People who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) are often treated with ibrutinib, acalabrutinib, or zanubrutinib. These are pills that are taken by mouth. This type of pill is called "Bruton Tyrosine Kinase Inhibitor" or BTKi. Another treatment for CLL/SLL is a different pill called venetoclax.
The purpose of this study is to compare continuing the current treatment with BTKi alone, as long as it is working, to another arm of treatment which adds venetoclax to the current treatment (BTKi), for one year. After one year, both pills in this arm of treatment would be stopped and the participants will be closely monitored.

开始日期2025-04-01

申办/合作机构

VA Office of Research and Development

NCT06757647

/ Not yet recruiting临床2期IIT

Prospective Phase 2 Study of the Effect of Acalabrutinib on Myocardium on Ibrutinib Exposed Patients with CLL

This phase II trial tests how well acalabrutinib works in treating patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and evaluates how treatment with acalabrutinib affects heart function. Acalabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. CLL/SLL patients treated with a different BTK inhibitor called ibrutinib often experience cardiac side effects, leading to discontinuation of life-saving therapy. Treatment with acalabrutinib after discontinuing, or even before starting, treatment with ibrutinib may reverse or prevent cardiac side effects and be an effective treatment option for patients with CLL/SLL.

开始日期2025-03-01

申办/合作机构

Ohio State University Comprehensive Cancer Center

[+2]

NCT06651970

/ Not yet recruiting临床4期

A Multicentre, Open-label, Randomised Phase IV Study to Investigate Acalabrutinib Monotherapy Compared to Investigator's Choice of Treatment in Adults (> 18 Years) With Chronic Lymphocytic Leukaemia and Moderate to Severe Cardiac Impairment

This will be a global Phase IV, open-label, randomised study to evaluate the safety and tolerability of acalabrutinib (monotherapy, 100 mg orally [po], twice daily [bd]) compared to investigator's choice of treatment, in patients with CLL (TN or R/R) and moderate to severe cardiac impairment. All patients will have cardiac impairment as defined by LVEF of < 50%.
Randomisation will be stratified by LVEF > 40% vs ≤ 40% to stratify for moderate and severe cardiac impairment, which for this study are defined as follows:
Severe cardiac impairment: in those with LVEF ≤ 40% Moderate cardiac impairment: in those with LVEF > 40% to < 50%. The study is planned to take place in approximately 20 centres globally. The study will be conducted in centres that have established close collaboration between the Haematology and Cardiology divisions, preferably with a cardio-oncologist on the team.
An IDMC will be responsible for making recommendations for study continuation.

开始日期2024-12-31

申办/合作机构

AstraZeneca PLC

[+3]

100 项与阿可替尼相关的临床结果

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100 项与阿可替尼相关的转化医学

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100 项与阿可替尼相关的专利（医药）

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507

项与阿可替尼相关的文献（医药）

2025-01-03·Cancer diagnosis & prognosis

Complete Response (CR) in a Previously-progressing Chronic Lymphocytic Leukemia (CLL) Patient Treated With Methionine Restriction in Combination With First-line Chemotherapy

Article

作者: Han, Qinghong ; Hoffman, Robert M ; Tsuchiya, Hiroyuki ; Demura, Satoru ; Miwa, Shinji ; Kimura, Hiroaki ; Morinaga, Sei ; Kang, Byung Mo ; Higuchi, Takashi ; Mizuta, Kohei ; Igarashi, Kentaro ; Hayashi, Katsuhiro ; Yamamoto, Norio

Background/Aim: Chronic lymphocytic leukemia (CLL) is currently incurable. CLL is characterized by disordered DNA methylation. The aim of the present study was to target methylation with methionine restriction in a patient with progressive CLL. Case Report: Methionine restriction for the patient was achieved with a low-methionine vegan diet and oral recombinant methioninase (o-rMETase). The patient also received rituximab, once per week for four weeks, and acalabrutinib 100 mg, twice daily (bid) continuously. The patient’s white blood cell count decreased by 95% from peak levels and extensive lymphadenopathy disappeared during combination treatment with o-rMETase, rituximab, and acalabrutinib. Conclusion: The combination of methionine restriction and first-line chemotherapy resulted in an apparent complete response (CR) in a CLL patient, a rare event. The duration of the CR will be monitored, and additional CLL patients will be treated similarly in the future.

