RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Priority Review (United States)

Structure/Sequence

Molecular FormulaC26H23N7O2

InChIKeyWDENQIQQYWYTPO-IBGZPJMESA-N

CAS Registry1420477-60-6

167

Clinical Trials associated with Acalabrutinib

NCT07582159

/ Not yet recruitingPhase 2IIT

A Phase 2 Study of Acalabrutinib, Venetoclax and Tafasitamab (AVT) in Patients With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

This phase II trial tests the safety, side effects and how well giving tafasitamab with acalabrutinib and venetoclax works for the treatment of chronic lymphocytic leukemia (CLL)/small cell lymphoma (SLL). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Tafasitamab is a monoclonal antibody that binds to CD19 antigen which is found on the surface of most B cells (a type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. 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 such as mantle cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving tafasitamab with acalabrutinib and venetoclax may be safe and effective for treating patients with CLL/SLL.

Start Date19 Dec 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT07024706

/ RecruitingPhase 2

The MAVRiC Study: A Phase II Study of Disease Risk Mutation Guided Finite Duration Acalabrutinib Plus Venetoclax for Relapse in CLL/SLL After First-line Finite Covalent BTKi Plus BCL2i Combination, With or Without Obinutuzumab

This study will evaluate the efficacy and safety of finite-duration acalabrutinib plus venetoclax therapy in patients with relapsed CLL or SLL, and have previously responded to first line (1L) cBTKi + BCL2i therapy (± obinutuzumab) and maintained a response for at least two years post-treatment.

Start Date04 Jun 2026

Sponsor / Collaborator

AstraZeneca PLC

[+2]

NCT07635511

/ Not yet recruitingPhase 3IIT

Acalabrutinib Maleate Monotherapy or in Combination With Bortezomib for Eliminating HLA Antibodies in Patients With Hematologic Malignancies and Platelet Transfusion Refractoriness: a Multicenter, Randomized Controlled Study

Platelet transfusion refractoriness (PTR) is a common complication in patients with hematological malignancies. It not only prolongs the duration of platelet transfusion dependence and significantly increases the risk of bleeding, but is also strongly associated with graft failure and reduced survival after transplantation. HLA class I antibody-mediated alloimmunization is recognized as the most important immunological cause of PTR. HLA antibodies are directly secreted by plasma cells, which are derived from B cells. Therefore, targeting B cells to reduce antibody production is a crucial step in eliminating HLA antibodies. Bruton's tyrosine kinase (BTK) is expressed throughout B cell development from the pre-B cell stage to maturity and supports B cell development, maturation, survival, proliferation, and antibody production by acting as a downstream kinase in the B cell receptor signaling pathway. Bortezomib, a proteasome inhibitor, can selectively induce apoptosis in long-lived plasma cells. The investigators' preliminary exploratory use of a BTK inhibitor in the treatment of PTR with HLA antibodies significantly reduced the mean fluorescence intensity (MFI) of HLA antibodies, improved platelet transfusion outcomes, and demonstrated a favorable safety profile. Based on these findings, the investigators are conducting a prospective, multicenter, randomized controlled two-arm study to investigate the efficacy and safety of acalabrutinib and bortezomib in eliminating HLA antibodies in hematological malignancies patients with PTR.

Start Date01 Jun 2026

Sponsor / Collaborator

The First Affiliated Hospital of Soochow University

100 Clinical Results associated with Acalabrutinib

100 Translational Medicine associated with Acalabrutinib

100 Patents (Medical) associated with Acalabrutinib

821

Literatures (Medical) associated with Acalabrutinib

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Prolonged progression-free survival with zanubrutinib in relapsed/refractory CLL: an indirect treatment comparison versus other BTK inhibitors using multilevel network meta-regression

Article

Author: Xu, Sheng ; Yang, Keri ; Bouwmeester, Walter ; Mohseninejad, Leyla ; Shadman, Mazyar ; Jevdjevic, Milica ; Jansen, Jeroen P. ; Williams, Rhys

BACKGROUND:

Bruton tyrosine kinase inhibitors (BTKis) are therapeutic agents for relapsed/refractory chronic lymphocytic leukemia (R/R CLL). Previous indirect treatment comparisons are limited in simultaneously comparing multiple interventions and adjusting for population differences. This study aimed to use a more rigorous approach called multilevel network meta-regression (ML-NMR) to estimate the relative treatment effects of zanubrutinib compared to acalabrutinib and ibrutinib in two target populations: a general R/R CLL population similar to the phase 3 ALPINE trial's intention-to-treat (ITT) population, and a high-risk population with del(17p) and/or del(11q), similar to the ITT population of the phase 3 ELEVATE-RR trial.

