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Title: Concurrent ibrutinib plus venetoclax in relapsed/refractory mantle cell lymphoma: the safety run-in of the phase 3 SYMPATICO study.
Austin Authors: Wang, Michael T ;Ramchandren, Radhakrishnan;Chen, Robert;Karlin, Lionel;Chong, Geoffrey ;Jurczak, Wojciech;Wu, Ka Lung;Bishton, Mark;Collins, Graham P;Eliadis, Paul;Peyrade, Frédéric;Lee, Yihua;Eckert, Karl;Neuenburg, Jutta K;Tam, Constantine S
Affiliation: Peter MacCallum Cancer Centre, Royal Melbourne Hospital, St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia
Department of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd #368, Houston, TX, 77030, USA
Icon Cancer Centre, South Brisbane, QLD, Australia
Olivia Newton-John Cancer Wellness and Research Centre
University of Tennessee, Knoxville, TN, USA
City of Hope National Medical Center, Duarte, CA, USA
Centre Hospitalier Lyon Sud, Lyon, France
Sklodowska Curie National Research Institute of Oncology, Kraków, Poland
Ziekenhuis Netwerk Antwerpen, Antwerp, Belgium
Nottinghamshire University Hospitals, Nottingham, UK
NIHR Oxford Biomedical Research Centre, Churchill Hospital, Oxford, UK
Centre Antoine Lacassagne, Nice Cedex 2, France
Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA
Issue Date: 30-Oct-2021
Date: 2021-10-30
Publication information: Journal of Hematology & Oncology 2021; 14(1): 179
Abstract: Ibrutinib plus venetoclax, given with an ibrutinib lead-in, has shown encouraging clinical activity in early phase studies in mantle cell lymphoma (MCL). The ongoing phase 3 SYMPATICO study evaluates the safety and efficacy of concurrently administered, once-daily, all-oral ibrutinib plus venetoclax in patients with relapsed/refractory MCL. A safety run-in (SRI) cohort was conducted to inform whether an ibrutinib lead-in should be implemented for the randomized portion. Patients received concurrent ibrutinib 560 mg continuously plus venetoclax in a 5-week ramp-up to venetoclax 400 mg for up to 2 years. The primary endpoint was occurrence of tumor lysis syndrome (TLS) and dose-limiting toxicities (DLTs). The SRI cohort enrolled 21 patients; six and 15 were in low- or increased-risk categories for TLS, respectively. During the 5-week venetoclax ramp-up, three patients had DLTs, and one patient at increased risk for TLS had a laboratory TLS; no additional TLS events occurred during follow-up. With a median follow-up of 31 months, the overall response rate was 81% (17/21); 62% (13/21) of patients had a complete response. SRI data informed that the randomized portion should proceed with concurrent ibrutinib plus venetoclax, with no ibrutinib lead-in. Ibrutinib plus venetoclax demonstrated promising efficacy; no new safety signals were observed.Trial registration:, NCT03112174. Registered 13 April 2017, .
DOI: 10.1186/s13045-021-01188-x
ORCID: 0000-0001-9748-5486
Journal: Journal of Hematology & Oncology
PubMed URL: 34717692
Type: Journal Article
Subjects: Hematological cancers/lymphomas
Small molecule agents/kinase inhibitors
Appears in Collections:Journal articles

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