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在ECHO III期试验中,CALQUENCE联合方案显示一线套细胞淋巴瘤的无进展生存率有统计学意义和临床意义的改善

CALQUENCE combination regimen demonstrated statistically significant and clinically meaningful improvement in progression-free survival in 1st-line mantle cell lymphoma in ECHO Phase III trial

businesswire | 2024-05-02 | 翻译由动脉网AI生成,点击反馈

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WILMINGTON, Del.--(BUSINESS WIRE)--Positive high-level results from an interim analysis of the ECHO Phase III trial showed AstraZeneca’s CALQUENCE® (acalabrutinib) in combination with standard-of-care chemoimmunotherapy, bendamustine and rituximab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus standard of care in previously untreated adult patients with mantle cell lymphoma (MCL)..

威尔明顿,Del。--(商业新闻短讯)-ECHO III期临床试验中期分析的阳性高水平结果显示,阿斯利康的CALQUENCE®(阿卡鲁替尼)联合标准治疗化学免疫疗法,苯达莫司汀和利妥昔单抗,在先前未经治疗的套细胞淋巴瘤(MCL)成年患者中,与标准治疗相比,无进展生存期(PFS)有统计学意义和临床意义的改善。。

A trend was observed in favor of CALQUENCE plus chemoimmunotherapy for the secondary endpoint of overall survival (OS). The OS data were not mature at the time of this analysis and the trial will continue to assess OS.

观察到有利于CALQUENCE加化学免疫疗法治疗总生存期(OS)次要终点的趋势。在进行分析时,操作系统数据还不成熟,试验将继续评估操作系统。

MCL is a rare and typically aggressive form of non-Hodgkin lymphoma (NHL), often diagnosed as a late-stage disease, resulting when B-lymphocytes mutate into malignant cells within a region of the lymph node known as the mantle zone.1,2 It is estimated that there are more than 27,500 patients diagnosed with MCL worldwide.3,4.

MCL是一种罕见且典型的侵袭性非霍奇金淋巴瘤(NHL),通常被诊断为晚期疾病,当B淋巴细胞在称为套区的淋巴结区域内突变为恶性细胞时产生[1,2]。据估计,全世界有超过27500名被诊断患有MCL的患者[3,4]。

Michael Wang, MD, Puddin Clarke Endowed Professor, Director of Mantle Cell Lymphoma Program of Excellence, Co-Director of Clinical Trials at MD Anderson Cancer Center in Houston, US and principal investigator in the trial, said: “These positive progression-free survival results from the ECHO Phase III trial could provide a new standard of care for patients with mantle cell lymphoma.

MichaelWang,医学博士,PuddinClarke Endered教授,套细胞淋巴瘤卓越计划主任,美国休斯顿MD安德森癌症中心临床试验联合主任,该试验的主要研究者说:“ECHO III期试验的这些阳性无进展生存结果可以为套细胞淋巴瘤患者提供新的护理标准。

Incorporating CALQUENCE into the first-line mantle cell lymphoma setting would give many more patients the opportunity to benefit from the robust efficacy and strong safety profile we’ve seen with this medicine.”.

将CALQUENCE纳入一线套细胞淋巴瘤环境将使更多的患者有机会受益于这种药物的强大疗效和强大的安全性。”。

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “These impactful results in mantle cell lymphoma show that bringing CALQUENCE to the first-line setting significantly delays disease progression and, for the first time, shows potential to extend survival. The improvement in progression-free survival together with the differentiated safety profile of CALQUENCE are both important as we strive to transform outcomes earlier in the course of disease treatment.”.

阿斯利康肿瘤研发执行副总裁苏珊·加尔布雷斯(SusanGalbraith)表示:“套细胞淋巴瘤的这些有影响力的结果表明,将CALQUENCE纳入一线治疗可以显着延缓疾病进展,并首次显示出延长生存期的潜力。随着我们努力在疾病治疗过程中尽早改变结果,无进展生存期的改善以及CALQUENCE的差异化安全性都很重要。”。

The safety and tolerability of CALQUENCE was consistent with its known safety profile, and no new safety signals were identified.

CALQUENCE的安全性和耐受性与其已知的安全性一致,并且没有发现新的安全信号。

The data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

这些数据将在即将举行的医疗会议上提交,并与全球监管机构共享。

As part of an extensive clinical development program, AstraZeneca is currently evaluating CALQUENCE alone and in combination for the treatment of multiple B-cell blood cancers, including chronic lymphocytic leukemia (CLL), MCL, and diffuse large B-cell lymphoma.