2025-01-01·BMJ Case Reports

Cerebral aspergillosis in a patient with chronic lymphocytic leukaemia complicated by Evans syndrome

Article

作者: Amer, Aly ; Elyas, Mortada

This case report presents a complex medical scenario involving early 60s female patient with a history of chronic lymphocytic leukaemia (CLL) complicated by Evans syndrome, characterised by autoimmune haemolytic anaemia and immune thrombocytopenia. The patient had received various treatments, including steroids, rituximab, cyclosporine and acalabrutinib. The patient’s neurological symptoms began around 3 years prior to presentation, with shaking of her right leg, followed by shaking of both hands, particularly the left hand. She experienced shaking during activities and at rest. Additional symptoms included voice changes, numbness in the feet, dizziness, faintness, fatigue, nausea, vomiting, headaches, walking difficulty, speech changes and back pain. Neurological examination revealed resting tremors, bradykinesia, rigidity and infrequent blinking. An MRI of the brain revealed a 28 mm enhancing intra-axial lesion in the right frontal parietal lobe, accompanied by a 7 mm nodule in the left parietal lobe, both suggestive of neoplastic aetiology. A surgical resection was performed, identifying septate branching fungal hyphae consistent with Aspergillus species, leading to the diagnosis of cerebral aspergillosis. Voriconazole was initiated and subsequently adjusted based on therapeutic drug levels. The patient’s treatment course was complicated by declining platelets, diagnosed as thrombocytopenia, and a positive COVID-19 test result. She received rituximab, immunoglobulin therapy and antifungal treatment adjustments. The patient’s clinical condition improved, including a reduction in tremors and regained mobility. This case underscores the challenges of managing a patient with CLL-associated immune complications, cerebral aspergillosis and a dynamic treatment plan. Clinicians must consider individualised therapeutic strategies and monitor for treatment-related complications in complex cases like this one

2025-01-01·HEMATOLOGICAL ONCOLOGY

Molecular Profiling Identifies CD49d and CD79b as Predictive Markers for Acquired Acalabrutinib Resistance in Patients With Chronic Lymphocytic Leukemia

Article

作者: Byrd, John C. ; Mortlock, Andrew ; De Jesus, Gary ; Yamaguchi, Kyoko ; Covey, Todd ; Do, Phuong ; Brown, Jennifer R. ; Parsa, Sara ; Dougherty, Brian ; Clevenger, Tracy ; Munugalavadla, Veerendra ; Hartmann, Tanja N. ; Whitston, David ; Burke, Kathleen ; Floren, Muskan ; Bibikova, Elena ; Furman, Richard R. ; Gulrajani, Michael ; Cheung, Jean ; Frigault, Melanie M. ; Law, Brian ; Brock, Graham

ABSTRACT:

Contemporary studies of Bruton tyrosine kinase inhibitor (BTKi) resistance focus on mutations in the B‐cell receptor (BCR) pathway, but alternative mechanisms of resistance remain undefined. Here, we sought to identify novel predictive markers of acquired resistance to acalabrutinib, a second‐generation BTKi, in patients with chronic lymphocytic leukemia (CLL). Clinical samples from 41 patients with relapsed/refractory or treatment‐naive CLL receiving acalabrutinib as part of a clinical trial (NCT02029443) were divided into two groups: those who continued to respond to treatment (NP, n = 23) and those who developed progressive disease on acalabrutinib therapy (PD, n = 18). Peripheral blood mononuclear cells (PBMCs) from the two groups of patients were profiled at baseline (BL) and at a second timepoint (T2) by RNA‐seq and flow cytometry. Our findings show a correlation between acquired resistance to acalabrutinib and upregulation of integrin alpha‐4 (ITGA4; CD49d), the BCR surface receptor CD79B, and oncogenes such as MYC, LAG3, and MCL1 in CLL cells. High surface expression of CD49d and CD79b prior to acalabrutinib therapy was associated with increased risk of disease progression on acalabrutinib in patients with CLL. When stratified by pretreatment CD49d surface expression, the CD49dhi group (defined as ≥ 30% CD49d+ cells at baseline) showed reduced acalabrutinib‐induced lymphocytosis and higher levels of tumor proliferation markers such as CD38 and Ki‐67 compared with the CD49dlo group (defined as < 30% CD49d+ cells at baseline). In summary, CD49d and CD79b are useful predictive markers for CLL progression on acalabrutinib.Trial Registration:ClinicalTrials.gov identifier: NCT02029443

