Zanubrutinib aspen study ASPEN was a Phase 3, randomized, open-label, Study of zanubrutinib (BGB For AEs of special interest for BTK inhibitors, atrial fibrillation/flutter of any grade was 2. Abbreviations: BID, twice Zanubrutinib continues to demonstrate meaningful efficacy and favorable safety in patients with WM. 3 months (range, 5. Patients with MYD88 MUT were randomized to Based on long-term follow-up from the phase Ⅰ/Ⅱ AU-003 study, zanubrutinib resulted in overall survival rates of 96% at 24 months and 91% at 36 months (Cull (2020). Post-hoc acalabrutinib or zanubrutinib in their respective pooled safety analyses, the study population in the pooled safety analysis of zanubrutinib monotherapy included a higher proportion of patients The phase III ASPEN study demonstrated the comparable efficacy and improved safety of zanubrutinib versus ibrutinib in patients with Waldenström macroglobulinemia (WM). The safety and efficacy of zanu monotherapy (160 mg twice daily or 320 mg once daily) Biomarker analysis of the ASPEN study comparing zanubrutinib with ibrutinib for patients with Waldenström macroglobulinemia. Up to 20% of the overall population. Off-target effects Methods: This study is an ongoing US, phase 2, multicenter, single-arm, open-label study. Figure 1. This • As of June 23, 2023, 40 patients (85%) remained on study treatment; the median zanubrutinib treatment duration was 15. The study compared 327 patients taking zanubrutinib with 325 taking ibrutinib; results published in last year in the New England Journal of Medicine showed a hazard ratio The ASPEN study’s phase III trial initially demonstrated the comparable efficacy and enhanced safety profile of zanubrutinib compared to ibrutinib in patients with Waldenström ASPEN consisted of 2 cohorts: patients with MYD88 mutations and those without. 1), and the overall. 11-13 Compared with ibrutinib, zanubrutinib has Biomarker analysis of the ASPEN study comparing zanubrutinib with ibrutinib for patients with Waldenström macroglobulinemia Constantine S. The phase 3 ASPEN study compared the efficacy and This ongoing, phase 2, multicentre, open-label, single-arm study was done in 20 centres in the USA. , November 05, 2024--BeiGene, Ltd. Zanubrutinib's Superior Tolerability: The ASPEN study demonstrated that zanubrutinib had better tolerability compared to ibrutinib, a standard treatment for ASPEN Study Objectives. Off Study Treatment. In a multinational, phase 3, randomized trial, we performed a head-to-head comparison of zanubrutinib with ibrutinib as treatment for relapsed or refractory CLL or small lymphocytic lymphoma The phase 3 ASPEN study compared the efficacy and safety of ibrutinib, a first-generation BTK inhibitor, with zanubrutinib, a novel highly selective BTK inhibitor, in patients with WM. The ASPEN study: Phase III Clinical Trial of Zanubrutinib versus Ibrutinib (Median follow-up of 19. Materials & methods: The ASPEN study consisted of a randomized comparison of zanubrutinib and ibrutinib efficacy and safety in patients with WM who have the MYD88 mutation, as well as a separate cohort of Introduction: BTK inhibitors (BTKi) have become a standard of care for WM. Tolerability in these trials, however, in which Clinical Outcomes in Patients with Waldenström Macroglobulinemia Receiving Ibrutinib on the Phase 3 ASPEN Study ≥1 Year After Transitioning to Zanubrutinib 3043 Poster Zanubrutinib in patients with previously treated B-cell malignancies intolerant of previous Bruton tyrosine Analyses included all patients who received any dose of the study drug. ASPEN: Results of a The phase 3 ASPEN trial (NCT03053440) compared Bruton tyrosine kinase inhibitors (BTKis), zanubrutinib and ibrutinib, in patients with Waldenström macroglobulinemia (WM). , Discovery of zanubrutinib (BGB-3111), a novel, potent, and selective covalent inhibitor of Bruton’s tyrosine kinase. / Tam, Constantine S; Opat, Stephen; D'Sa, Shirley P et al. While both drugs were highly Context: ASPEN is a randomized, open-label, phase 3 study comparing zanubrutinib, a potent and selective Bruton tyrosine kinase inhibitor (BTKi), with the first Zanubrutinib is a next-generation BTK inhibitor with minimal off-target effects, Described here is a head-to-head Phase III study comparing the efficacy and safety of zanubrutinib with those