作为广泛临床开发计划的一部分,阿斯利康目前正在评估单独或联合使用CALQUENCE治疗多种B细胞血癌,包括慢性淋巴细胞白血病(CLL),MCL和弥漫性大B细胞淋巴瘤。

CALQUENCE has been used to treat more than 80,000 patients worldwide and is approved for the treatment of CLL and small lymphocytic lymphoma (SLL) in the US, approved for CLL in the EU and many other countries worldwide and approved in Japan and China for relapsed or refractory CLL and SLL. CALQUENCE is also approved in the US, China and several other countries for the treatment of adult patients with MCL who have received at least one prior therapy.

CALQUENCE已被用于治疗全球80000多名患者,并在美国被批准用于治疗CLL和小淋巴细胞淋巴瘤(SLL),在欧盟和全球许多其他国家被批准用于CLL,在日本和中国被批准用于复发或难治性CLL和SLL。CALQUENCE在美国,中国和其他几个国家也被批准用于治疗至少接受过一次治疗的成年MCL患者。

CALQUENCE is not currently approved for the treatment of MCL in Japan or the EU..

CALQUENCE目前尚未在日本或欧盟批准用于治疗MCL。。

INDICATIONS AND USAGE

适应症和用法

CALQUENCE is a Bruton tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

CALQUENCE是一种布鲁顿酪氨酸激酶(BTK)抑制剂,用于治疗至少接受过一次治疗的成年套细胞淋巴瘤(MCL)患者。

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

根据总体回复率,该适应症在加速批准下获得批准。继续批准该适应症可能取决于验证性试验中临床益处的验证和描述。

CALQUENCE is also indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

CALQUENCE也适用于治疗成人慢性淋巴细胞白血病(CLL)或小淋巴细胞淋巴瘤(SLL)患者。

IMPORTANT SAFETY INFORMATION ABOUT CALQUENCE® (acalabrutinib) tablets

关于CALQUENCE®(acalabrutinib)片剂的重要安全信息

Serious and Opportunistic Infections

严重和机会性感染

Fatal and serious infections, including opportunistic infections, have occurred in patients with hematologic malignancies treated with CALQUENCE.

用CALQUENCE治疗的血液系统恶性肿瘤患者发生致命和严重感染,包括机会性感染。

Serious or Grade 3 or higher infections (bacterial, viral, or fungal) occurred in 19% of 1029 patients exposed to CALQUENCE in clinical trials, most often due to respiratory tract infections (11% of all patients, including pneumonia in 6%). These infections predominantly occurred in the absence of Grade 3 or 4 neutropenia, with neutropenic infection reported in 1.9% of all patients.

在临床试验中暴露于CALQUENCE的1029名患者中,有19%发生严重或3级或更高级别的感染(细菌,病毒或真菌),最常见的原因是呼吸道感染(占所有患者的11%,包括6%的肺炎)。这些感染主要发生在没有3级或4级中性粒细胞减少症的情况下,据报道所有患者中有1.9%患有中性粒细胞减少症。

Opportunistic infections in recipients of CALQUENCE have included, but are not limited to, hepatitis B virus reactivation, fungal pneumonia, Pneumocystis jirovecii pneumonia, Epstein-Barr virus reactivation, cytomegalovirus, and progressive multifocal leukoencephalopathy (PML). Consider prophylaxis in patients who are at increased risk for opportunistic infections.

CALQUENCE受者的机会性感染包括但不限于乙型肝炎病毒再激活,真菌性肺炎,肺孢子虫肺炎,爱泼斯坦-巴尔病毒再激活,巨细胞病毒和进行性多灶性白质脑病(PML)。考虑对机会性感染风险增加的患者进行预防。

Monitor patients for signs and symptoms of infection and treat promptly..

监测患者的感染体征和症状,并及时治疗。。

Hemorrhage

出血

Fatal and serious hemorrhagic events have occurred in patients with hematologic malignancies treated with CALQUENCE. Major hemorrhage (serious or Grade 3 or higher bleeding or any central nervous system bleeding) occurred in 3.0% of patients, with fatal hemorrhage occurring in 0.1% of 1029 patients exposed to CALQUENCE in clinical trials.