537

项与阿可替尼相关的新闻（医药）

2025-01-09

·ioncology

ASH看世界丨David John Lewis教授：套细胞淋巴瘤领域无化疗时代即将到来？

编者按 2024年第66届美国血液学会（ASH）年会现已圆满落下帷幕。本次盛会汇聚了来自全球各地的三万余名专家学者，通过百余场精心策划的专题会议，为血液疾病的基础研究、创新治疗、疾病管理等多个维度带来了诸多宝贵的洞见与深刻的启迪。为了深入剖析ASH年会的精髓，把握血液学领域的最新动态，《肿瘤瞭望-血液时讯》特此邀请英国普利茅斯大学医院NHS信托基金会David John Lewis教授，为我们分享其在套细胞淋巴瘤领域的独到见解与研究心得。此外，《肿瘤瞭望-血液时讯》还精心编译了ASH官方发布的关于滤泡性淋巴瘤与套细胞淋巴瘤领域的突破性进展，旨在为广大读者呈现相关领域的前沿动态与重大发现。 David John Lewis教授：我是一名来自英国普利茅斯的血液学顾问，主要的临床与研究兴趣集中在淋巴瘤领域。我就职于一个开展大量早期及首次人体临床试验，以及大型随机研究的中心。我是在 ASH上展示的 ENRICH 研究的首席研究员，同时也是今年同样在 ASH 上展示的 OASIS2 研究的英国联合首席研究员。此外，我还在一家大型移植中心及 CAR - T 中心工作。在本次ASH年会上，我重点展示了ENRICH研究的最新数据。这是一项具有里程碑意义的大型III期随机研究的初步分析，旨在深入对比伊布替尼-利妥昔单抗联合用药方案与化疗方案在初治套细胞淋巴瘤患者中的实际疗效。令人振奋的是，我们的研究首次揭示了在这类患者中，非化疗方法相较于传统化疗具有显著优势，特别是在无进展生存期方面，伊布替尼-利妥昔单抗联合用药展现出了更为卓越的表现。本次会议中套细胞淋巴瘤的进展无疑反映了BTK抑制剂正逐步向一线治疗领域迈进的趋势。并且，我认为我们即将迎来套细胞淋巴瘤的无化疗治疗方案时代。从我展示的ENRICH研究数据中，我们可以清晰地看到伊布替尼-利妥昔单抗联合用药相较于化疗的显著优势。同时，Steven Le Gouill所展示的OASIS2中期分析结果也为我们提供了宝贵的参考，该研究对比了一种三药联合的非化疗方案（伊布替尼、维奈克拉加CD20单克隆抗体）与伊布替尼和CD20单克隆抗体联用方案的疗效。这些研究成果无疑激发了研究者们对无化疗方案临床试验的极大热情，也让我们有理由相信，将套细胞淋巴瘤的无化疗方案作为标准一线治疗方法指日可待。所以，就套细胞淋巴瘤领域而言，正如我之前所言，我们正在逐步设定新的治疗标准。然而，面对未来，我们仍需正视一个严峻的挑战：在高危母细胞样患者的治疗中，我们目前的努力还远远不够。因此，我们迫切需要针对这些高危患者开发新的疗法，并开展新的临床试验。我认为，现有的治疗方案对这些患者而言并不尽如人意，我们必须寻求突破。此外，另一个需要我们重点关注的问题是，当一线BTK抑制剂成为套细胞淋巴瘤患者的标准治疗方案后，我们该如何规划后续的第二、三线治疗？这将是未来我们需要深入探索的重要方向。（上下滑动查看英文原文） Dr. David John Lewis：I'm a hematology consultant from Plymouth in the United Kingdom. My main clinical and research interest is lymphoma. I work in a center that conducts a large number of early-phase and first-in-human clinical trials, as well as large randomized studies. I'm the chief investigator on the ENRICH study, which was presented at ASH, and I'm also the joint UK chief investigator on the OASIS2 study, which is also presented at ASH this year. I also work in a major transplant center and a CAR-T center. I presented the ENRICH data, which was the primary analysis of a large phase III randomized study comparing a lbrutinib-Rituximab with chemotherapy in previously untreated mantle cell lymphoma patients. And we were the first study in history to show an advantage for a non-chemotherapy approach over chemotherapy in this group of patients, with an advantage for progression-free survival of lbrutinib-Rituximab over chemotherapy. I think the focus on mantle cell lymphoma at this conference reflects the movement of BTK inhibitors further forward to first-line treatment. And I think we're on the cusp of looking at chemotherapy-free regimens for mantle cell lymphoma. We saw the ENRICH data that I presented, showing the advantage of lbrutinib-Rituximab over chemotherapy. We also saw the OASIS2 interim analysis presented by Steven Le Gouill, which actually compares a three-drug