a day of Kyprolis administration. Patients with New York Heart Association Class III and IV heart failure, myocardial infarction in the preceding 6 months, and conduction abnormalities uncontrolled by medications were not eligible for the clinical trials. These patients may be at greater risk for cardiac complications.
Pulmonary arterial hypertension (PAH) was reported in 2% of patients treated with Kyprolis and was Grade 3 or greater in less than 1% of patients. Dyspnea was reported in 35% of patients enrolled in clinical trials. Grade 3 dyspnea occurred in 5%; no Grade 4 events, and 1 death (Grade 5) was reported.
Infusion reactions, characterized by a spectrum of systemic symptoms including fever, chills, arthralgia, myalgia, facial flushing, facial edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina can occur immediately following or up to 24 hours after administration of Kyprolis. Administration of dexamethasone prior to Kyprolis reduces the incidence and severity of reactions. Tumor lysis syndrome (TLS) occurred following Kyprolis administration in < 1% of patients. Patients with multiple myeloma and a high tumor burden should be considered to be at greater risk for TLS.
Thrombocytopenia following Kyprolis administration resulted in a dose reduction in 1% of patients and discontinuation of treatment with Kyprolis in < 1% of patients.
Cases of hepatic failure, including fatal cases, have been reported (< 1%). Kyprolis can cause elevations of serum transaminases and bilirubin.
There are no adequate and well-controlled studies in pregnant women using Kyprolis. Females of reproductive potential should be advised to avoid becoming pregnant while being treated with Kyprolis.
The most common serious adverse reactions were pneumonia, acute renal failure, pyrexia, and congestive heart failure. The most common adverse reactions (incidence of 30% or greater) observed in clinical trials of patients with multiple myeloma were fatigue, anemia, nausea, thrombocytopenia, dyspnea, diarrhea, and pyrexia. Serious adverse reactions were reported in 45% of patients.
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