用CALQUENCE治疗的血液系统恶性肿瘤患者发生了致命和严重的出血事件。3.0%的患者发生大出血(严重或3级或更高级别出血或任何中枢神经系统出血),在临床试验中暴露于CALQUENCE的1029名患者中,有0.1%发生致命出血。

Bleeding events of any grade, excluding bruising and petechiae, occurred in 22% of patients..

22%的患者发生任何程度的出血事件,不包括瘀伤和瘀斑。。

Use of antithrombotic agents concomitantly with CALQUENCE may further increase the risk of hemorrhage. In clinical trials, major hemorrhage occurred in 2.7% of patients taking CALQUENCE without antithrombotic agents and 3.6% of patients taking CALQUENCE with antithrombotic agents. Consider the risks and benefits of antithrombotic agents when co-administered with CALQUENCE.

同时使用抗血栓药物可能会进一步增加出血风险。在临床试验中,服用不含抗血栓药物的CALQUENCE的患者中有2.7%发生大出血,服用抗血栓药物的患者中有3.6%发生大出血。考虑与CALQUENCE共同给药时抗血栓药物的风险和益处。

Monitor patients for signs of bleeding..

监测患者是否有出血迹象。。

Consider the benefit-risk of withholding CALQUENCE for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

根据手术类型和出血风险,考虑手术前后3-7天停止计算的益处风险。

Cytopenias

血细胞减少

Grade 3 or 4 cytopenias, including neutropenia (23%), anemia (8%), thrombocytopenia (7%), and lymphopenia (7%), developed in patients with hematologic malignancies treated with CALQUENCE. Grade 4 neutropenia developed in 12% of patients. Monitor complete blood counts regularly during treatment. Interrupt treatment, reduce the dose, or discontinue treatment as warranted..

用CALQUENCE治疗的血液系统恶性肿瘤患者发生3或4级血细胞减少症,包括中性粒细胞减少症(23%),贫血(8%),血小板减少症(7%)和淋巴细胞减少症(7%)。12%的患者出现4级中性粒细胞减少症。在治疗期间定期监测全血细胞计数。中断治疗,减少剂量,或根据需要停止治疗。。

Second Primary Malignancies

第二原发恶性肿瘤

Second primary malignancies, including skin cancers and other solid tumors, occurred in 12% of 1029 patients exposed to CALQUENCE in clinical trials. The most frequent second primary malignancy was skin cancer, reported in 6% of patients. Monitor patients for skin cancers and advise protection from sun exposure..

在临床试验中暴露于CALQUENCE的1029名患者中,有12%发生了第二原发性恶性肿瘤,包括皮肤癌和其他实体瘤。最常见的第二原发性恶性肿瘤是皮肤癌,据报道有6%的患者。监测患者的皮肤癌并建议避免阳光照射。。

Atrial Fibrillation and Flutter

心房颤动和扑动

Grade 3 atrial fibrillation or flutter occurred in 1.1% of 1029 patients treated with CALQUENCE, with all grades of atrial fibrillation or flutter reported in 4.1% of all patients. The risk may be increased in patients with cardiac risk factors, hypertension, previous arrhythmias, and acute infection.

1029例接受CALQUENCE治疗的患者中有1.1%发生3级心房颤动或扑动,所有级别的心房颤动或扑动报告率为4.1%。患有心脏危险因素,高血压,既往心律失常和急性感染的患者的风险可能会增加。

Monitor for symptoms of arrhythmia (eg, palpitations, dizziness, syncope, dyspnea) and manage as appropriate..

监测心律失常症状(如心悸、头晕、晕厥、呼吸困难)并酌情处理。。

ADVERSE REACTIONS

不良反应

The most common adverse reactions (≥20%) of any grade in patients with relapsed or refractory MCL were anemia,* thrombocytopenia,* headache (39%), neutropenia,* diarrhea (31%), fatigue (28%), myalgia (21%), and bruising (21%). The most common Grade ≥3 non-hematological adverse reaction (reported in at least 2% of patients) was diarrhea (3.2%)..

复发或难治性MCL患者最常见的不良反应(≥20%)是贫血,*血小板减少症,*头痛(39%),中性粒细胞减少症,*腹泻(31%),疲劳(28%),肌痛(21%)和瘀伤(21%)。最常见的≥3级非血液学不良反应(至少2%的患者报告)是腹泻(3.2%)。。

*Treatment-emergent decreases (all grades) of hemoglobin (46%), platelets (44%), and neutrophils (36%) were based on laboratory measurements and adverse reactions.