non-chemotherapy triplet（lbrutinib, Venetoclax Plus CD20 Monoclonal Ab） with lbrutinib and CD20 Monoclonal Ab.So we can see a huge amount of enthusiasm for these clinical trials of chemotherapy-free regimens. It does feel now that it's only a matter of time before we have a chemotherapy-free regimen for mantle cell lymphoma as a standard first-line treatment. So, regarding mantle cell lymphoma, I think, as I said, we're setting a new standard of care. I think in terms of future questions, what's clear is that we're really not doing very well with very high-risk blastoid patients. So we really need new treatments and new clinical trials targeted at these very high-risk patients, because I think we're currently failing them with our current treatment regimens. And the other major thing that we're going to need to look at is when we're giving everyone a first-line BTK inhibitor, what do we do then? Second, third line? 时讯传真滤泡性淋巴瘤与套细胞淋巴瘤治疗中的选择困境及其超越策略（作者：Andrés Gómez-De León 与 Michelle Morcos-Sandino）研究与技术的进步对于改善患者护理及治疗效果至关重要。然而，伴随这些进步，新的挑战也应运而生，尤其在针对像套细胞淋巴瘤（MCL）这类复杂疾病的决策制定方面。如今，对于初诊的 MCL 患者，我们拥有一系列可纳入免疫化疗方案的治疗选择，如蛋白酶体抑制剂、免疫调节剂以及布鲁顿酪氨酸激酶（BTK）抑制剂等。每新增一个选择，治疗方案选择的复杂性便随之增加。对于日常诊治淋巴瘤患者的临床医生而言，这些选择伴随着不确定性，仿若一棵遥不可及的参天大树。幸运的是，在ASH中关于惰性 B 细胞淋巴瘤的口头摘要会议上，围绕 MCL 和滤泡性淋巴瘤（FL）治疗的复杂性得以揭开神秘面纱。本次会议的一大亮点将是欧洲学术 MCL 网络开展的 TRIANGLE 随机 III 期试验的新篇章，该试验旨在探究一线伊布替尼联合免疫化疗的疗效。继ASH2022全体会议报告及发表之后，关于自体移植巩固治疗的作用，我们仍心存悬念。该研究的主要作者Martin Dreyling博士，将通过回答两个悬而未决的问题续写后续篇章：接受伊布替尼联合免疫化疗但未进行移植的患者，与标准治疗方案相比，其长期预后如何？移植对含伊布替尼的治疗组有何额外益处？“这些数据确凿可靠，”Dreyling博士称，“经过中位五年的随访，如今我们将给出确切答案”（摘要240）。在 TRIANGLE 试验的另一方面，Marco Ladetto博士展示了利妥昔单抗维持治疗作用的回顾性分析，揭示其对试验各治疗组安全性与有效性的潜在影响（摘要 237）。口头摘要中还涵盖了各类探索 MCL 不同强度治疗的试验结果。Nina D. Wagner-Johnston博士展示了ECOG - ACRIN EA4181 研究结果，该研究考察了阿卡替尼联合苯达莫司汀 - 利妥昔单抗及阿糖胞苷 - 利妥昔单抗的疗效（摘要 236）。此外，David John Lewis博士讨论了ENRICH 随机 III 期试验结果，该试验对比了伊布替尼联合利妥昔单抗与利妥昔单抗无化疗方案在老年患者中的疗效（摘要 235）。“这项研究为 MCL 未来试验中的标准对照治疗组下了定义，” Lewis博士说道，“我认为听众会对研究结果感到惊讶。” 诸多因素会影响并塑造共同决策过程。患者的偏好与目标是什么？我们如何在追求新奇以及 “全口服非化疗” 的吸引力之间找到平衡，须知后者未必是更佳选择。临床医生必须协助患者权衡对毒性的恐惧、长期风险、短期获益以及潜在的利弊权衡，同时还要让患者对所给出的建议充满信心。这种细致入微的决策方法在 FL 治疗中尤为关键，因为治疗方案会依据疾病负担而有所不同。对于疾病负担极小的患者，“观察等待” 策略被认为是可行的。然而，不作为同样可能带来危害，因为患者可能会因焦虑而影响生活质量，这也使得该策略在私下被戏称为 “观察担忧”。 Noriko Fukuhara博士则展示了 JOCG1411/Flora 研究结果（摘要 338），该研究以随机方式探究了早期给予利妥昔单抗单药治疗对低肿瘤负荷 FL 患者的疗效，旨在确定早期免疫治疗能否延缓疾病进展，进而减少细胞毒性化疗的需求。在 FL 一线治疗上融入更多现代元素，并引领即将到来的双特异性抗体浪潮，Lorenzo Falchi博士在会议上展示了 Mithic - FL1 II 期试验的初步分析结果（摘要 340），该试验将 CD20xCD3 双特异性抗体莫妥珠单抗用于具有治疗指征的 FL 患者。还有更多关于复发难治性疾病新型疗法的口头摘要呈现，包括对 loncastuximab tesirine、epocoritamab 以及尚未命名的双特异性抗体和嵌合抗原受体 T 细胞（CAR - T）疗法的分析。在这些会议结束之际，MCL 和 FL 治疗中的 “选择悖论”被揭开神秘面纱，呈现出更清晰、更具可操作性的策略，为血液科医生提供为患者提供最高水平治疗所需的关键见解。（来源：《肿瘤瞭望–血液时讯》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