METHODS:

The ML-NMR was conducted using data from three phase 3 randomized controlled trials: ALPINE (N = 652), ELEVATE-RR (N = 533), and ASCEND (N = 310). Progression-free survival (PFS) and overall survival (OS) were the outcomes of interest. The ML-NMR integrated individual patient data from ALPINE with aggregate data from the other trials, incorporating important effect modifiers to estimate relative treatment effects for the target populations.

RESULTS:

In the general R/R CLL population, zanubrutinib showed an improved PFS compared to ibrutinib (HR = 0.67, 95% Credible Interval [CrI] = 0.52-0.87) and acalabrutinib (HR = 0.57, 95% CrI = 0.34-0.95). In the high-risk population, zanubrutinib maintained its PFS advantage over ibrutinib and acalabrutinib. OS was similar across BTKis in both populations, with wide CrIs that included an estimate of no difference between treatments.

CONCLUSION:

This ML-NMR suggests that zanubrutinib offers improved PFS compared to ibrutinib and acalabrutinib in both general and high-risk R/R CLL populations. OS results were uncertain due to limited follow-up.

23 Jun 2026·Blood Advances

Invasive fungal infections after Bruton tyrosine kinase inhibitor treatment: a systematic review and meta-analysis

Review

Author: Kates, Olivia S. ; Avery, Robin K. ; Srisurapanont, Karan ; Dioverti-Prono, M. Veronica ; Zhang, Sean X. ; Permpalung, Nitipong ; Baddley, John W. ; Meejun, Tanaporn ; Schulz, Cory A. ; Li, Lucy X. ; Manothummetha, Kasama

Abstract:

The epidemiology of invasive fungal infections (IFIs) among patients receiving Bruton tyrosine kinase inhibitors (BTKIs) remains incompletely characterized. We conducted a systematic review and meta-analysis of 88 studies including 23 737 patients to evaluate the prevalence and risk factors for IFIs in this population. Among 16 studies that applied the European Organization for Research and Treatment of Cancer and the Mycoses Study Group Education and Research Consortium consensus definitions of IFIs, the pooled prevalence of proven/probable IFIs was 2.83% (95% confidence interval [CI], 1.97-4.06), with the highest prevalence observed in patients with central nervous system lymphoma (9.02%). Aspergillosis was the most frequently reported IFI (1.76%), followed by pneumocystosis, candidiasis, and cryptococcosis. The risk factors significantly associated with proven/probable IFIs were concurrent corticosteroid use (odds ratio [OR], 5.03; 95% CI, 2.31-10.92) and ≥3 previous lines of therapy (OR, 3.26; 95% CI, 1.54-6.88). Across clinical trials, the prevalence of fungal infections varied across BTKI agents, ranging from 2.50% with tirabrutinib, to 0.62% with pirtobrutinib. Data on antifungal and Pneumocystis jirovecii pneumonia prophylaxis were limited and inconclusive. Among clinical trials that reported fungal infections as adverse events, the prevalence of IFI was the highest in patients treated with tirabrutinib (2.50%), followed by zanubrutinib (2.13%), ibrutinib (1.75%), acalabrutinib (1.31%), orelabrutinib (1.08%), and pirtobrutinib (0.62%). Although some findings suggest a potential benefit in selected patients, current evidence remains insufficient to support broad prophylaxis recommendations. These results underscore the need for individualized risk assessment and further research to inform prevention strategies.

13 Jun 2026·EXPERT OPINION ON PHARMACOTHERAPY

From covalent to reversible: the expanding role of BTK inhibitors in chronic lymphocytic leukemia

Review

Author: Robak, Tadeusz

INTRODUCTION:

BTK inhibitors are divided into two groups based on their binding mechanism: covalent, irreversible (cBTKis), and non-covalent, reversible BTK inhibitors (ncBTKis). The covalent BTK inhibitors approved for use in CLL include the first-generation inhibitor ibutinib and second-generation BTK inhibitors, acalabrutinib and zanubrutinib. Non-covalent and reversible BTKs bind reversibly to BTK and remain effective even if C481S mutations are present.