*血红蛋白(46%),血小板(44%)和中性粒细胞(36%)的治疗紧急下降(所有等级)是基于实验室测量和不良反应。

Dose reductions or discontinuations due to any adverse reaction were reported in 1.6% and 6.5% of patients, respectively. Increases in creatinine to 1.5 to 3 times the upper limit of normal (ULN) occurred in 4.8% of patients.

据报道,分别有1.6%和6.5%的患者因任何不良反应而减少剂量或停药。4.8%的患者肌酐升高至正常上限(ULN)的1.5至3倍。

The most common adverse reactions (≥30%) of any grade in patients with CLL were anemia,* neutropenia,* thrombocytopenia,* headache, upper respiratory tract infection, and diarrhea.

CLL患者最常见的不良反应(≥30%)是贫血,*中性粒细胞减少症,*血小板减少症,*头痛,上呼吸道感染和腹泻。

*Treatment-emergent decreases (all grades) of hemoglobin, platelets, and neutrophils were based on laboratory measurements and adverse reactions.

*血红蛋白,血小板和中性粒细胞的治疗紧急减少(所有等级)是基于实验室测量和不良反应。

In patients with previously untreated CLL exposed to CALQUENCE, fatal adverse reactions that occurred in the absence of disease progression and with onset within 30 days of the last study treatment were reported in 2% for each treatment arm, most often from infection. Serious adverse reactions were reported in 39% of patients in the CALQUENCE plus obinutuzumab arm and 32% in the CALQUENCE monotherapy arm, most often due to events of pneumonia (7% and 2.8%, respectively)..

在先前未经治疗的CLL暴露于CALQUENCE的患者中,在没有疾病进展的情况下发生的致命不良反应以及在最后一次研究治疗后30天内发作的致命不良反应报告为每个治疗组2%,最常见的是感染。CALQUENCE加obinutuzumab组39%的患者和CALQUENCE单药治疗组32%的患者报告了严重的不良反应,最常见的原因是肺炎事件(分别为7%和2.8%)。。

Adverse reactions led to CALQUENCE dose reduction in 7% and 4% of patients in the CALQUENCE plus obinutuzumab arm (N=178) and CALQUENCE monotherapy arm (N=179), respectively. Adverse events led to discontinuation in 11% and 10% of patients, respectively. Increases in creatinine to 1.5 to 3 times ULN occurred in 3.9% and 2.8% of patients in the CALQUENCE combination arm and monotherapy arm, respectively..

不良反应分别导致CALQUENCE加obinutuzumab组(N=178)和CALQUENCE单药治疗组(N=179)中7%和4%的患者的CALQUENCE剂量减少。不良事件分别导致11%和10%的患者停药。CALQUENCE联合治疗组和单药治疗组分别有3.9%和2.8%的患者肌酐增加至ULN的1.5至3倍。。

In patients with relapsed/refractory CLL exposed to CALQUENCE, serious adverse reactions occurred in 29% of patients. Serious adverse reactions in >5% of patients who received CALQUENCE included lower respiratory tract infection (6%). Fatal adverse reactions within 30 days of the last dose of CALQUENCE occurred in 2.6% of patients, including from second primary malignancies and infection..

在复发/难治性CLL暴露于CALQUENCE的患者中,29%的患者发生严重不良反应。接受CALQUENCE治疗的患者中>5%的严重不良反应包括下呼吸道感染(6%)。2.6%的患者在最后一剂CALQUENCE后30天内发生致命的不良反应,包括第二原发性恶性肿瘤和感染。。

Adverse reactions led to CALQUENCE dose reduction in 3.9% of patients (N=154), dose interruptions in 34% of patients, most often due to respiratory tract infections followed by neutropenia, and discontinuation in 10% of patients, most frequently due to second primary malignancies followed by infection.

不良反应导致3.9%的患者(N=154)的剂量减少,34%的患者剂量中断,最常见的是由于呼吸道感染,其次是中性粒细胞减少,10%的患者停药,最常见的是由于第二原发性恶性肿瘤,其次是感染。

Increases in creatinine to 1.5 to 3 times ULN occurred in 1.3% of patients who received CALQUENCE..

1.3%接受CALQUENCE治疗的患者肌酐增加至ULN的1.5至3倍。。

DRUG INTERACTIONS

药物相互作用

Strong CYP3A Inhibitors: Avoid co-administration of CALQUENCE with a strong CYP3A inhibitor. If these inhibitors will be used short-term, interrupt CALQUENCE. After discontinuation of strong CYP3A inhibitor for at least 24 hours, resume previous dosage of CALQUENCE.