细胞疗法免疫疗法临床3期引进/卖出ASH会议

2025-01-08

·医药魔方Info

首仿！齐鲁制药「伊布替尼片」仿制药获批

1月8日，国家药监局官网显示，齐鲁制药的伊布替尼片仿制药获批。这是国内首款获批的伊布替尼片剂仿制药。原研伊布替尼（Imbruvica，中文商品名：亿珂）是强生与艾伯维合作开发的一款BTK抑制剂，也是全球首个获批上市的BTK抑制剂。已上市的伊布替尼包括片剂、胶囊剂和混悬剂三种剂型。2013年11月，伊布替尼胶囊获得FDA批准上市，规格包括70mg和140mg。2018年2月，伊布替尼片剂在美国获批，规格包括140mg、280mg、420mg和560mg。2022年8月，伊布替尼口服混悬剂（70mg/mL）也在美国获批。截至目前，伊布替尼在美国共获批了6项适应症，覆盖套细胞淋巴瘤（MCL）、慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）、华氏巨球蛋白血症（WM）和慢性移植物抗宿主病（cGVHD）四类疾病。伊布替尼是血液瘤领域的划时代产品，其巅峰时期销售额接近百亿美元。在其之后，全球又有多款同靶点药物上市，包括阿可替尼（阿斯利康）、tirabrutinib（吉利德）、泽布替尼（百济神州）、奥布替尼（诺诚健华）和匹妥布替尼（礼来）。根据中国上市药品专利信息登记网站的记录，伊布替尼的中国化合物专利将在2026年12月28日到期。先声药业已率先出击，其伊布替尼胶囊在2022年10月获国家药监局批准，拿下伊布替尼胶囊首仿资格。此外，Natco Pharma和海步医药/亚宝生物的伊布替尼胶囊也在2024年获得了国家药监局的批准许可。除此之外，国内还有多家药企布局了伊布替尼仿制药，例如双鹭药业、华东医药、南京正大天晴等公司。不过，仅湖南科伦制药和齐鲁制药布局了伊布替尼片剂仿制药。 Copyright © 2025 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

专利到期专利无效上市批准

2025-01-08

·bioinvent.com

BioInvent announces promising initial efficacy data from triple combination arm of BI-1206, rituximab and Calquence for the treatment of non-Hodgkin's lymphoma

