Addition of tafasitamab, a humanized CD19-targeting monoclonal antibody (mAb), to lenalidomide plus rituximab resulted in significant and clinically meaningful improvement in progression-free survival (PFS), representing a 57% reduction in risk of progression, relapse, or death in patients with relapsed or refractory follicular lymphoma (FL), according to the results of a phase 3 study presented at the 66th American Society of Hematology Annual Meeting and Exposition in San Diego, California.
The study is the first to validate combining two mAbs (anti-CD19 with anti-CD20) in the treatment of lymphoma, according to the authors, led by Laurie H. Sehn, MD, MPH, of the BC Cancer Centre for Lymphoid Cancer and the University of British Columbia in Vancouver, Canada.
A total of 548 adult patients with relapsed or refractory CD19-positive and CD20-positive FL (grade 1-3A) and Eastern Cooperative Oncology Group (ECOG) performance status ≤2, requiring treatment after ≥1 lines of prior systemic therapy including an anti-CD20 mAb, were randomized 1:1 to receive tafasitamab 12 mg/kg iv (n=273) or placebo (n=275) on days (D) 1, 8, 15, and 22 of cycles (C) 1-3 and D1 and D15 of C4-12 with standard dosing of lenalidomide plus rituximab for up to twelve 28-day cycles.
With a median follow-up of 14.1 months, addition of tafasitamab to lenalidomide plus rituximab resulted in significantly lower risk of progression, relapse, or death versus the placebo.
In terms of safety, a similar rate of treatment-emergent adverse events (TEAEs) (99% vs 99%), grade 3 or 4 AEs (71% vs 69.5%), and serious AEs (36% vs 32%) were observed with tafasitamab and placebo, respectively. The most common grade 3 or 4 AEs with tafasitamab versus placebo were neutropenia (40% vs 38%), pneumonia (8% vs 5%), thrombocytopenia (6% vs 7%), decreased neutrophils (6% vs 7%), COVID-19 (6% vs 2%), and COVID-19 pneumonia (5% vs 1%).
“Addition of [tafasitamab] to [lenalidomide plus rituximab] resulted in significant and clinically meaningful improvement in PFS, representing a 57% reduction in risk of progression, relapse, or death in patients with [relapsed or refractory] FL,” the authors wrote. “[tafasitamab plus lenalidomide plus R] can be administered in community as well as academic settings and represents a potential new standard-of-care option for patients with [relapsed or refractory] FL.”
Reference
Sehn L, Luminari S, Scholz C.Tafasitamab Plus Lenalidomide and Rituximab for Relapsed or Refractory Follicular Lymphoma: Results from a Phase 3 Study (inMIND). Abstract #LBA-1. December 7-10. San Diego, California.
