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Phase III Study to Evaluate Tafasitamab-cxix–Based Therapy for Advanced B-Cell Lymphoma

By: Vanessa A. Carter, BS
Posted: Friday, July 1, 2022

To be conducted by Laurie Helen Sehn, MD, MPH, of the Cancer Centre for Lymphoid Cancer and University of British Columbia, Vancouver, Canada, and colleagues, the phase III inMIND study will focus on the combination of the anti-CD19 monoclonal antibody tafasitamab-cxix plus lenalidomide and rituximab in patients with various non-Hodgkin lymphomas. The projected methods for this study were presented during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract TPS7583).

“Most patients with the indolent non-Hodgkin lymphoma subtypes follicular or marginal zone respond to first-line treatment, but relapse is common, and there is no single standard treatment for patients with relapsed/refractory [disease],” stated the study authors. “Preclinical and clinical observations from phase II trials suggest a potential clinical benefit of tafasitamab plus lenalidomide and rituximab for [these] patients.”

A phase IIa study (Clinical Trial identifier NCT01685008) previously concluded that tafasitamab monotherapy demonstrated clinical activity in patients with relapsed/refractory disease, with an objective response rate of around 33%. Another ongoing phase II study (NCT02399085) evaluating tafasitamab plus lenalidomide demonstrated an objective response rate of 57.5% in patients with diffuse large B-cell lymphoma, further supporting the use of tafasitamab in this population.

This phase III, placebo-controlled, randomized study aims to evaluate whether tafasitamab plus lenalidomide and rituximab offers clinical benefit in patients with relapsed/refractory non-Hodgkin lymphoma when compared with lenalidomide and rituximab alone. Participants will be randomly assigned 1:1 to receive lenalidomide and rituximab plus either tafasitamab or placebo.

Notably, stratified randomization is to be performed separately for patients with follicular or marginal zone lymphoma. The primary endpoint of this study is progression-free survival in patients with follicular lymphoma, and secondary endpoints include progression-free survival among the overall population, the PET-complete response rate at the end of treatment, and overall survival in those with follicular lymphoma. Study enrollment is ongoing.

Disclosure: For full disclosures of the study authors, visit coi.asco.org.


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