The first two patients enrolled in the Phase 2a study triplet arm combining BI-1206 with rituximab and Calquence® responded to treatment One complete response (CR) and one partial response (PR) The treatment has been well-tolerated with no safety or tolerability concerns Study now expanding to additional clinical investigational sites and patient enrollment on track with further Phase 2a results expected by mid-2025 One complete response (CR) and one partial response (PR) The treatment has been well-tolerated with no safety or tolerability concerns Lund, Sweden – January 8, 2025 – BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announces promising initial clinical response data from the two enrolled patients in the triple combination arm of the Phase 1/2a study of its anti-FcyRIIB antibody, BI-1206, combined with rituximab and AstraZeneca’s Bruton’s tyrosine kinase (BTK) inhibitor Calquence® (acalabrutinib), in non-Hodgkin's lymphoma (NHL). The preliminary data demonstrates that the combination treatment is well tolerated with the two enrolled patients already showing clinical responses. One patient has obtained a complete response (CR), and one patient shows a partial response (PR). Patient enrollment remains on schedule. Further Phase 2a data are expected by mid-2025. The triplet arm in the Phase 2a study is combining the subcutaneous formulation of BI-1206 and rituximab with Calquence® (acalabrutinib). Approximately 30 patients are expected to be enrolled in Spain, Germany, the US, and Brazil. In February 2024 BioInvent signed a clinical supply agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to provide Calquence® for the combination arm. "It is highly encouraging to see that the move to subcutaneous administration of BI-1206 has led to the improved safety profile we had predicted and hoped for, while also continuing to deliver on the promising efficacy signals already observed. We are also very pleased with the initial data from the Phase 2a triple combination study showing that the first two patients enrolled at the lower dose in the safety run-in are showing responses”. said Martin Welschof, Chief Executive Officer of BioInvent. “The treatment is so far well-tolerated and with increasing interest in the study driven by the triplet arm, we are confident that we can remain on track with enrollment and provide further data next year.” In addition, the Phase 1/2a study of BI-1206 in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in heavily pre-treated patients with solid tumors continues to progress. The subcutaneous administration of BI-1206 has been well-tolerated with no notable injection reactions. Given the beneficial safety and tolerability profile observed to date, an additional dose cohort with increased dose frequency has been added to the Phase 1 part to further characterize the dose-response/safety of BI-1206 SC in order to maximize the likelihood of success in the subsequent Phase 2a part of the study. The complete response (CR) in solid tumors previously reported in May 2024 at this year's ASCO Annual Meeting for a patient with metastatic melanoma is nearing the two-year milestone, with the response maintained. "With BI-1206, we are continuing to produce compelling clinical data in both non-Hodgkin's lymphoma and solid tumors that demonstrate the potential of targeting FcyRIIB to restore the activity of existing cancer treatments which could lead to life-transforming therapies for patients," said Martin Welschof, Chief Executive Officer of BioInvent. "We look forward to further data from both studies next year and continue to believe that BI-1206 can play an important part in future treatment options for patients with different types of cancers." Calquence® is a registered trademark of the AstraZeneca group of companies. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About BI-1206BI-1206 is one of BioInvent's lead drug candidates and is developed to re-establish the clinical effect of existing cancer treatments such as pembrolizumab and rituximab. The drug candidate is evaluated in two separate clinical programs, one for the treatment of non-Hodgkin's lymphoma (NHL, a type of blood cancer) and one for the treatment of solid tumors. BI-1206 in NHLAll patients in the ongoing Phase 1/2a study (NCT03571568) have previously been treated with one or more rituximab containing treatments. Latest results for the combination of BI-1206 and rituximab were presented in connection with EHA (European Hematology Association) congress in June 2024: the intravenous (IV) Phase 1 part (dose escalation) showcased responses across the dose range of 30-100 mg, including 5 patients with complete response (CR), 1 with partial response (PR) and 6 patients with stable disease (SD) out of 17 evaluable patients. Data from the subcutaneous (SC) Phase 1 part (dose escalation) with BI-1206 + rituximab has showed 2 CR, 3 PR and 3 SD out of 9 evaluable patients. In February 2024 BioInvent signed a clinical supply agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to provide Calquence® for the triple combination arm of BI-1206 + rituximab + Calquence®. BI-1206 in solid tumorsClinical Phase 1/2a study with BI-1206 in combination with pembrolizumab (NCT04219254) ongoing. In May 2024, the company announced promising Phase 1 data for BI-1206 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in heavily pre-treated patients with solid tumors. The data showed encouraging and durable responses in patients who previously had failed on anti-PD-1/L1 therapy. The combination was well-tolerated in this heavily pre-treated population of patients. Out of 28 evaluable patients (as of Oct 14th, 2024), the results included one complete response (CR) in metastatic melanoma, one partial response (PR) in uveal melanoma and eight patients with stable disease (SD) as best response, whereof one long-lasting metastatic melanoma patient who had previously progressed on nivolumab treatment that remained a stable disease throughout the two-year study duration. The ongoing study is recruiting patients with advanced solid tumors who had progressed on prior treatments including PD-1/PD-L1 immune checkpoint inhibitors. Patients receive a three-week cycle of BI-1206 in combination with pembrolizumab for up to two years, or until disease progression. About BioInventBioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently five drug candidates in six ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at www.bioinvent.com. Follow us on the social media platform X: @BioInvent. For further information, please contact:Cecilia Hofvander, VP Investor RelationsPhone: +46 (0)46 286 85 50Email: cecilia.hofvander@bioinvent.comBioInvent International AB (publ)Co. Reg. No. Org nr: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 50www.bioinvent.com The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.

