Long-term Follow-up of Patients with Relapsed or Refractory Non–Hodgkin Lymphoma Treated with Venetoclax in a Phase I, First-in-Human Study

Abstract

Genentech would like to thank the patients, their families and caregivers, as well as the M12-175 study investigators, research, and supporting staff.Medical writing support was provided by Dalia Majumdar, PhD, of AbbVie. Data Sharing StatementAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual, and trial-level data (analysis data sets), as well as other information (e.g., protocols and Clinical Study Reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.This clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. For more information on the process, or to submit a request, visit the following link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-andinformation-sharing/data-and-information-sharing-with-qualified-researchers.html

Mantle cell lymphoma in 2022—A comprehensive update on molecular pathogenesis, risk stratification, clinical approach, and current and novel treatments

“…The median PFS was 11.3 months after longer follow-up of 38 months. 158 Venetoclax has promising activity in BTKi-refractory MCL. One multicenter European study 159 described efficacy of venetoclax monotherapy in 20 patients with relapsed MCL (median 3 prior lines of therapy).…”

Relapsed/Refractory Mantle Cell Lymphoma: Beyond BTK Inhibitors

“…About 90% of MCL cases overexpress B-cell lymphoma 2 (Bcl-2), which plays a role in protecting MCL cells from apoptogenic signals. Venetoclax, a Bcl-2 inhibitor, has shown single-agent activity in a phase I study in patients with MCL without prior BTKi treatment, and limited data regarding the efficacy of venetoclax post-BTKi therapy [ 41 ]. There is a small report of 20 patients with R/R MCL and prior BTKi treatment who were treated with venetoclax alone in the United Kingdom, with a 53% ORR and 18% CR; however, the median PFS was only 3 months [ 42 ].…”

The mitochondrial anti-apoptotic dependencies of hematologic malignancies: from disease biology to advances in precision medicine

“… 69 Less common subtypes of B-NHL, including follicular lymphoma and mantle cell lymphoma, display better clinical responses to BCL-2 inhibition. 69 , 70 However, durable remissions are not frequent and may require combination therapies. At least in follicular lymphoma, in which high BCL-2 expression caused by the t(14;18) translocation has ever been considered the pathogenic hallmark, concurrent antagonism of microenvironment-induced BCLxL is needed to efficiently trigger apoptosis.…”