of Infections were the most common TEAE leading to death (total pooled zanubrutinib, 3. Last update: 12/3/2021 iwmf. ASPEN Cohort 1 Study Objectives. The ASPEN trial is an open-label, multicenter, phase 3 study in patients with WM requiring treatment. @article{Tam2024BiomarkerAO, title={Biomarker analysis of the ASPEN study comparing zanubrutinib with ibrutinib for patients with Waldenstr{\"o}m macroglobulinemia}, Study design and treatment. Primary Objective • To compare the efficacy of zanubrutinib vs ibrutinib – Primary endpoint was CR + VGPR rate in patients with activating mutations Zanubrutinib. Blood. Treated. Blood 136 (2020): 2038 . median treatment The phase III randomized ASPEN study evaluated 102 patients on zanubrutinib versus 99 on ibrutinib (Cohort 1) and 28 patients without MYD88 mutations on zanubrutinib needed to study the potential use of zanubrutinib in this setting. The ALPINE (A Study of Zanubrutinib [BGB-3111] Versus Ibrutinib Study design and treatments BGB-3111-302 (ASPEN) is a randomized open-label phase 3 study comparing ibrutinib and zanubrutinib in patients with WM who required treatment based on Zanubrutinib, a highly selective BTK inhibitor, is approved for patients with MCL who have received ≥1 prior therapy. Patients. participation in parent studies of zanubrutinib for treatment of B-cell malignancies • Here, we report safety and efficacy outcomes, with extended follow-up from LTE1, in patients with WM • ASPEN (Study BGB-3111-302) compared BRUKINSA with ibrutinib in 229 patients with WM. The ASPEN study (BGB-3111-302; NCT03053440) directly compared outcomes of treatment with It was designed to achieve maximal exposure while minimizing inhibition of off-target kinases, such as epidermal growth factor receptor, interleukin–2-inducible kinase, and Zanubrutinib Fact Sheet . Log in with Facebook Log in with Google. A randomized We compared zanubrutinib with bendamustine–rituximab to determine its effectiveness as frontline therapy in patients with CLL or SLL. Keywords: National Institutes of Health; National Center fo The phase III ASPEN study demonstrated the comparable efficacy and improved safety of zanubrutinib versus ibrutinib in patients with Waldenström macroglobulinemia (WM). This ongoing, phase 2, multicentre, open-label, single-arm study was done in 20 centres in the USA. We report the long-term safety and efficacy results from Explore the BRUKINSA® (zanubrutinib) study design page featuring the head-to-head Waldenström's Macroglobulinemia (WM) trial, ASPEN. BGB-3111 AU-003 (NCT02343120) is a first-in-human, multicenter, phase 1/2 study of zanubrutinib in patients with B-cell malignancies at 24 sites in 6 ASPEN Study Design: Zanubrutinib vs Ibrutinib in MYD88 MUT WM 6 a Up to 20% of the overall population. . , A The ASPEN study is an ongoing phase III, randomized, open-label, (MAIC) was conducted based on a systematic literature review that compared the individual patient data of Zanubrutinib treatment was associated with a trend toward better response quality and less toxicity, particularly cardiovascular toxicity, which demonstrate that zanubRutinIB and ibrut inib A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenström macroglobulinemia: the ASPEN study. Zanubrutinib is a next-generation BTK inhibitor Waldenström macroglobulinemia (WM), an incurable B-cell malignancy, is sensitive to Bruton tyrosine kinase (BTK) inhibition with ibrutinib, a first-generation BTK inhibitor. Table 2. PURPOSEThe combination of zanubrutinib plus obinutuzumab (ZO) was found to be Aim ASPEN is a randomized, open-label, Phase III study comparing zanubrutinib and ibrutinib in patients with Waldenström macroglobulinemia (WM). 0% in the zanubrutinib arm and 15. Cohort 1 is a randomized (1:1) comparison of ibrutinib and zanubrutinib in In the head-to-head ASPEN trial of zanubrutinib vs ibrutinib in patients with Waldenström macroglobulinemia (WM), zanubrutinib showed a lower rate of AEs leading to Bruton tyrosine kinase (BTK) inhibition is an effective treatment approach for patients with Waldenström macroglobulinemia (WM). ASPEN Study Design: Zanubrutinib vs Ibrutinib in . Table 1. It was designed to achieve maximal exposure while minimizing inhibition of off-target kinases, such as epidermal growth factor receptor, interleukin–2-inducible kinase, and Src family Bruton tyrosine kinase inhibitors (BTKi) are effective treatments for patients with Waldenström macroglobulinemia (WM) []. 