The combination of tafasitamab-cxix with lenalidomide and rituximab has demonstrated improved progression-free survival (PFS) in patients with relapsed or refractory follicular lymphoma, according to findings from the phase 3 inMIND trial. This outcome marks a significant step forward in treating this challenging patient population, offering a potential new therapeutic option for those who have failed previous treatments.
The inMIND trial, a randomized phase 3 study, involved 654 adult patients with relapsed or refractory follicular lymphoma (grade 1 to 3A) or nodal, splenic, or extranodal marginal zone lymphoma. The primary endpoint was PFS, as assessed by investigators in patients with follicular lymphoma. Key secondary endpoints included PFS in the overall study population, PET complete response, and overall survival (OS) among patients with follicular lymphoma.
The trial successfully met both its primary and key secondary endpoints, indicating a clinically meaningful benefit for patients receiving the tafasitamab regimen. Tafasitamab-cxix, marketed as Monjuvi by MorphoSys and Incyte, is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. It is currently approved in the United States for use with lenalidomide in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, who are ineligible for autologous stem cell transplant.
No new safety signals were observed with tafasitamab in the trial. The most common adverse events reported included fatigue or weakness, cough, fever, diarrhea, respiratory tract infection, swelling of the hands or lower legs, and decreased appetite. These adverse events are consistent with the known safety profile of tafasitamab and other immunomodulatory therapies.
Regulatory Pathway
Incyte anticipates submitting a supplemental biologics license application (sBLA) to the FDA by the end of the year, seeking approval for tafasitamab in patients with follicular lymphoma who have failed at least one prior systemic anti-CD20 immunotherapy or chemoimmunotherapy. This regulatory submission could potentially expand the availability of tafasitamab to a broader patient population with follicular lymphoma, addressing an unmet medical need in those who have exhausted other treatment options.
Implications for Clinical Practice
The results of the inMIND trial suggest that the tafasitamab regimen could become a valuable addition to the treatment armamentarium for relapsed or refractory follicular lymphoma. The improved PFS observed in the trial highlights the potential of this combination therapy to provide durable disease control and improve outcomes for patients with this challenging malignancy. Further studies and real-world data will be important to fully characterize the long-term benefits and optimal use of tafasitamab in this setting.