AREAS COVERED:

This paper reviews recent developments in the use of BTK inhibitors in the treatment of chronic lymphocytic leukemia (CLL). Google Scholar and PubMed were initially searched for articles in English, published from 2016 to Aril 2026. In addition, a manual search was performed of conference proceedings from the last 5 years of The American Society of Hematology, American Society of Clinical Oncology and the European Hematology Association.

EXPERT OPINION:

Covalent BTKis and ncBTKis revolutionized CLL treatment in the last decade Three cBTKis, ibrutinib, acalabrutinib, and zanubrutinib, are approved by FDA for the treatment of CLL. The most advanced ncBTKis are pirtobrutinib and nemtabrutinib. Of these, only pirtobrutinib is recommended for patients refractory to cBTKis. However, further clinical trials focusing on dose optimization are needed, as well as combination studies with existing drugs and novel agents.

293

News (Medical) associated with Acalabrutinib

29 Jun 2026

·www.fiercepharma.com

BeOne’s Brukinsa hits goal in mantle cell lymphoma confirmatory trial

A Brukinsa regimen has delivered a large progression-free survival (PFS) benefit in what BeOne Medicines called a “new chemotherapy-free standard” in first-line mantle cell lymphoma. The BTK inhibitor, combined with rituximab, reduced the risk of progression or death by 43% compared with bendamustine and rituximab (BR) in the phase 3 Mangrove study, BeOne announced Tuesday. Overall survival (OS), a key secondary endpoint, remained immature but showed a “strong trend” in favor of the Brukinsa regimen, the company said. The Mangrove study, also known as BGB-3111-306, is meant to serve as the confirmatory trial for Brukinsa’s accelerated approval in previously treated MCL. Granted in 2019, that FDA nod kicked off Brukinsa’s blockbuster journey. BeOne said it’s in discussions with regulatory authorities on planned submissions in 2026. OS outcomes will likely be key in BeOne’s approval bid with the FDA. Previously, AbbVie and Johnson & Johnson withdrew Imbruvica’s MCL indication in the U.S. after the phase 3 Shine study showed a statistically significant reduction in the risk of disease progression or death, but a negative OS trend, for the addition of Imbruvica to bendamustine and rituximab. In early 2025, the FDA greenlighted AstraZeneca’s rival BTK drug Calquence, used in tandem with bendamustine and rituximab, in first-line MCL patients who are ineligible for autologous stem cell transplant. In the phase 3 Echo study, the Calquence regimen cut the risk of disease progression or death by 27% versus bendamustine and rituximab. At the time of the PFS analysis, OS data remained immature but favored the Calquence regimen, with patient deaths reported in 32% of the Calquence arm versus 35% in the control arm. Then, in July 2025, based on the phase 3 Triangle study conducted in Europe, J&J convinced the European Commission to approve Imbruvica as part of a multi-drug combination, which involves the R-CHOP combo, for first-line MCL patients who would be eligible for an autologous stem cell transplant. In that study, Imbruvica plus chemoimmunotherapy with or without transplant significantly reduced the risk of death by 47.8% versus transplant and chemoimmunotherapy. Now, without bendamustine and rituximab maintenance, Brukinsa plus rituximab has shown “unprecedented improvements” in PFS, “potentially redefining the treatment paradigm globally,” BeOne’s chief medical officer of hematology, Amit Agarwal, M.D., Ph.D., said in a June 30 statement. “We believe it would be very meaningful for patients to be free from the burden of frequent infusions,” he added. Sparing patients the toxicity burden of upfront chemotherapy could be beneficial in MCL, as the non-Hodgkin lymphoma subtype predominantly affects older adults, according to BeOne. An approval in first-line MCL could help Brukinsa pull further ahead of Calquence in revenue as the two drugs eat away at Imbruvica’s market share. In the first quarter, Brukinsa global sales reached $1.1 billion, versus $923 million for Calquence.