2%; ASPEN/ALPINE ibrutinib, 6. Sa S, et al. trial of zanubrutinib vs ibrutinib in symptomatic Waldenstrom macroglobulinemia: the ASPEN study. Dimopoulos MA, et al. Patients aged 18 or older with previously treated B-cell malignancies The phase III ASPEN study demonstrated the comparable efficacy and improved safety of zanubrutinib versus ibrutinib in patients with Waldenström macroglobulinemia (WM). 4 months) 1. Email. Patients aged 18 or older with previously treated B-cell malignancies Zanubrutinib (BGB-3111) is a highly specific next-generation BTK inhibitor with favorable oral bioavailability, as shown in preclinical studies. n=20 (7 PD, 4 AE, 5 Pt Decision, 2 Inv ASPEN is an open-label, multicenter, randomized phase 3 study of zanubrutinib vs ibrutinib in patients with WM (Figure 1) Figure 1: ASPEN Study Design: Zanubrutinib vs Ibrutinib in ASPEN Study: Long-Term Clinical In this same study, zanubrutinib did decrease systemic exposure to drugs metabolized by CYP3A, but there was no impact seen in its concomitant use with proton pump • ASPEN (NCT03053440) is an ongoing open-label, multicenter, randomized, phase 3 study designed to assess the safety, efficacy, and clinical benefit of zanubrutinib versus ibrutinib in Introduction: BTK inhibitors (BTKi) have become a standard of care for WM. 3% in the ibrutinib arm; minor bleeding was 48. Primary Objective • Compare the efficacy of zanubrutinib vs ibrutinib – Primary endpoint was Context: ASPEN is a randomized, open-label, phase 3 study comparing zanubrutinib, a potent and selective Bruton tyrosine kinase inhibitor (BTKi), with the first-generation BTKi, ibrutinib, in Zanubrutinib is a covalent Bruton tyrosine kinase inhibitor that has been approved for adult patients with Waldenström Macroglobulinemia (WM) by the European Medical The phase 3 ASPEN study compared the efficacy and safety of ibrutinib, a first-generation BTK inhibitor, with zanubrutinib, a novel, highly selective BTK inhibitor, in patients The former was the first-in-human, dose-escalation study of zanubrutinib in various B-cell malignancies, One of them, the ASPEN study (NCT03053440) in patients with WM, ASPEN Study Design: Zanubrutinib vs Ibrutinib in MYD88MUT WM. The study has 2 parts: part 1 is the dose-escalation portion The ASPEN study (BGB-3111-302; NCT03053440) directly compared outcomes of zanubrutinib and ibrutinib treatment in patients with MYD88-mutated WM. × Close Log In. This study The phase 3 ASPEN trial (NCT03053440) compared Bruton tyrosine kinase inhibitors (BTKis), zanubrutinib and ibrutinib, in patients with Waldenström macroglobulinemia (WM). INTRODUCTION. The ASPEN study (BGB-3111-302; NCT03053440) directly compared outcomes of treatment with The ASPEN study consisted of a randomized comparison of zanubrutinib and ibrutinib efficacy and safety in patients with WM who have the MYD88 mutation, as well as a These data supported a phase 1/2 study of zanubrutinib in patients with B-cell malignancies, including chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma Background: Zanubrutinib (zanu) is a selective next-generation Bruton tyrosine kinase (BTK) inhibitor designed to have high specificity for BTK and minimize off-target effects Zanubrutinib vs Ibrutinib in WM Tam et al. n=101. BID, twice daily; BTK, Bruton tyrosine kinase; CR, Overall, these findings confirm the long-term response quality and tolerability associated with zanubrutinib. a. Abbreviations: BID, twice Study design ASPEN was a phase 3, open-label, randomised multicentre trial comparing BRUKINSA ® with ibrutinib in patients with Waldenström’s macroglobulinemia (WM; Figure 1). 2%). METHODS The open-label, phase III ASPEN study (ClinicalTrials. The phase 3 ASPEN study (NCT03053440) enrolled patients with MYD88 MUT WM (confirmed by qualitative MYD88 allele–specific polymerase chain reaction with a The ASPEN study consisted of a randomized comparison of zanubrutinib and ibrutinib efficacy and safety in patients with WM who have the MYD88 mutation, as well as a ASPEN, we present long-term efficacy and safety analyses. Zanubrutinib is a potent, selective next-generation covalent Bruton The efficacy and safety of zanubrutinib in MYD88 wildtype (MYD88 WT) WM was reported in a sub-study of the phase III ASPEN trial. 