Matching-adjusted indirect comparison from the Lymphoma Epidemiology of Outcomes Consortium for Real World Evidence (LEO CReWE) study to a clinical trial of mosunetuzumab in relapsed or refractory follicular lymphoma
Title: | Matching-adjusted indirect comparison from the Lymphoma Epidemiology of Outcomes Consortium for Real World Evidence (LEO CReWE) study to a clinical trial of mosunetuzumab in relapsed or refractory follicular lymphoma |
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Authors: | Matthew J. Maurer, Carla Casulo, Melissa C. Larson, Thomas M. Habermann, Izidore S. Lossos, Yucai Wang, Loretta J. Nastoupil, Christopher Strouse, Dai Chihara, Peter Martin, Jonathon B. Cohen, Brad S. Kahl, W Richard Burack, Jean L. Koff, Yong Mun, Anthony Masaquel, Mei Wu, Michael C. Wei, Ashwini Shewade, Jia Li, James R. Cerhan, Brian K. Link, Christopher R. Flowers |
Source: | Haematologica, Vol 999, Iss 1 (2023) |
Publisher Information: | Ferrata Storti Foundation, 2023. |
Publication Year: | 2023 |
Collection: | LCC:Diseases of the blood and blood-forming organs |
Subject Terms: | Diseases of the blood and blood-forming organs, RC633-647.5 |
More Details: | Mosunetuzumab is a novel bispecific antibody targeting epitopes on CD3 on T cells and CD20 on B cells with the goal of inducing T-cell mediated elimination of malignant B cells. A recent pivotal phase I/II clinical trial (GO29781) demonstrated that mosunetuzumab induced an overall response rate of 80%, complete response rate of 60%, and a median progression-free survival of 17.9 months in patients with relapsed/refractory (r/r) follicular lymphoma (FL) following at least two prior lines of systemic therapy, including alkylator and anti-CD20 antibody-based therapy. Historical data from cohorts receiving therapy for r/r FL can provide some context for interpretation of single-arm trials. We compared the results from the mosunetuzumab trial to outcomes from a cohort of patients with r/r FL from the LEO Consortium for Real World Evidence (LEO CReWE). We applied clinical trial eligibility criteria to the LEO CReWE cohort and utilized matching-adjusted indirect comparison weighting to balance the clinical characteristics of the LEO CReWE cohort with those from the mosunetuzumab trial. Overall response rates (73%, 95% CI:65-80%) and complete response rates (53%, 95% CI:45-61%) observed in the weighted LEO CReWE cohort were lower than those reported on the mosunetuzumab trial (ORR=80%, 95% CI:70-88%; CR=60%, 95% CI:49-70% respectively). Progression-free survival at 12 months was similar in the weighted LEO CReWE (60%, 95% CI:51-69%) and the mosunetuzumab trial (PFS 58%, 95% CI:47-68%). Sensitivity analyses examining the impact of matching variables, selection of line of therapy, and application of eligibility criteria, provide context for best practices in this setting. |
Document Type: | article |
File Description: | electronic resource |
Language: | English |
ISSN: | 0390-6078 1592-8721 |
Relation: | https://haematologica.org/article/view/11360; https://doaj.org/toc/0390-6078; https://doaj.org/toc/1592-8721 |
DOI: | 10.3324/haematol.2023.283737 |
Access URL: | https://doaj.org/article/1d7e46afb331468e9c6f00cad9ff0929 |
Accession Number: | edsdoj.1d7e46afb331468e9c6f00cad9ff0929 |
Database: | Directory of Open Access Journals |
ISSN: | 03906078 15928721 |
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DOI: | 10.3324/haematol.2023.283737 |
Published in: | Haematologica |
Language: | English |