强CYP3A抑制剂:避免将CALQUENCE与强CYP3A抑制剂共同给药。如果这些抑制剂将短期使用,请中断计算。停用强CYP3A抑制剂至少24小时后,恢复先前剂量的CALQUENCE。

Moderate CYP3A Inhibitors: Reduce the dosage of CALQUENCE to 100 mg once daily when co-administered with a moderate CYP3A inhibitor.

中度CYP3A抑制剂:与中度CYP3A抑制剂共同给药时,每天一次将CALQUENCE的剂量减少至100 mg。

Strong CYP3A Inducers: Avoid co-administration of CALQUENCE with a strong CYP3A inducer. If co-administration is unavoidable, increase the dosage of CALQUENCE to 200 mg approximately every 12 hours.

强CYP3A诱导剂:避免将CALQUENCE与强CYP3A诱导剂共同给药。如果无法避免共同给药,则大约每12小时将CALQUENCE的剂量增加至200 mg。

SPECIFIC POPULATIONS

特定人群

Based on findings in animals, CALQUENCE may cause fetal harm and dystocia when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. Advise pregnant women of the potential risk to a fetus.

根据动物的研究结果,CALQUENCE给孕妇服用时可能会导致胎儿伤害和难产。孕妇中没有可用的数据来告知与药物相关的风险。告知孕妇对胎儿的潜在风险。

Pregnancy testing is recommended for females of reproductive potential prior to initiating CALQUENCE therapy. Advise female patients of reproductive potential to use effective contraception during treatment with CALQUENCE and for 1 week following the last dose of CALQUENCE.

在开始CALQUENCE治疗之前,建议对具有生殖潜力的女性进行妊娠测试。建议有生殖潜力的女性患者在使用CALQUENCE治疗期间和最后一剂CALQUENCE后1周内使用有效的避孕措施。

It is not known if CALQUENCE is present in human milk. Advise lactating women not to breastfeed while taking CALQUENCE and for 2 weeks after the last dose.

目前尚不清楚母乳中是否存在CALQUENCE。建议哺乳期妇女服用CALQUENCE时以及服用最后一剂后2周内不要母乳喂养。

Avoid use of CALQUENCE in patients with severe hepatic impairment (Child-Pugh class C). No dosage adjustment of CALQUENCE is recommended in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.

避免在严重肝功能损害(Child-Pugh C级)患者中使用CALQUENCE。轻度(Child-Pugh A级)或中度(Child-Pugh B级)肝损伤患者不建议调整剂量。

Please see full Prescribing Information, including Patient Information.

请参阅完整的处方信息,包括患者信息。

Notes

注意事项

Mantle cell lymphoma

套细胞淋巴瘤

MCL is an uncommon subtype of B-cell non-Hodgkin lymphoma.5 MCL comprises about 3-6% of non-Hodgkin lymphomas, with an annual incidence of 0.5 per 100,000 population in Western countries; in the US, it is estimated that approximately 4,000 new cases of MCL are diagnosed each year.5,6 While MCL patients initially respond to treatment, patients do tend to relapse.5.

MCL是B细胞非霍奇金淋巴瘤的一种罕见亚型[5]。MCL约占非霍奇金淋巴瘤的3-6%,西方国家每10万人年发病率为0.5;在美国,估计每年约有4000例新发MCL病例被诊断出来[5,6]。虽然MCL患者最初对治疗有反应,但患者确实倾向于复发。

ECHO

回声

ECHO is a randomized, double-blind, placebo-controlled, multi-center Phase III trial evaluating the efficacy and safety of CALQUENCE plus bendamustine and rituximab compared to standard of care chemoimmunotherapy (bendamustine and rituximab) in adult patients at or over 65 years of age (n=598) with previously untreated MCL.7 In the experimental arms, patients were randomized 1:1 to receive either CALQUENCE or placebo administered orally twice per day, on days 1 and 2 of each 28 day treatment cycle, plus bendamustine on days 1 and 2 and rituximab on day 1.