Clinical ResultPhase 3Drug ApprovalImmunotherapyAccelerated Approval

15 Jun 2026

·allsci.com

Lilly’s Jaypirca on course to reshape post-BTKi CLL treatment after beating venetoclax

Eli Lilly’s pirtobrutinib (Jaypirca) became the first therapy to outperform a venetoclax-based regimen in a Phase III study for chronic CLL study. As presented by Lilly via a late-breaking oral presentation at the 2026 European Hematology Association (EHA) Annual Meeting, pirtobrutinib added to a time-limited venetoclax-based regimen in relapsed or refractory chronic lymphocytic leukemia/ small lymphocytic leukemia (CLL/SLL) reduced the risk of progression or death by 45%, potentially establishing a new second-line option for patients previously treated with covalent BTK inhibitors. The presentation represented a full data rundown following the release of topline data in April. The BRUIN CLL-322 trial enrolled 639 previously treated patients, 79.8% of whom had prior covalent BTK inhibitor exposure — a deliberate design choice that mirrors how CLL is now managed in practice. Patients were randomized to pirtobrutinib plus AbbVie/Genentech’s Venclexta (venetoclax) and rituximab (PVR) or venetoclax and rituximab alone (VR). At a median follow-up of 27.3 months, median PFS in the PVR arm was not reached versus 39.7 months in the VR arm (HR\=0.55 [95% CI, 0.40–0.75]; p\=0.0001). The benefit was consistent across high-risk subgroups including those with TP53 mutation or deletion, unmutated IGHV, and complex karyotype. In an exploratory analysis of second-line patients whose disease progressed after a first-line covalent BTKi, the hazard ratio was 0.32 (95% CI, 0.14–0.73), with 24-month PFS rates of 88% versus 52%. The safety profile showed limited additive toxicity. Grade ≥3 adverse events occurred in 78.8% of the PVR arm versus 73.0% with VR alone, and treatment discontinuation rates were nearly identical (5.4% versus 5.1%). Notably, pirtobrutinib’s three-cycle lead-in before venetoclax introduction downgraded tumor lysis syndrome risk in a substantial proportion of patients — 78% of those classified as high-risk were moved to medium or low risk — a clinically meaningful finding given the complexity of venetoclax ramp-up. Overall survival data remain immature. Competitive context Pirtobrutinib is a non-covalent, reversible BTK inhibitor, mechanistically distinct from covalent agents such as BeiGene’s Brukinsa (zanubrutinib) and AstraZeneca/Acerta’s Calquence (acalabrutinib). Its key differentiator is retained activity against the BTK C481S resistance mutation that commonly drives progression on covalent BTKi therapy. The drug already holds US FDA approval as monotherapy for CLL/SLL patients who have received a prior covalent BTKi. BRUIN CLL-322 now positions it as a potential combination partner in the second-line setting, a meaningfully different commercial and clinical proposition. Cross-trial comparisons are limited, but the venetoclax plus rituximab control arm in BRUIN CLL-322 — with a median PFS approaching 40 months — performed comparably to historical benchmarks from the MURANO trial, lending credibility to the trial’s internal comparison. The result also has implications for treatment architecture in CLL more broadly. As Lilly noted in its presentation, many patients in the modern era receive only two lines of therapy, making the depth and durability of second-line treatment increasingly consequential. A regimen that combines the resistance-overcoming mechanism of pirtobrutinib with the time-limited, treatment-free interval of venetoclax-based therapy addresses both the efficacy and quality-of-life dimensions that now shape prescribing decisions. Lilly plans to submit BRUIN CLL-322 data to global regulatory authorities to expand Jaypirca’s label, with the data presented as a late-breaking oral at the 2026 European Hematology Association Annual Meeting. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Clinical ResultPhase 3ASH

11 Jun 2026

·www.biospace.com

BioInvent’s BI-1206 Triplet Achieves 83% Response Rate in Refractory NHL with Improved Safety vs. SOC (EHA 2026)