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KEGG	Wiki	ATC	Drug Bank
D10893	阿可替尼	L01XE51	DB11703

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适应症	国家/地区	公司	日期
小淋巴细胞淋巴瘤	美国	AstraZeneca UK Ltd.	2019-11-21
慢性淋巴细胞白血病	加拿大	AstraZeneca Canada, Inc.	2019-10-02
套细胞淋巴瘤	美国	AstraZeneca UK Ltd.	2017-10-31

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适应症	最高研发状态	国家/地区	公司	日期
大B细胞淋巴瘤	临床3期	德国	AstraZeneca PLC	2023-06-07
复发性慢性淋巴细胞白血病	临床3期	德国	AstraZeneca PLC	2022-04-19
弥漫性大B细胞淋巴瘤	临床3期	美国	AstraZeneca PLC	2020-10-08
弥漫性大B细胞淋巴瘤	临床3期	中国	AstraZeneca PLC	2020-10-08
弥漫性大B细胞淋巴瘤	临床3期	日本	AstraZeneca PLC	2020-10-08
弥漫性大B细胞淋巴瘤	临床3期	澳大利亚	AstraZeneca PLC	2020-10-08
弥漫性大B细胞淋巴瘤	临床3期	奥地利	AstraZeneca PLC	2020-10-08
弥漫性大B细胞淋巴瘤	临床3期	比利时	AstraZeneca PLC	2020-10-08
弥漫性大B细胞淋巴瘤	临床3期	巴西	AstraZeneca PLC	2020-10-08
弥漫性大B细胞淋巴瘤	临床3期	加拿大	AstraZeneca PLC	2020-10-08

