{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T22:30:03Z","timestamp":1786487403628,"version":"build-2736575974"},"reference-count":33,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"23","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["J Clin Oncol"],"published-print":{"date-parts":[[2026,8,10]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>Mantle cell lymphoma (MCL) is a rare and typically aggressive B-cell non-Hodgkin lymphoma characterized by recurrent relapse after short remissions. Sonrotoclax (BGB-11417) is a next-generation B-cell lymphoma 2 inhibitor with greater selectivity and potency than venetoclax, a shorter half-life, and no drug accumulation. Sonrotoclax monotherapy was evaluated in Bruton tyrosine kinase inhibitor\u2013pretreated patients with relapsed\/refractory (R\/R) MCL.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>\n                      BGB-11417-201 (ClinicalTrials.gov identifier:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT05471843\">NCT05471843<\/jats:ext-link>\n                      ) is an ongoing global, open-label, phase I\/II trial. Sonrotoclax was orally administered once daily with gradual, 4-week ramp-up to 160 mg or 320 mg to mitigate tumor lysis syndrome (TLS). The primary end point was overall response rate by the independent review committee (ORR-IRC) per Lugano classification; secondary end points included duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      Overall, 125 patients were enrolled and assigned to receive sonrotoclax 160 mg (n = 10) or 320 mg (n = 115) target doses once daily. Most patients had advanced disease (stage IV, 78.3%) and were heavily pretreated (median prior therapies, 3). In efficacy-evaluable patients (n = 103), the ORR-IRC was 52.4% (95% CI, 42.4 to 62.4), a statistically significant increase versus the historic control ORR (30%;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt; .0001); the complete response rate was 15.5%. Responses were seen across high-risk subgroups, including patients with\n                      <jats:italic toggle=\"yes\">TP53<\/jats:italic>\n                      mutation (59.1%). With a median study follow-up of 14.2 months, the median DOR-IRC was 15.8 months, and the median PFS-IRC was 6.5 months. Median OS was not reached. The most common all-grade\/grade \u22653 treatment-emergent adverse events were neutropenia (35.7%\/19.1%), thrombocytopenia (24.3%\/9.6%), and anemia (24.3%\/7.8%). TLS occurred in 7.0% of patients; all cases resolved without sequelae.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>Sonrotoclax demonstrated rapid, durable responses and manageable safety in heavily pretreated patients with R\/R MCL, including high-risk subgroups, supporting its further clinical evaluation as an oral therapy for R\/R MCL.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco-26-00550","type":"journal-article","created":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T20:00:32Z","timestamp":1782936032000},"page":"2233-2243","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":0,"title":["Phase I\/II Study of Sonrotoclax (BGB-11417) Monotherapy in Patients With Mantle Cell Lymphoma Previously Treated With Anti-CD20 Therapy and a Bruton Tyrosine Kinase Inhibitor"],"prefix":"10.1200","volume":"44","clinical-trial-number":[{"clinical-trial-number":"nct05471843","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6631-9749","authenticated-orcid":false,"given":"Toby A.","family":"Eyre","sequence":"first","affiliation":[{"name":"Oxford Cancer and Haematology Centre, Churchill Hospital, Headington, Oxford, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3067-5554","authenticated-orcid":false,"given":"Yuqin","family":"Song","sequence":"additional","affiliation":[{"name":"Peking University Cancer Hospital and Institute, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2574-3874","authenticated-orcid":false,"given":"Olivier","family":"Hermine","sequence":"additional","affiliation":[{"name":"Necker Hospital Assistance Publique H\u00f4pitaux de Paris, Paris Cit\u00e9 University, 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