ECHO是一项随机,双盲,安慰剂对照,多中心III期临床试验,评估CALQUENCE加苯达莫司汀和利妥昔单抗与标准护理化学免疫疗法(苯达莫司汀和利妥昔单抗)相比在65岁或以上的成年患者中的疗效和安全性(n=598)以前未经治疗的MCL。在实验组中,患者被随机分配1:1,每天两次口服CALQUENCE或安慰剂,在每个28天治疗周期的第1天和第2天,在第1天和第2天加上苯达莫司汀,在第1天服用利妥昔单抗。

After six cycles of CALQUENCE or placebo in combination with bendamustine and rituximab, patients receive CALQUENCE or placebo plus maintenance rituximab for two years and then either CALQUENCE or placebo only until disease progression.7.

在六个周期的CALQUENCE或安慰剂联合苯达莫司汀和利妥昔单抗治疗后,患者接受CALQUENCE或安慰剂加利妥昔单抗维持治疗两年,然后仅接受CALQUENCE或安慰剂治疗直至疾病进展。

The primary endpoint is PFS and key secondary endpoints include OS, overall response rate (ORR), duration of response (DoR) and time to response (TTR).7 The trial includes 27 countries across North and South America, Europe, Asia and Oceania.7

主要终点是PFS,关键次要终点包括OS,总体缓解率(ORR),缓解持续时间(DoR)和缓解时间(TTR)[7]。该试验包括北美和南美,欧洲,亚洲和大洋洲的27个国家

The ECHO trial was conducted from 2017 to 2023 continuing through the COVID-19 pandemic. Patients with blood cancer remain at a disproportionately high risk of severe outcomes from COVID-19, including hospitalization and death compared to the general population.8

ECHO试验于2017年至2023年进行,持续到新型冠状病毒大流行。与普通人群相比,血癌患者仍然处于COVID-19严重后果的不成比例的高风险中,包括住院和死亡

CALQUENCE

calequence

CALQUENCE (acalabrutinib) is a next-generation, selective inhibitor of Bruton’s tyrosine kinase (BTK). CALQUENCE binds covalently to BTK, thereby inhibiting its activity.9 In B cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion..

CALQUENCE(acalabrutinib)是布鲁顿酪氨酸激酶(BTK)的下一代选择性抑制剂。CALQUENCE与BTK共价结合,从而抑制其活性。在B细胞中,BTK信号传导导致B细胞增殖,运输,趋化性和粘附所必需的途径的激活。。

AstraZeneca in hematology

阿斯利康血液学

AstraZeneca is pushing the boundaries of science to redefine care in hematology. We have expanded our commitment to patients with hematologic conditions, not only in oncology but also in rare diseases with the acquisition of Alexion, allowing us to reach more patients with high unmet needs. By applying our deep understanding of blood cancers, leveraging our strength in solid tumor oncology and delivering on Alexion’s pioneering legacy in complement science to provide innovative medicines for rare diseases, we are pursuing the end-to-end development of novel therapies designed to target underlying drivers of disease.

阿斯利康正在推动科学界重新定义血液学护理。我们扩大了对血液病患者的承诺,不仅在肿瘤学方面,而且在获得Alexion后的罕见疾病方面,使我们能够接触到更多未满足需求的患者。通过应用我们对血癌的深刻理解,利用我们在实体瘤肿瘤学方面的优势,并利用亚力兄在补体科学方面的开创性遗产,为罕见疾病提供创新药物,我们正在寻求针对疾病潜在驱动因素的新型疗法的端到端开发。

Following AstraZeneca’s recent acquisition of Gracell Biotechnologies Inc., we have broadened our pipeline of innovative cell therapies with a differentiated manufacturing process to potentially further address hematologic malignancies..

在阿斯利康最近收购Gracell Biotechnologies Inc.之后,我们扩大了创新细胞疗法的渠道,采用了差异化的制造工艺,以进一步解决血液系统恶性肿瘤。。

By targeting hematologic conditions with high unmet medical needs, we aim to deliver innovative medicines and approaches to improve patient outcomes. Our goal is to help transform the lives of patients living with malignant, rare and other related hematologic diseases, shaped by insights from patients, caregivers and physicians to have the most meaningful impact..

通过针对高度未满足医疗需求的血液病,我们的目标是提供创新的药物和方法来改善患者的预后。我们的目标是帮助改变患有恶性,罕见和其他相关血液疾病的患者的生活,这些疾病由患者,护理人员和医生的见解塑造,产生最有意义的影响。。

AstraZeneca in oncology

阿斯利康肿瘤学

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

阿斯利康(AstraZeneca)正在领导一场肿瘤学革命,致力于为各种形式的癌症提供治疗,遵循科学理解癌症及其复杂性,发现、开发并向患者提供改变生命的药物。

The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.

