Expert Interview
Examining the Phase 3 inMIND Study Results for Tafasitamab (Monjuvi) in Relapsed or Refractory Follicular Lymphoma from Incyte (INCY)
Ticker(s): INCYInstitution: Cleveland Clinic
- Director of the Lymphoid Malignancies Program, Staff Physician in the Cleveland Clinic Taussig Cancer Institute, & Associate Professor of Medicine of the Cleveland Clinic Lerner College of Medicine.
- Manages several hundred patients with lymphoma including several dozen CD30-positive Hodgkin lymphoma.
- Clinical and research focus is in chronic lymphocytic leukemia (CLL) and lymphoma; PIof multiple on-going clinical trials of new cancer treatments including novel cellular therapies and has published extensive research articles pertaining to these topics.
The inMIND study met its primary endpoint of PFS by investigator assessment in the FL population. How important is this result in the context of current treatment options for relapsed or refractory follicular lymphoma?
Added By: catalin_adminThe trial also met key secondary endpoints, including PFS in the overall population and the PET-complete response rate in the FDG-avid FL population. What do these outcomes suggest about the broader efficacy of tafasitamab in combination with lenalidomide and rituximab across different patient subgroups?
Both investigator assessments and blinded independent review indicated consistent PFS results. How does this alignment strengthen the reliability of the trial findings, and how often do you see this level of consistency in clinical studies?
Given the high relapse rate in FL and limited options for patients who progress after initial therapy, how does tafasitamab, when combined with lenalidomide and rituximab, address the unmet need for effective second-line or later treatments in this population?
Safety Profile and Clinical Tolerability:No new safety signals were observed with tafasitamab in the inMIND study. How do these findings compare to the known safety profile of tafasitamab, and what factors make it a viable long-term treatment option for patients with relapsed or refractory FL?
Incyte plans to file a supplemental Biologics License Application for tafasitamab based on these results. What are the key regulatory considerations in pursuing approval for this combination therapy, particularly in a setting where other therapies have had limited success?
Considering the results of this trial, do you see potential for further exploration of tafasitamab in other lymphoma subtypes or in combination with emerging agents? What might the future hold for expanding its indications?
With several therapeutic options available for relapsed/refractory FL, including CAR-T and bispecific antibodies, where does tafasitamab in combination with lenalidomide and rituximab fit in terms of clinical positioning and patient selection?
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