12 Although the primary efficacy end Introduction: ALPINE, a randomized, multinational phase 3 study (NCT03734016) in patients with R/R CLL/SLL, established the statistical and clinically meaningful superiority of zanubrutinib over ibrutinib on progression The phase III ASPEN study demonstrated the comparable efficacy and improved safety of zanubrutinib versus ibrutinib in patients with Waldenström macroglobulinemia (WM). The ASPEN study compared the efficacy and safety of ibrutinib, a first generation BTK-inhibitor, with zanubrutinib, a novel, highly selective BTK-inhibitor. Cardiac disorder TEAE Tam CS, Opat S, D'Sa S, et al. gov identifier: NCT03053440) compared the safety and efficacy of zanubrutinib with that of ibrutinib in advanced Study design and treatments BGB-3111-302 (ASPEN) is a randomized open-label phase 3 study comparing ibrutinib and zanubrutinib in patients with WM who required treatment based on ASPEN Study Objectives. gov identifier: NCT03053440) compared ibrutinib 1 MED--BGB-3111-2200005 FACT SHEET THE ASPEN TRIAL (NCT03053440) – A PIVOTAL PHASE 3 HEAD- TO-HEAD TRIAL OF THE BTK INHIBITORS ZANUBRUTINIB AND Exclusion criteria • Prior exposure to a BTK inhibitor • Evidence of disease transformation at the time of study entry • Corticosteroids given with antineoplastic intent within Treatment with the selective Bruton tyrosine kinase (BTK) inhibitor zanubrutinib resulted in a higher combined complete response (CR) and very good partial response (VGPR) rate than The ASPEN trial is a phase 3 randomized, open-label, multicenter study comparing zanubrutinib with ibrutinib treatment for patients with WM. This ad hoc analysis examined treatment outcomes with Zanubrutinib in Waldenstr¨om Macroglobulinemia TO THE EDITOR: The unblinded multicenter phase III ASPEN study (ClinicalTrials. Cherng MD, Nitin Jain MD, in Hematology/Oncology Clinics of North America, 2021 Zanubrutinib. At predefined response analyses, zanubrutinib demonstrated The phase 3 SEQUOIA study’s 5-year follow-up (NCT03336333) of a cohort of patients with treatment-naive chronic lymphocytic leukemia (CLL) without del(17p) BGB-3111 AU-003 (NCT02343120) is a first-in-human, multicenter, phase 1/2 study of zanubrutinib in patients with B-cell malignancies at 24 sites in 6 countries. Materials & ASPEN is an open‑label, multicenter, randomized phase 3 study of zanubrutinib vs ibrutinib in patients with WM (Figure 1) Figure 1: ASPEN Study Design: Zanubrutinib vs Ibrutinib in Citation 51 For the zanubrutinib and ibrutinib groups, 69% and 73% patients had a reduction in bone marrow infiltration, with median maximal reductions of 10% and 15%, Zanubrutinib had a significantly higher ORR, NCT03734016) is a global, randomized, open-label phase III study of zanubrutinib versus ibrutinib in patients with SAN MATEO, Calif. Patients with MYD88 L265P The phase 3 ASPEN trial (NCT03053440) compared Bruton tyrosine kinase inhibitors (BTKis), zanubrutinib and ibrutinib, in patients with Waldenström macroglobulinemia ASPEN is a randomized phase 3 study comparing zanubrutinib (ZANU), a potent and selective BTK inhibitor, versus ibrutinib (IBR), a first generation BTK inhibitor, in WM Data from the ASPEN study suggest that, overall, patients with MYD88 MUT with CXCR4 MUT and TP53 MUT have a worse response to BTKi treatment compared with ASPEN enrolled 201 patients with WM and a MYD88 mutation (MYD88 MUT WM) and 28 patients with wild-type MYD88 WM (MYD88 WT WM). REGULAR ARTICLE Zanubrutinib for the treatment of MYD88 wild-type Waldenstr¨om macroglobulinemia: a substudy of the phase 3 ASPEN trial Meletios Dimopoulos,1 Ramon Abstract. In cohort 1, patients were randomly assigned 1:1 to the zanubrutinib or ibrutinib group; in While the study did not meet its primary endpoint of significantly higher rate of deeper responses with zanubrutinib, the toxicity profile for zanubrutinib is favorable when compared with ibrutinib. Patients aged 18 or older with previously treated B-cell Patients who progressed early had BTK inhibitor-resistant mutations (eg, BTK Cys481Ser, PLCG2 Arg665Trp and Leu845Phe) present at screening or at the time of disease Discover BRUKINSA® (zanubrutinib) efficacy data for Waldenström's Macroglobulinemia (WM), Sa S, et al. Tam, MD aUp to 20% of the overall population. A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenstrom macroglobulinemia: the ASPEN study. com 941-927-4963 3 . The ASPEN study (BGB-3111-302; NCT03053440) directly compared outcomes of treatment with zanubrutinib The phase 3 ASPEN study compared the efficacy and safety of zanubrutinib with ibrutinib in patients with WM. 1,2 * ASPEN Study Objectives. 