FDA Approved Tafasitamab Plus Lenalidomide in Relapsed/Refractory DLBCL
It is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody.
It enhances antibody dependent cellular cytotoxicity and phagocytosis with potent in vivo activity.
The FDA has approved tafasitamab-cxix in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.
Trade name Monjuvi.
Approved tafasitamab-cxix (Monjuvi) in combination with lenalidomide (Revlimid) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) ,including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.
Phase 2 L-MIND trial, demonstrated that tafasitamab in combination the lenalidomide elicited an ORR of 55%, which was comprised of a complete response (CR) rate of 37% and a partial response (PR) rate of 18%.
The median duration of response in the study was 21.7 months.
The overall response rate
was 58% with a CR rate of 33% and a PR rate of 25%.
The 12-month duration of rrsponse in this population was 70.1%; it was even higher in those who achieved a CR, at 87.0%.
Tafasitamab side facts: infusion-related reactions (6%), serious or severe myelosuppression, including neutropenia (50%), thrombocytopenia (18%), anemia (7%), infections (73%), and embryo-fetal toxicity.
Analysis demonstrated a statistically significant superior best overall response rate with the combination compared with lenalidomide alone, at 67.1% versus 34.2%, respectively.
The CR rates were 39.5% and 11.8% with the combination and the monotherapy, respectively.
The median OS had not yet been reached in the combination arm versus 9.3 months in the single-agent arm.