BioInvent will host an in-person KOL lunch briefing (11:45 a.m. - 2:00 p.m. CEST / 5:45 - 8:00 a.m. EDT) in conjunction with EHA 2026 Congress today (virtual event link here ) 83% ORR across all evaluable patients in the total non-Hodgkin's lymphoma (NHL) population (n=23) 81% objective response rate (ORR) and 44% complete response rate (CRR) in relapsed/refractory follicular lymphoma (FL), on par with the recently approved tafasitamab+R2 (rituximab + Revlimid) combination Markedly lower rate of serious adverse events (14%) versus tafasitamab+R2 (34%), obinutuzumab+zanubrutinib (35%), rituximab+lenalidomide "R2" (29-32%), and epcoritamab+R2 (56%) Only 3% TEAE (treatment emergent adverse events)-related treatment discontinuation, compared to 7%-19% across R2-based standard-of-care regimens Acalabrutinib (Calquence ® ) with BI-1206 + rituximab boosted efficacy without increasing toxicity LUND, SE / ACCESS Newswire / June 11, 2026 / BioInvent International AB ("BioInvent") (Nasdaq Stockholm:BINV), a leader in the discovery of novel immune-modulatory antibodies, today announced new clinical data from the BI-1206 triplet combination in relapsed/refractory (R/R) non-Hodgkin's lymphoma (NHL) to be presented in a poster at the 31 st European Hematology Association (EHA2026) Congress, taking place June 11-14, 2026 in Stockholm, Sweden. The poster summarizes key efficacy, safety, and mechanistic data from the ongoing Phase 1/2 study ( NCT03571568 ) evaluating BI-1206 in combination with rituximab and Calquence ® (acalabrutinib) in patients with relapsed or refractory NHL, including follicular lymphoma. BI-1206 directly targets FcγRIIB-mediated rituximab internalization, a major driver of resistance to CD20-directed therapy, while leveraging BTK inhibition with acalabrutinib to enhance anti-tumor activity. "These EHA data reinforce our conviction that BI-1206 has the potential to meaningfully change the treatment landscape for patients with relapsed or refractory follicular lymphoma," said Martin Welschof, Chief Executive Officer of BioInvent. "An 81% response rate that matches or exceeds recently approved combinations - coupled with a safety pro is markedly more favorable than the widely used R2-based regimens - is exactly the kind of differentiated clinical pro set out to build. BI-1206 is now the cornerstone of our NHL strategy, and we look forward to advancing this program toward pivotal development as we work to bring a compelling new option to patients who urgently need it." Overview of data included in the poster at EHA 2026 The BI-1206 triplet exhibits an ORR and safety pro with established clinical benchmarks, including standard-of-care (SOC) R2 therapy and the recently approved tafasitamab+R2 combination, underscoring its potential as a highly competitive therapeutic option in R/R FL. As of data cut-off May 6, 2026, the triplet of BI-1206 + rituximab + acalabrutinib delivered an 83% objective response rate (ORR) in the total population (n=23 evaluable), with 11 complete responses (CR) and 8 partial responses (PR). In the follicular lymphoma (FL) subset (n=16), ORR was 81% and complete response rate (CRR) was 44%. All remaining patients exhibited stable disease as best response, giving a disease control rate (DCR) of 100%. The cohort has been completely enrolled, though response assessment has not yet occurred for all patients; as the majority of patients are still on treatment, any PFS (progression-free survival) calculation is yet premature. The regimen showed a very favorable tolerability profile, with treatment-related serious adverse events observed in only 4 (14%) patients and discontinuation due to a drug-related adverse event in 1 patient. Grade 3+ treatment-related adverse events observed in only 31% of patients, versus 54-84% for comparator regimens. Poster presentation details Title: Targeting resistance to rituximab through FcγRIIB (CD32B) blockade: BI-1206 + rituximab + acalabrutinib shows powerful activity in R/R NHL Presenter: Dr. Laura Fogliatto, Hospital de Clínicas de Porto Alegre, Brazil Session Date/Time: Friday, June 12, 6:45 pm-7:45 pm CEST (12:45 pm-1:45 pm EDT) Location: EHA2026 Congress, Stockholm The poster will be posted to the Scientific Publications section of the company website ( ) when the presentation has occurred. About the BI-1206 Phase 2a part of the study The triple combination arm in the ongoing Phase 2a part of the study (NCT03571568) combines the subcutaneous formulation of BI-1206 with rituximab and acalabrutinib in subjects with indolent B-cell non-Hodgkin's lymphoma (NHL) who have relapsed or are refractory to rituximab. Patient enrolment (approximately 30 patients) has been completed in Spain, Germany, USA, and Brazil. BioInvent has a clinical supply agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) providing Calquence ® (acalabrutinib) for the combination arm. About BI-1206 FcγRIIB is overexpressed in several forms of NHL and its overexpression has been associated with poor prognosis in difficult-to-treat subtypes, including mantle cell lymphoma. FcγRIIB-mediated internalization of rituximab is a well-established driver of resistance to CD20-directed therapy. By blocking this receptor on tumor cells, BI-1206 is designed to restore and enhance rituximab activity in combination regimens. The clinical rationale for the BI-1206 triplet is supported by the ROSEWOOD trial (Zinzani et al., JCO 2023), which showed that adding the BTK inhibitor zanubrutinib to the Fc-engineered anti-CD20 antibody obinutuzumab - which has reduced but not absent FcγRIIB-mediated internalization - increased ORR from 45% to 69% and median PFS from 10.4 to 28 months in R/R FL. By contrast, acalabrutinib added to standard rituximab yielded only 31% ORR and a median PFS of 8.3 months (Strati et al., Br J Haem 2024), despite similar BTK kinase profiles for the two inhibitors. These data point to improved CD20 targeting - not BTK inhibition per se - as the key driver of superior outcomes. Because BI-1206 directly targets FcγRIIB-mediated internalization, combining it with rituximab and acalabrutinib offers a mechanistically distinct approach to overcoming rituximab resistance. The 81% ORR observed in the EHA 2026 data, substantially exceeding the 31% seen with acalabrutinib plus rituximab alone, is consistent with this hypothesis. BI-1206 is evaluated in two separate clinical Phase 1/2a programs, one for the treatment of solid tumors and one for the treatment of non-Hodgkin's lymphoma (NHL), a type of blood cancer. Both programs show encouraging clinical activity along with good tolerability. About BioInvent BioInvent 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 drug candidates in 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 . For further information, please contact: Cecilia Hofvander, VP Investor Relations Phone: +46 (0)46 286 85 50 Email: cecilia.hofvander@bioinvent.com BioInvent International AB (publ) Co. Reg. No.: 556537-7263 Visiting address: Ideongatan 1 Mailing address: 223 70 LUND Phone: +46 (0)46 286 85 50 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. Attachments BioInvent’s BI-1206 Triplet Achieves 83% Response Rate in Refractory NHL with Improved Safety vs. SOC (EHA 2026) SOURCE: BioInvent International View the original press release on ACCESS Newswire

