AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved in the European Union (EU) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant.

阿斯利康的Calquence（acalabrutinib）联合苯达莫司汀和利妥昔单抗已在欧盟（EU）获批，用于治疗既往未接受过治疗且不符合自体干细胞移植条件的成人套细胞淋巴瘤（MCL）患者。

The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and was based on positive results from ECHO Phase III trial, presented at the European Haematology Association (EHA) 2024 Congress and published in The Journal of Clinical Oncology, which demonstrated that Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy (hazard ratio [HR] 0.73; 95% confidence interval [CI] 0.57-0.94; p=0.016).

欧盟委员会的批准遵循了人用药品委员会的积极意见，基于ECHO III期试验的积极结果。该结果在2024年欧洲血液学协会（EHA）大会上公布，并发表于《临床肿瘤学杂志》，显示与标准治疗的化疗免疫疗法相比，Calquence联合苯达莫司汀和利妥昔单抗可将疾病进展或死亡风险降低27%（风险比[HR] 0.73；95%置信区间[CI] 0.57-0.94；p=0.016）。

Median progression-free survival (PFS) was 66.4 months for patients treated with the Calquence combination versus 49.6 with chemoimmunotherapy alone. The safety and tolerability of Calquence was consistent with its known safety profile, and no new safety signals were identified..

Calquence联合治疗组患者的中位无进展生存期（PFS）为66.4个月，而单独使用化疗免疫疗法的患者为49.6个月。Calquence的安全性和耐受性与其已知的安全性特征一致，未发现新的安全性信号。

MCL is a rare and typically aggressive form of non-Hodgkin lymphoma, often diagnosed at an advanced stage. An estimated 6,000 patients were diagnosed with MCL in the UK, France, Germany, Spain and Italy in 2024.

MCL是一种罕见且通常具有侵袭性的非霍奇金淋巴瘤，常在晚期被诊断出来。据估计，2024年英国、法国、德国、西班牙和意大利有6000名患者被诊断出患有MCL。

Martin Dreyling, MD, Department of Medicine, University Hospital LMU Munich, and investigator in the trial, said: “This approval provides a new first-line treatment option for patients in the EU with mantle cell lymphoma, an aggressive lymphoma with a dismal long-term outcome still today. With a progression-free survival improvement of more than 16 months for these patients, the acalabrutinib combination is a much-needed advance in this challenging disease.”.

马丁·德雷林（Martin Dreyling）博士，慕尼黑大学医院（University Hospital LMU Munich）内科部门，同时也是该试验的研究者，他表示：“此次批准为欧盟的套细胞淋巴瘤患者提供了一种新的首选治疗方案。套细胞淋巴瘤是一种侵袭性淋巴瘤，至今长期预后仍然较差。对于这些患者，阿卡鲁替尼组合疗法使无进展生存期延长了16个月以上，这在这一极具挑战性的疾病中是一项迫切需要的重要进展。”

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “Treatment with the Calquence combination in first-line mantle cell lymphoma demonstrated a significant improvement in progression free survival and a consistent safety profile for patients in the pivotal ECHO trial.

阿斯利康肿瘤血液业务部执行副总裁戴夫·弗雷德里克森表示：“在一线套细胞淋巴瘤中使用Calquence组合治疗，在关键的ECHO试验中显示出了显著改善患者的无进展生存期，并且安全性表现一致。”

As the first and only BTK inhibitor approved in this indication in the EU, we are proud to provide a much-needed new option to patients living with this difficult disease.'.

“作为欧盟首个且唯一获批用于这一适应症的BTK抑制剂，我们很自豪能为患有这一棘手疾病的患者提供一个迫切需要的新选择。”

Calquence plus bendamustine and rituximab is approved in the US and several other countries in this setting based on the ECHO results. Regulatory applications are currently under review in Japan and several other countries in this indication. This approval follows the recent approval for Calquence monotherapy for the treatment of adult patients with relapsed or refractory MCL in the EU. .

基于ECHO试验结果，Calquence联合苯达莫司汀和利妥昔单抗在美国和其他几个国家获批用于该适应症。目前，日本和其他几个国家正在对该适应症的监管申请进行审查。此次批准紧随Calquence单药疗法近期在欧盟获得的批准，用于治疗复发或难治性MCL成年患者。

ECHO is a randomised, double-blind, placebo-controlled, multi-centre Phase III trial

ECHO 是一项随机、双盲、安慰剂对照、多中心的 III 期临床试验。

evaluating the efficacy and safety of Calquence plus bendamustine and rituximab compared to SoC chemoimmunotherapy (bendamustine and rituximab) in adult patients at or over 65 years of age (n=635) with previously untreated MCL. Patients were randomised 1:1 to receive either Calquence or placebo administered orally twice per day, continuously, until disease progression or unacceptable toxicity.

评估Calquence联合苯达莫司汀和利妥昔单抗与标准治疗化疗免疫疗法（苯达莫司汀和利妥昔单抗）在65岁及以上既往未治疗的MCL成人患者（n=635）中的疗效和安全性。患者以1:1的比例随机分配接受Calquence或安慰剂，口服，每日两次，持续治疗直至疾病进展或出现不可接受的毒性。

Additionally, all patients received six 28-day cycles of bendamustine on days 1 and 2 and rituximab on day 1 of each cycle, followed by rituximab maintenance for two years if patients achieved a response after induction therapy..

此外，所有患者均接受了六个28天周期的苯达莫司汀治疗，在每个周期的第1和第2天使用苯达莫司汀，第1天使用利妥昔单抗，随后如果患者在诱导治疗后产生应答，则继续进行两年的利妥昔单抗维持治疗。

The primary endpoint is PFS assessed by an Independent Review Committee; other efficacy endpoints include overall survival (OS), overall response rate, duration of response and time to response. The trial was conducted in 27 countries across North and South America, Europe, Asia and Oceania.

主要终点是由独立审查委员会评估的PFS；其他疗效终点包括总生存期（OS）、总体缓解率、缓解持续时间和达到缓解的时间。该试验在北美、南美、欧洲、亚洲和大洋洲的27个国家进行。

The ECHO trial enrolled patients from May 2017 to March 2023, continuing through the COVID-19 pandemic. Prespecified PFS and OS analyses censoring for COVID-19 deaths were conducted to assess the impact of COVID-19 on the study outcome in alignment with the FDA.

ECHO 试验从 2017 年 5 月至 2023 年 3 月招募患者，贯穿了整个 COVID-19 大流行期间。为评估 COVID-19 对研究结果的影响，并与 FDA 的要求保持一致，预先设定的无进展生存期（PFS）和总生存期（OS）分析对因 COVID-19 导致的死亡进行了删失处理。

Citation:

引用：

Acalabrutinib Plus Bendamustine-Rituximab in Untreated Mantle Cell Lymphoma. Authors: Michael Wang, MD, David Salek, MD, David Belada, MD, Yuqin Song, MD, Wojciech Jurczak, MD, PhD et al. Journal of Clinical Oncology https://doi.org/10.1200/JCO-25-00690

阿卡布鲁替尼联合苯达莫司汀-利妥昔单抗治疗初治套细胞淋巴瘤。作者：Michael Wang，医学博士，David Salek，医学博士，David Belada，医学博士，宋玉琴，医学博士，Wojciech Jurczak，医学博士，哲学博士等。《临床肿瘤学杂志》https://doi.org/10.1200/JCO-25-00690

Condition:

条件：

Mantle Cell Lymphoma

套细胞淋巴瘤

Type:

类型：

drug

药物