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1d
Bruton protein-tyrosine kinase (BTK) FDA-approved small molecule inhibitors used for the management of neoplastic and inflammatory disorders. (PubMed, Pharmacol Res)
Aberrant B cell receptor signaling occurs in several B cell neoplasms including follicular lymphoma (treated with zanubrutinib, a BTK inhibitor), mantle cell lymphoma (acalabrutinib, pirtobrutinib, zanubrutinib), marginal zone lymphoma (zanubrutinib), chronic lymphocytic leukemia and small lymphocytic lymphoma (ibrutinib, acalabrutinib, zanubrutinib, pirtobrutinib), and Waldenström macroglobulinemia (ibrutinib, zanubrutinib)...Pirtobrutinib fails to form a covalent bond and is a reversible BTK inhibitor. The FDA-approvals of rilzabrutinib and remibrutinib (2025) represent the first nononcologic authorizations for BTK antagonists.
FDA event • Review • Journal
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BTK (Bruton Tyrosine Kinase) • PLCG2 (Phospholipase C Gamma 2) • LYN (LYN Proto-Oncogene Src Family Tyrosine Kinase) • SYK (Spleen tyrosine kinase)
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Imbruvica (ibrutinib) • imatinib • cyclophosphamide • Brukinsa (zanubrutinib) • Calquence (acalabrutinib) • vincristine • prednisone • Jaypirca (pirtobrutinib) • Rhapsido (remibrutinib)
14d
AQUALIS:QoL of CLL Patients Treated With Acalabrutinib in France, Retrospective Study Based on Data From PLATON Database (clinicaltrials.gov)
P=N/A, N=120, Recruiting, AstraZeneca | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
Trial completion date • Trial primary completion date • HEOR
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Calquence (acalabrutinib)
19d
Venetoclax Retreatment in Chronic Lymphocytic Leukemia is biologically rational and clinically effective. (PubMed, Blood Adv)
To date, ten abstracts or published manuscripts have reported on venetoclax retreatment, as continuous monotherapy or with FD/MRD guided combinations with anti-CD20 monoclonal antibodies (rituximab, obinutuzumab) or covalent Bruton tyrosine kinase inhibitors (ibrutinib, acalabrutinib). Median progression-free survival, when available, ranged from 23 to 58 months. Optimal patient selection remains to be defined, but the depth of the initial venetoclax response and time to progression from last venetoclax exposure may predict rechallenge efficacy and are incorporated in new clinical trial criteria allowing previous FD venetoclax treatment.
Journal • IO biomarker
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TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2)
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TP53 mutation • TP53 mutation + Chr del(17p)
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Venclexta (venetoclax) • Imbruvica (ibrutinib) • Rituxan (rituximab) • Gazyva (obinutuzumab) • Calquence (acalabrutinib)
22d
Efficacy and safety analysis of BTK inhibitors combined with R-CHOP regimen in newly diagnosed double-expressor diffuse large B-cell lymphoma (PubMed, Zhonghua Xue Ye Xue Za Zhi)
Among them, 35 patients received BTKi (zanubrutinib, orelabrutinib, acalabrutinib) combined with R-CHOP (BTKi + R-CHOP group) , and 60 received R-CHOP regimen alone (R-CHOP group) . Grade ≥ 3 adverse events primarily included neutropenia (28.6% ) and pulmonary infection (14.3% ) ; no fatal bleeding or cardiovascular events occurred. BTKi combined with R-CHOP significantly improved response rates and survival in patients with DE-DLBCL, with manageable safety.