该公司专注于一些最具挑战性的癌症。正是通过不断的创新,阿斯利康建立了行业内最多样化的投资组合和渠道之一,有可能催化医学实践的变化并改变患者的体验。

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

阿斯利康的愿景是重新定义癌症护理,并有一天消除癌症作为死亡原因。

AstraZeneca

阿斯利康

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.

阿斯利康(LSE/STO/Nasdaq:AZN)是一家全球科学领先的生物制药公司,专注于肿瘤学,罕见病和生物制药(包括心血管,肾脏和代谢以及呼吸和免疫学)处方药的发现,开发和商业化。

Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit www.astrazeneca-us.com and follow the Company on social media @AstraZeneca..

阿斯利康总部位于英国剑桥,在100多个国家运营,其创新药物被全球数百万患者使用。请访问www.astrazeneca-us.com并在社交媒体@astrazeneca上关注公司。。

References

参考文献

Lymphoma Research Foundation. Mantle Cell Lymphoma. Available at: https://lymphoma.org/aboutlymphoma/nhl/mcl/. Accessed April 2024.

淋巴瘤研究基金会。套细胞淋巴瘤。网址:https://lymphoma.org/aboutlymphoma/nhl/mcl/.2024年4月访问。

National Organization for Rare Disorders. Mantle Cell Lymphoma. Available at: https://rarediseases.org/rare-diseases/mantle-cell-lymphoma/. Accessed April 2024.

国家罕见疾病组织。套细胞淋巴瘤。网址:https://rarediseases.org/rare-diseases/mantle-cell-lymphoma/.2024年4月访问。

GLOBOCAN. Non-Hodgkin Lymphoma. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf. Accessed April 2024.

GLOBOCAN公司。非霍奇金淋巴瘤。网址:https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf.2024年4月访问。

Lynch DT, Koya S, Acharya U, et al. Mantle Cell Lymphoma. Available at: https://www.ncbi.nlm.nih.gov/books/NBK536985/. Accessed April 2024.

Lynch DT,Koya S,Acharya U等。套细胞淋巴瘤。网址:https://www.ncbi.nlm.nih.gov/books/NBK536985/.2024年4月访问。

Cheah C, Seymour J, Wang ML. Mantle cell lymphoma. J Clin Oncol. 2016;34(11):1256-1269. doi: 10.1200/JCO.2015.63.5904.

Cheah C,Seymour J,Wang ML.套细胞淋巴瘤。J临床肿瘤学。2016年;34(11):1256-1269。doi:10.1200/JCO.2015.63.5904。

MD Anderson Cancer Center. What to know about mantle cell lymphoma. Available at: https://www.mdanderson.org/cancerwise/what-to-know-about-mantle-cell-lymphoma-symptoms-diagnosis-and-treatment.h00-159385101.html. Accessed April 2024.

MD安德森癌症中心。关于套细胞淋巴瘤的知识。网址:https://www.mdanderson.org/cancerwise/what-to-know-about-mantle-cell-lymphoma-symptoms-diagnosis-and-treatment.h00-159385101.html.2024年4月访问。

ClinicalTrials.gov. A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL. Available at: https://clinicaltrials.gov/study/NCT02972840. Accessed April 2024.

ClinicalTrials.gov。对先前未经治疗的MCL患者单独使用BR与联合使用阿卡鲁替尼的研究。网址:https://clinicaltrials.gov/study/NCT02972840.2024年4月访问。

Dube S, et al. Continued Increased Risk of COVID-19 Hospitalisation and Death in Immunocompromised Individuals Despite Receipt of ≥4 Vaccine Doses: Updated 2023 Results from INFORM, a Retrospective Health Database Study in England. Poster P0409 at ECCMID 2024

Dube S等人。尽管接受了≥4剂疫苗,但免疫功能低下个体的新型冠状病毒住院和死亡风险持续增加:英格兰回顾性健康数据库研究INFORM的2023年更新结果。ECCMID 2024海报P0409

Wu J, Zhang M, Liu D. Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor. J Hematol Oncol. 2016;9(21).

Wu J,Zhang M,Liu D.Acalabrutinib(ACP-196):一种选择性第二代BTK抑制剂。J Hematol Oncol。2016年;9(21)。

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