Clinical ResultPhase 2Drug ApprovalImmunotherapyPhase 1

100 Deals associated with Acalabrutinib

External Link

KEGG	Wiki	ATC	Drug Bank
D10893	Acalabrutinib	L01XE51	DB11703

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Mantle cell lymphoma recurrent	European Union	AstraZeneca AB	27 May 2025
Mantle cell lymphoma recurrent	Iceland	AstraZeneca AB	27 May 2025
Mantle cell lymphoma recurrent	Liechtenstein	AstraZeneca AB	27 May 2025
Mantle cell lymphoma recurrent	Norway	AstraZeneca AB	27 May 2025
Mantle cell lymphoma refractory	European Union	AstraZeneca AB	27 May 2025
Mantle cell lymphoma refractory	Iceland	AstraZeneca AB	27 May 2025
Mantle cell lymphoma refractory	Liechtenstein	AstraZeneca AB	27 May 2025
Mantle cell lymphoma refractory	Norway	AstraZeneca AB	27 May 2025
Small Lymphocytic Lymphoma	United States	AstraZeneca UK Ltd.	21 Nov 2019
Chronic Lymphocytic Leukemia	Canada	AstraZeneca Canada, Inc.	02 Oct 2019
Mantle-Cell Lymphoma	United States	AstraZeneca UK Ltd.	31 Oct 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
ALK positive large B-cell lymphoma	Phase 3	Germany	AstraZeneca PLC	07 Jun 2023
Large B-cell lymphoma	Phase 3	Germany	AstraZeneca PLC	07 Jun 2023
Mediastinal large B-cell lymphoma	Phase 3	Germany	AstraZeneca PLC	07 Jun 2023
Recurrent Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type	Phase 3	Germany	AstraZeneca PLC	07 Jun 2023
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Germany	AstraZeneca PLC	07 Jun 2023
Recurrent Chronic Lymphoid Leukemia	Phase 3	Germany	AstraZeneca PLC	19 Apr 2022
Diffuse Large B-Cell Lymphoma	Phase 3	United States	AstraZeneca PLC	08 Oct 2020
Diffuse Large B-Cell Lymphoma	Phase 3	China	AstraZeneca PLC	08 Oct 2020
Diffuse Large B-Cell Lymphoma	Phase 3	Japan	AstraZeneca PLC	08 Oct 2020
Diffuse Large B-Cell Lymphoma	Phase 3	Australia	AstraZeneca PLC	08 Oct 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04257578 (2129, CTgov)	Phase 1/2	High grade B-cell lymphoma \| Follicular Lymphoma \| Mediastinal large B-cell lymphoma	23	Axicabtagene Ciloleucel+Acalabrutinib (Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-negative Cohort)	hosrrzpzjd = kkjvrliypl rskcsrakas (jivkxrayeu, voeahqoqli - sbqutusoaf) View more	-	25 Jun 2026
				Axicabtagene Ciloleucel+Acalabrutinib (Treatment (Acalabrutinib, Axicabtagene Ciloleucel) - HIV-positive Cohort)	lnuglaklqw(lsubowwpbw) = latgyfydnn jzxfqlmect (mjglxkyuov, mfyfjyyxwj - wxpopfnrnr) View more
NCT04548648 (LCCC1841, CTgov)	Phase 2	Recurrent Central Nervous System Lymphoma \| Primary Central Nervous System Lymphoma	10	Acalabrutinib	qzlndiutya = vevcfzoksg rmlssapqqb (qqgpkzcwlc, scikmteuck - gpozizzclo) View more	-	10 Jun 2026