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03571568 (Company_Website) 人工标引	临床2期	非霍奇金淋巴瘤	2	BI-1206 + rituximab + Calquence	艱鑰簾鏇鹹觸鹹顧蓋遞(蓋觸窪遞觸淵淵簾範顧) = 製憲蓋選壓廠憲選鬱鏇膚鏇窪構淵積範觸觸衊 (壓襯夢獵膚憲鹽襯艱獵 ) 更多	积极	2025-01-08
NCT04462328 (ASH2024) 人工标引	临床1期	原发性中枢神经系统淋巴瘤	13	Acalabrutinib 100 mg BID + DurvalumabDurvalumab 1500 mg IV	蓋鹽製鑰遞廠糧壓簾鬱(選齋膚衊蓋窪遞鹹窪餘) = 窪觸鑰醖構範積簾蓋鬱壓顧廠繭鑰積製糧遞餘 (膚鹽淵餘積蓋鏇蓋選窪 ) 更多	积极	2024-12-09
NCT03836261 (AMPLIFY, ASH2024) 人工标引	临床3期	慢性淋巴细胞白血病一线	867	Acalabrutinib + Venetoclax	糧繭夢願糧遞糧鑰餘艱(鬱餘觸遞觸鬱顧製願構) = 觸構觸願願齋選窪憲網構壓膚窪衊艱顧憲衊廠 (範鏇遞襯糧鹹壓構鏇糧 ) 更多	积极	2024-12-09
				Acalabrutinib + Venetoclax + Obinutuzumab	糧繭夢願糧遞糧鑰餘艱(鬱餘觸遞觸鬱顧製願構) = 簾鏇繭壓鏇蓋觸夢範鹹構壓膚窪衊艱顧憲衊廠 (範鏇遞襯糧鹹壓構鏇糧 ) 更多
ASH2024	N/A	套细胞淋巴瘤	-	Acalabrutinib 100 mg BID + Rituximab 375 mg/m2 IV	膚鏇顧憲醖襯鏇範廠衊(顧製壓衊膚膚糧憲選壓) = grade 3-4 AE were cardiovascular toxicity in 7 pts 選淵鹹膚繭壓獵鹹膚鹹 (夢夢鬱艱蓋鹹觸簾構願 ) 更多	-	2024-12-09
ASH2024	N/A	套细胞淋巴瘤	-	Acalabrutinib	襯衊膚範衊鹽餘製鹹衊(鬱衊襯壓選齋鏇觸膚觸) = 16% 醖鹹構繭夢願膚憲醖積 (顧遞簾鬱廠製製餘鏇觸 ) 更多	-	2024-12-09
				Venetoclax
ASH2024	N/A	慢性淋巴细胞白血病	-	Acalabrutinib 100 mg	鹹齋糧壓觸獵餘願廠廠(選獵構積蓋醖憲淵積構) = AEs leading to death occurred in 1 pt in the acalabrutinib arm (unrelated to study drug) 構鬱遞艱鏇廠選願憲襯 (衊鏇鬱鑰築壓蓋簾製積 ) 更多	-	2024-12-08
				Chlorambucil+Rituximab
ASH2024	N/A	弥漫性大B细胞淋巴瘤	-	RICE-A + Acalabrutinib 100mg BID	範憲獵艱淵鹹顧築選廠(願觸蓋鹹艱齋齋廠遞衊) = Gastrointestinal AEs were observed in 5 patients (4 Grade1/2 and 1 Grade3/4) 淵網製壓夢窪襯顧網廠 (鏇鑰鑰繭獵淵艱憲網鏇 ) 更多	-	2024-12-08
ASH2024	N/A	慢性淋巴细胞白血病	-	Ibrutinib 420 mg/day	願襯鏇鏇簾廠艱獵築齋(窪襯築築夢顧壓膚積醖) = 21% for acala 繭壓淵網鑰蓋製餘範鹽 (範憲憲艱艱遞願壓顧夢 ) 更多	-	2024-12-08
				Acalabrutinib 100 mg twice daily
ASH2024	N/A	套细胞淋巴瘤	-	Acalabrutinib (BR/CR)	範淵齋鑰構積簾選顧遞(觸蓋膚鬱構選鑰構廠鬱) = 鹹壓衊憲願願願鬱窪構範鹽範遞糧淵鑰選積淵 (構築衊齋積齋願構製鑰 ) 更多	-	2024-12-07
				Acalabrutinib (BR/CR-A)	範淵齋鑰構積簾選顧遞(觸蓋膚鬱構選鑰構廠鬱) = 選憲範簾窪壓窪鏇願獵範鹽範遞糧淵鑰選積淵 (構築衊齋積齋願構製鑰 ) 更多
ASH2024	N/A	慢性淋巴细胞白血病	-	Acalabrutinib	鹽選顧鏇製願憲夢齋簾(艱遞廠獵醖獵積積範鏇) = 構衊獵憲築鹹憲選選顧顧襯鬱鬱製窪簾廠遞觸 (鑰夢網廠衊憲範觸淵憲 ) 更多	-	2024-12-07
				Obinutuzumab	糧構艱憲餘艱憲憲觸蓋(願夢廠糧憲餘餘憲製餘) = 艱範艱獵顧餘廠夢窪窪願選鬱鹽糧鬱鹹窪網蓋 (艱夢餘簾繭夢鑰齋繭鹹 ) 更多