{"id":7389,"date":"2025-06-12T06:00:00","date_gmt":"2025-06-12T04:00:00","guid":{"rendered":"https:\/\/beigen.vipdev.lndo.site\/us\/?post_type=congress-resource&#038;p=7389"},"modified":"2025-06-12T02:06:58","modified_gmt":"2025-06-12T00:06:58","slug":"combination-of-zanubrutinib-zanu-venetoclax-ven-for-treatment-naive-tn-cll-sll-results-in-sequoia-arm-d","status":"publish","type":"congress-resource","link":"https:\/\/beonemedaffairs.com\/us\/congress-resource\/7389\/combination-of-zanubrutinib-zanu-venetoclax-ven-for-treatment-naive-tn-cll-sll-results-in-sequoia-arm-d\/","title":{"rendered":"Combination of zanubrutinib (zanu) + venetoclax (ven) for treatment-naive (TN) CLL\/SLL: Results in SEQUOIA arm D"},"content":{"rendered":"","protected":false},"template":"","post-tag":[774,614,613,612,629,628,781,775,777,706,563,779,780,778,776,542],"class_list":["post-7389","congress-resource","type-congress-resource","status-publish","hentry","post-tag-arm-d","post-tag-bcl-2-inhibitor","post-tag-brutons-tyrosine-kinase","post-tag-brutons-tyrosine-kinase-inhibitor","post-tag-btk","post-tag-btki","post-tag-cll-sll","post-tag-combination-therapy","post-tag-del17p","post-tag-eha","post-tag-sequoia","post-tag-tn-cll","post-tag-tn-sll","post-tag-treatment-naive-chronic-lymphocytic-leukemia-small-lymphocytic-leukemia","post-tag-venetoclax","post-tag-zanubrutinib","congress_resource_type-poster","content_type-reading","disease_state-chronic-lymphocytic-leukemia","disease_state-small-lymphocytic-lymphoma","molecule-zanubrutinib"],"acf":{"congress_resource_url_override":"","congress":6813,"category":245,"prioritization":0,"key_data_presentation":false,"key_data_presentation_only":false,"key_data_presentation_prioritization":0,"tags":[563,774,775,776,614,777,778,779,780,781,613,612,629,628,542],"visible_tags":[706,781,542],"content-type":246,"summary":"","text_app":"&nbsp;\r\n\r\n&nbsp;","text":"<strong>FOR US HEALTHCARE PROFESSIONALS<\/strong>\r\n\r\n<strong>IMPORTANT INFORMATION FOR THE HEALTHCARE PROFESSIONAL<\/strong>\r\n\r\nBRUKINSA\u00ae (zanubrutinib) in combination with venetoclax followed by continuous zanubrutinib monotherapy has not been approved by FDA for use in previously untreated CLL and the safety and effectiveness of BRUKINSA\u00ae (zanubrutinib) in combination with venetoclax followed by continuous zanubrutinib monotherapy in previously untreated CLL has not been established.\r\nBRUKINSA is a kinase inhibitor FDA approved for the treatment of adult patients with:\r\n<ul>\r\n \t<li>Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)<\/li>\r\n \t<li>Waldenstr\u00f6m\u2019s macroglobulinemia (WM)<\/li>\r\n \t<li>Mantle cell lymphoma (MCL) who have received at least one prior therapy.<\/li>\r\n \t<li>Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.<\/li>\r\n \t<li>Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy.<\/li>\r\n<\/ul>\r\nThe MCL, MZL and FL indications are approved under accelerated approval based on overall response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.\r\n\r\n<strong>Please see Important Safety Information below and full <a href=\"https:\/\/d1e94vsyskgtht.cloudfront.net\/brukinsa\/pdfs\/brukinsa-prescribing-information.pdf\">Prescribing Information<\/a>, including <a href=\"https:\/\/d1e94vsyskgtht.cloudfront.net\/brukinsa\/pdfs\/brukinsa-patient-information.pdf\">Patient Information<\/a> for BRUKINSA.<\/strong>\r\n\r\nBeOne Medicines provided sponsorship\/funding and supplies for the study discussed in this reprint. The authors may have received compensation from BeOne Medicines in connection with this study or from BeOne Medicines for other engagements.\r\n\r\nBeOne Medicines recommends the use of BRUKINSA only in accordance with its FDA-approved Prescribing Information.\r\n\r\nPrescription drugs used outside of an approved indication may not be eligible for reimbursement by third-party payors, including Medicare and Medicaid.\r\n\r\nThis information is intended for educational purposes only. For any questions about the BeOne products mentioned, please contact Medical Information at medicalinformation@beonemed.com; adverse events should be reported by calling 1 (781) 801-1800 or emailing adverse_event@beonemed.com. For any questions about the non-BeOne products mentioned in this paper, please contact the respective manufacturers.\r\n\r\n<strong>IMPORTANT SAFETY INFORMATION ABOUT BRUKINSA\u00ae (ZANUBRUTINIB)<\/strong>\r\n\r\n<span style=\"text-decoration: underline;\"><strong>Warnings and Precautions<\/strong><\/span>\r\n\r\n<strong>Hemorrhage<\/strong>\r\n\r\nFatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria, and hemothorax was reported in 3.8% of patients treated with BRUKINSA in clinical trials, with fatalities occurring in 0.2% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 32% of patients.\r\n\r\nBleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage.\r\n\r\nMonitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days before and after surgery depending upon the type of surgery and the risk of bleeding.\r\n\r\n<strong>Infections<\/strong>\r\n\r\nFatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher infections occurred in 26% of patients, most commonly pneumonia (7.9%), with fatal infections occurring in 3.2% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred.\r\n\r\nConsider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately.\r\n\r\n<strong>Cytopenias<\/strong>\r\n\r\nGrade 3 or 4 cytopenias, including neutropenia (21%), thrombocytopenia (8%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA. Grade 4 neutropenia occurred in 10% of patients, and Grade 4 thrombocytopenia occurred in 2.5% of patients.