Journal
JOURNAL OF HEMATOLOGY & ONCOLOGY
Volume 14, Issue 1, Pages -Publisher
BMC
DOI: 10.1186/s13045-021-01188-x
Keywords
Hematological cancers; lymphomas; Small molecule agents; kinase inhibitors; Ibrutinib; Venetoclax; Safety
Categories
Funding
- Pharmacyclics LLC, an AbbVie Company
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Ibrutinib plus venetoclax has shown promising clinical activity in mantle cell lymphoma patients, with concurrent administration without an ibrutinib lead-in. The overall response rate was 81% and complete response rate was 62%, with no new safety signals observed in the safety run-in cohort.
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: ClinicalTrials.gov, NCT03112174. Registered 13 April 2017, .
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