Retrospective data • Journal • IO biomarker
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MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2)
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Rituxan (rituximab) • Brukinsa (zanubrutinib) • Calquence (acalabrutinib) • Inokai (orelabrutinib)
25d
Acalabrutinib and Durvalumab in Primary and Secondary Central Nervous System Lymphoma (clinicaltrials.gov)
P1, N=25, Active, not recruiting, Washington University School of Medicine | Trial completion date: Oct 2027 --> May 2028 | Trial primary completion date: Jan 2026 --> Aug 2026
Trial completion date • Trial primary completion date
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Imfinzi (durvalumab) • Calquence (acalabrutinib)
28d
Acalabrutinib Maintenance for the Treatment of Patients With Large B-cell Lymphoma (clinicaltrials.gov)
P1/2, N=24, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Jan 2027 --> Jan 2028 | Trial primary completion date: Jan 2026 --> Jan 2027
Trial completion date • Trial primary completion date
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BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
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Calquence (acalabrutinib)
1m
The Care and Cure of the Leukemias in 2026. (PubMed, Am J Hematol)
Currently, most leukemias are effectively treated with immunotherapies (highly effective monoclonal antibodies targeting CD19 [blinatumomab], or CD22 [inotuzumab ozogamicin]), BCR::ABL1 tyrosine kinase inhibitors (TKIs; e.g., dasatinib, ponatinib), Bruton TKIs (e.g., ibrutinib, acalabrutinib), BCL-2 inhibitors (venetoclax), IDH1/2 inhibitors (ivosidenib, olutasidenib, and enasidenib), FLT3 inhibitors (e.g., midostaurin, quizartinib, and gilteritinib), menin inhibitors (revumenib, ziftomenib), and chimeric antigen receptor T-cell therapies. Herein, we provide a high-level overview of prominent clinical developments across all leukemias. In contemporary times, harnessing the benefits of novel targeted therapies and the evolving treatment landscape bolster the optimistic view that most, if not all, leukemias are curable.
Review • Journal • IO biomarker
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TP53 (Tumor protein P53) • FLT3 (Fms-related tyrosine kinase 3) • ABL1 (ABL proto-oncogene 1) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • KMT2A (Lysine Methyltransferase 2A) • CD22 (CD22 Molecule)
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TP53 mutation • KMT2A mutation • MLL mutation
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Venclexta (venetoclax) • dasatinib • Imbruvica (ibrutinib) • Iclusig (ponatinib) • Xospata (gilteritinib) • Blincyto (blinatumomab) • midostaurin • Calquence (acalabrutinib) • Vanflyta (quizartinib) • Tibsovo (ivosidenib) • Besponsa (inotuzumab ozogamicin) • Revuforj (revumenib) • Idhifa (enasidenib) • Komzifti (ziftomenib) • Rezlidhia (olutasidenib)
1m
MRD-driven initial therapy of acalabrutinib and lenalidomide plus rituximab or obinutuzumab for mantle cell lymphoma. (PubMed, Blood Adv)
This safe and active regimen is feasible as a time-limited initial therapy for patients with MCL and warrants further evaluation in response-adapted strategy. This trial was registered at www.ClinicalTrials.gov as NCT03863184.
Journal
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TP53 (Tumor protein P53)
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TP53 mutation
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clonoSEQ
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Rituxan (rituximab) • lenalidomide • Gazyva (obinutuzumab) • Calquence (acalabrutinib)
1m
Enrollment open
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Venclexta (venetoclax) • Brukinsa (zanubrutinib) • Calquence (acalabrutinib) • sonrotoclax (BGB-11417)
1m
Enrollment open
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Calquence (acalabrutinib)
2ms
Acalabrutinib in CNSL (clinicaltrials.gov)
P1/2, N=49, Active, not recruiting, Dana-Farber Cancer Institute | Recruiting --> Active, not recruiting
Enrollment closed
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Calquence (acalabrutinib)
2ms
Calquence CLL 1L Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study (clinicaltrials.gov)
P=N/A, N=67, Completed, AstraZeneca | Trial completion date: May 2026 --> Aug 2025 | Trial primary completion date: May 2026 --> Aug 2025 | Active, not recruiting --> Completed
Trial completion • Trial completion date • Trial primary completion date
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Calquence (acalabrutinib)