\r\n\r\nMonitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed.\r\n\r\n<strong>Second Primary Malignancies<\/strong>\r\n\r\nSecond primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA. The most frequent second primary malignancy was non-melanoma skin cancers (8%), followed by other solid tumors in 7% of the patients (including melanoma in 1% of patients) and hematologic malignancies (0.7%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies.\r\n\r\n<strong>Cardiac Arrhythmias<\/strong>\r\n\r\nSerious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 4.4% patients treated with BRUKINSA, including Grade 3 or higher cases in 1.9% of patients. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.3% of patients.\r\n\r\nMonitor for signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment.\r\n\r\n<strong>Hepatotoxicity, Including Drug-Induced Liver Injury<\/strong>\r\n\r\nHepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including BRUKINSA.\r\n\r\nEvaluate bilirubin and transaminases at baseline and throughout treatment with BRUKINSA. For patients who develop abnormal liver tests after BRUKINSA, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold BRUKINSA. Upon confirmation of DILI, discontinue BRUKINSA.\r\n\r\n<strong>Embryo-Fetal Toxicity<\/strong>\r\n\r\nBased on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.\r\n\r\n<strong>Adverse Reactions<\/strong>\r\n\r\nThe most common adverse reactions (\u226530%), including laboratory abnormalities, in patients who received BRUKINSA (N=1729) are decreased neutrophil count (51%), decreased platelet count (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%).\r\n\r\nDrug Interactions\r\n\r\n<strong>CYP3A Inhibitors:<\/strong>\u202fWhen BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily.\r\n\r\n<strong>CYP3A Inducers:<\/strong>\u202fAvoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers.\r\n\r\n<span style=\"text-decoration: underline;\"><strong>Specific Populations<\/strong><\/span>\r\n\r\n<strong>Hepatic Impairment:<\/strong> The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily.","table_heading":"","table":null,"faq_heading":"FREQUENTLY ASKED QUESTIONS","faq":null,"button_alt_link":"","no_post_image_preview":false,"download_file_reading":"https:\/\/beonemedaffairs.com\/us\/wp-content\/uploads\/sites\/11\/2025\/06\/Shadman_Zanu_304-ArmD_EHA-2025_Poster-final.pdf","display_file_reading":null,"download_file_slidekit":null,"display_file_slidekit":null,"3qsdn":"","webcast":"","vimeo_url":"","videolange":null,"fliphtml_link":"https:\/\/online.fliphtml5.com\/elkzy\/xqzz\/","use_pdf_instead_of_fliphtml":false,"congress_resource_abstract_link":"","congress_resource_cta_label":"","congress_resource_cta_link":"","authors":[6580],"field_page_schema_override":null},"_links":{"self":[{"href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/congress-resource\/7389","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/congress-resource"}],"about":[{"href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/types\/congress-resource"}],"acf:post":[{"embeddable":true,"href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/authors\/6580"},{"embeddable":true,"href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/congress\/6813"}],"acf:term":[{"embeddable":true,"taxonomy":"content_type","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/content_type\/246"},{"embeddable":true,"taxonomy":"post-tag","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/post-tag\/706"},{"embeddable":true,"taxonomy":"post-tag","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/post-tag\/542"},{"embeddable":true,"taxonomy":"post-tag","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/post-tag\/628"},{"embeddable":true,"taxonomy":"post-tag","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/post-tag\/629"},{"embeddable":true,"taxonomy":"post-tag","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/post-tag\/612"},{"embeddable":true,"taxonomy":"post-tag","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/post-tag\/613"},{"embeddable":true,"taxonomy":"post-tag","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/post-tag\/781"},{"embeddable":true,"taxonomy":"post-tag","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/post-tag\/780"},{"embeddable":true,"taxonomy":"post-tag","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/post-tag\/779"},{"embeddable":true,"taxonomy":"post-tag","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/post-tag\/778"},{"embeddable":true,"taxonomy":"post-tag","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/post-tag\/777"},{"embeddable":true,"taxonomy":"post-tag","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/post-tag\/614"},{"embeddable":true,"taxonomy":"post-tag","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/post-tag\/776"},{"embeddable":true,"taxonomy":"post-tag","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/post-tag\/775"},{"embeddable":true,"taxonomy":"post-tag","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/post-tag\/774"},{"embeddable":true,"taxonomy":"post-tag","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/post-tag\/563"},{"embeddable":true,"taxonomy":"congress_resource_type","href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/congress_resource_type\/245"}],"wp:attachment":[{"href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/media?parent=7389"}],"wp:term":[{"taxonomy":"post-tag","embeddable":true,"href":"https:\/\/beonemedaffairs.com\/us\/wp-json\/wp\/v2\/post-tag?post=7389"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}