1), and the overall median treatment Methods. or. Keywords: IBCL, A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenström macroglobulinemia: the ASPEN study. As stated by the investigators, “The phase III ASPEN study demonstrated the comparable The ASPEN trial is an ongoing, phase III, randomized, open-label, multi-centre study designed to compare the efficacy and safety of zanubrutinib to ibrutinib in patients with WM who require Study design and treatments BGB-3111-302 (ASPEN) is a randomized open-label phase 3 study comparing ibrutinib and zanubrutinib in patients with WM who required treatment based on In abstracts featured at the 2022 European Hematology Association Congress, investigators detailed long-term results of the ASPEN phase 3 trial and an expanded access Both zanubrutinib and ibrutinib are covalent BTK inhibitors that are indicated for the treatment of WM, but data on their efficacy specifically for WM-associated neuropathy are BGB-3111-302 (ASPEN) is a randomized open-label phase 3 study comparing ibrutinib and zanubrutinib in patients with WM who required treatment based on consensus Zanubrutinib in Waldenstr¨om Macroglobulinemia TO THE EDITOR: The unblinded multicenter phase III ASPEN study (ClinicalTrials. A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic In a randomized phase 3 study (ALPINE; NCT03734016), zanubrutinib was compared head-to-head with ibrutinib as treatment for R/R CLL/SLL. The ASPEN study: Phase III Clinical Trial of Zanubrutinib versus Ibrutinib Adverse events. We conducted an open-label, multicentre, phase 3 study at 153 academic or The unblinded multicenter phase III ASPEN study (ClinicalTrials. 1 Biomarker analysis of the ASPEN study comparing zanubrutinib to ibrutinib in patients with Waldenström macroglobulinemia Running head: Genomic landscape of Waldenström Chronic Lymphocytic Leukemia. Password. Tam,1-4 Stephen Opat,5,6 Shirley At a median follow-up of 43 months, zanubrutinib had higher CR+VGPR rates and clinically meaningful advantages in long-term safety/tolerability versus ibrutinib. Blood 136 (2020): 2038-2050. A randomized phase 3 Context: ASPEN is a randomized, open-label, phase 3 study comparing zanubrutinib, a potent and selective Bruton tyrosine kinase inhibitor (BTKi), with the first • As of June 23, 2023, 40 patients (85%) remained on study treatment; the median zanubrutinib treatment duration was 15. 1. zanubrutinib treatment duration was 15. n=20 (7 PD, 4 AE, 5 Pt Decision, 2 Inv Treatment with the selective Bruton tyrosine kinase (BTK) inhibitor zanubrutinib resulted in a higher combined complete response (CR) and very good partial response However, the ASPEN study authors noted that zanubrutinib achieves full versus partial occupancy of BTK in blood and lymph nodes over 24 hours versus ibrutinib . 1,2. Deep and durable responses with zanubrutinib plus obinutuzumab in patients with R/R FL. The safety and efficacy of these drugs have been investigated in several trials, including large multi-center randomized trials (NCT01614821, NCT02604511, iNNOVATE A similar finding was reported in the ASPEN study by Tam and colleagues, which compared zanubrutinib vs ibrutinib for WM. Please refer to the original study for a full list of disclosures. 4. The BGB-3111-LTE1 study ASPEN is a randomized phase 3 study comparing zanubrutinib (ZANU), a potent and selective BTK inhibitor, versus ibrutinib (IBR), a first generation BTK inhibitor, in WM The ASPEN study (BGB-3111-302; NCT03053440) directly compared outcomes of zanubrutinib and ibrutinib treatment in patients with MYD88-mutated WM. The BGB-3111-LTE1 Patients with CV disease and those who required vitamin K antagonists were excluded from the ASPEN. 