NCT02029443 (Pubmed \| Blood Adv)	Phase 1/2	Chronic Lymphocytic Leukemia	233	Acalabrutinib (treatment-naive)	iaodcypeou(zsnkesizpe) = 6.1% and 9.0% prevuvmpou (xqiwkthnbd ) View more	Positive	09 Jun 2026
				Acalabrutinib (relapsed/refractory)
ASCO2026	Not Applicable	Chronic Lymphocytic Leukemia First line	10,523	Zanubrutinib	nqawimfswz(cprfhcoobp) = yugfuyyans wspmfkdhre (zfrkrqgwzl ) View more	Positive	29 May 2026
				Ibrutinib	nqawimfswz(cprfhcoobp) = unkdgdmfyg wspmfkdhre (zfrkrqgwzl ) View more
ASCO2026	Phase 2/3	Chronic Lymphocytic Leukemia First line	3,056	Venetoclax plus ibrutinib	awmlqobhsq(kifkwyxofm): HR = 0.52 (95.0% CI, 0.41 - 0.67)	Positive	29 May 2026
				Acalabrutinib plus obinutuzumab
ASCO2026	Not Applicable	Chronic Lymphocytic Leukemia	233,362	zanubrutinib	xykkisttgt(ioxiiluqhb) = bdqnpanyeo wcpyhkedzd (eiofbumsfu ) View more	Positive	29 May 2026
				Acalabrutinib	xykkisttgt(ioxiiluqhb) = zfwakuzais wcpyhkedzd (eiofbumsfu ) View more
EHA2026	Not Applicable	Chronic Lymphocytic Leukemia First line	243	Acalabrutinib (Treatment-naïve)	yrlvheiojn(dgwczunyti) = klabqrmzoy mroxoogmlv (zlnnqpdfgw ) View more	Positive	12 May 2026
				Acalabrutinib (Relapse/refractory)	yrlvheiojn(dgwczunyti) = xatcqusluq mroxoogmlv (zlnnqpdfgw ) View more
EHA2026	Not Applicable	Chronic Lymphocytic Leukemia First line	3,370	Ibrutinib	lghgajskmf(biowhuxhsm) = jdmpqrwdmk mduahkfmiw (bojlffgmhw ) View more	Positive	12 May 2026
				Acalabrutinib	lghgajskmf(biowhuxhsm) = xgpmfolqmz mduahkfmiw (bojlffgmhw ) View more
NCT04008706 (ASSURE, EHA2026)	Phase 3	Chronic Lymphocytic Leukemia del(17p) \| mutated TP53 \| unmutated IGHV	552	Acalabrutinib 100 mg	uosiarkydm(vtnxoerawy) = hikmforyif rtqwcqajbt (oivgjxxwdl ) View more	Positive	12 May 2026
				Acalabrutinib 100 mg (TN)	uosiarkydm(vtnxoerawy) = ijqtdrbkrg rtqwcqajbt (oivgjxxwdl ) View more
EHA2026	Not Applicable	Mantle-Cell Lymphoma First line	22	BendamustineiBKT (Acalabrutinib for mNHL, Zanubrutinib for MNHL)Rituximabine + BendamustineiBKT (Acalabrutinib for mNHL, Zanubrutinib for MNHL)Rituximab + BendamustineiBKT (Acalabrutinib for mNHL, Zanubrutinib for MNHL)Rituximablabrutinib for mNHL, Zanubrutinib for MNHL)	omdxilainf(erpblnwzsc) = no patients experienced CMV reactivation (from retrospective data from our center, approximately 25% of patients treated with R-Benda had developed CMV reactivation) mnwkplaczj (mvaxlaigml ) View more	Positive	12 May 2026

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