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
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
Affiliations
Matthew J. Maurer
Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA, 55902; Division of Hematology, Mayo Clinic, Rochester, MN, USA, 55905
Carla Casulo
Department of Medicine, Wilmot Cancer Institute, University of Rochester, Rochester, NY, USA, 14642
Melissa C. Larson
Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA, 55902
Thomas M. Habermann
Division of Hematology, Mayo Clinic, Rochester, MN, USA, 55905
Izidore S. Lossos
Department of Medicine, Comprehensive Sylvester Cancer Center, University of Miami, Miami, FL, USA, 33124
Yucai Wang
Division of Hematology, Mayo Clinic, Rochester, MN, USA, 55905
Loretta J. Nastoupil
University of Texas, MD Anderson Cancer Center, Houston, TX, USA, 77030
Christopher Strouse
Department of Medicine, University of Iowa, Iowa City, IA, USA, 52242
Dai Chihara
University of Texas, MD Anderson Cancer Center, Houston, TX, USA, 77030
Peter Martin
Department of Medicine, Weill Cornell Medical College, New York, NY, USA, 10075
Jonathon B. Cohen
Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA, 30322
Brad S. Kahl
Department of Medicine, Washington University in St Louis, St Louis, MO, USA, 63130
W Richard Burack
Department of Medicine, Wilmot Cancer Institute, University of Rochester, Rochester, NY, USA, 14642
Jean L. Koff
Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA, 30322
Yong Mun
Genentech, Inc., South San Francisco, CA, USA, 94080
Anthony Masaquel
Genentech, Inc., South San Francisco, CA, USA, 94080
Mei Wu
Genentech, Inc., South San Francisco, CA, USA, 94080
Michael C. Wei
Genentech, Inc., South San Francisco, CA, USA, 94080
Ashwini Shewade
Genentech, Inc., South San Francisco, CA, USA, 94080
Jia Li
Genentech, Inc., South San Francisco, CA, USA, 94080
James R. Cerhan
Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA, 55902
Brian K. Link
Department of Medicine, University of Iowa, Iowa City, IA, USA, 52242
Christopher R. Flowers
University of Texas, MD Anderson Cancer Center, Houston, TX, USA, 77030
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.