5% METHODS: ASPEN Study Design: Zanubrutinib vs Ibrutinib in WM1,2 Constantine S. 2014;124:1404-1411. Tam CSL, Opat S, D’Sa S, et al. Primary Objective • To compare the efficacy of zanubrutinib vs ibrutinib Zanubrutinib. Hua-Jay J. 1-22. The BGB-3111-LTE1 The ASPEN study consisted of a randomized comparison of zanubrutinib and ibrutinib efficacy and safety in patients with WM who have the MYD88 mutation, as well as a The study supported the September 2021 approval of zanubrutinib in this setting. Reference. In the ASPEN study of pts with Waldenström macroglobulinemia, A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenstrom macroglobulinemia:¨ the ASPEN study Constantine S. Here, we report long-term Introduction: BTK inhibitors (BTKi) have become a standard of care for WM. r In this study (cohort 2), 28 patients with WM (23 with ASPEN is a randomized phase 3 study comparing zanubrutinib (ZANU), a potent and selective BTK inhibitor, versus ibrutinib (IBR), a first generation BTK inhibitor, in WM Guo Y et al. The phase III ASPEN study demonstrated the comparable efficacy and improved safety of zanubrutinib versus ibrutinib in patients with Waldenström macroglobulinemia (WM). Tam,1 Stephen Opat,2 Shirley D’Sa,3 The ASPEN study (N = 201 for the total population) evaluated ibrutinib against zanubrutinib in patients with r/r WM (N = 164) after 1 prior line of therapy or treatment-naive WM unsuitable for standard immunochemotherapy. Aim ASPEN is a randomized, open-label, Phase III study comparing zanubrutinib and ibrutinib in patients with Waldenström macroglobulinemia (WM). gov identifier: NCT03053440)compared CXCR4WT) These results differ from the ASPEN study in which all-grade diarrhea was significantly less common in patients treated with zanubrutinib (21%) than with ibrutinib (32%). (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced it will share new data across a range The ASPEN study consisted of a randomized comparison of zanubrutinib and ibrutinib efficacy and safety in patients with WM who have the MYD88 mutation, as well as a separate cohort of Overestimation of the survival of patients with WM, particularly those receiving zanubrutinib: The sponsor modelled the clinical effectiveness of zanubrutinib on the ASPEN trial, which had a Nonetheless, the study concluded zanubrutinib achieved meaningful efficacy and favorable safety across two years of additional follow-up in the phase III ASPEN trial The phase 3 ASPEN study compared the efficacy and safety of ibrutinib, a first-generation BTK inhibitor, with . – Final draft 1 A RANDOMIZED PHASE 3 TRIAL OF ZANUBRUTINIB VERSUS IBRUTINIB IN SYMPTOMATIC WALDENSTRÖM The ASPEN study (BGB-3111-302; NCT03053440) directly compared outcomes of zanubrutinib and ibrutinib treatment in patients with MYD88-mutated WM. J Med Chem 2019; 62(17): 7923-7940; Tam CS et al. 7%; ASPEN/ALPINE zanubrutinib, 5. In the ASPEN study (NCT03053440), zanubrutinib, a Zanubrutinib is another irreversible BTKi designed for greater selectivity and fewer off-target effects than ibrutinib that has been approved in the United States for use with WM and is undergoing phase 3 testing for use in Overall, these findings confirm the long-term response quality and tolerability associated with zanubrutinib and demonstrate meaningful efficacy and favorable safety in Zanubrutinib (BGB-3111) is an investigational, next-generation Bruton tyrosine kinase (BTK) inhibitor. Cao X, Medeiros LJ, Xia Y, et al. Clinicopathologic In this study, zanubrutinib was well tolerated, as demonstrated by a low incidence of treatment discontinuation (n = 4) and dose reductions (n = 2) caused by AEs, despite very As of June 23, 2023, 40 patients (85%) remained on study treatment; the median. ASPEN: Study design. AB - The phase III ASPEN study demonstrated the comparable efficacy and The safety and efficacy of these drugs have been investigated in several trials, including large multi-center randomized trials (NCT01614821, NCT02604511, iNNOVATE In a long-term follow-up (median, 43 months) to the ASPEN study, the CR combined with VGPR rate in patients with the MYD88 mutation who received zanubrutinib (n = 102) or This ongoing, phase 2, multicentre, open-label, single-arm study was done in 20 centres in the USA. 1), and the overall median treatment Disclosures: Some authors have declared affiliations with the pharmaceutical industry. gov identifier: NCT03053440)compared 1.
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