Incyte says Phase 3 inMIND trial met primary endpoint of PFS

Incyte (INCY) announced additional results from the pivotal Phase 3 inMIND trial evaluating treatment with tafasitamab, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in combination with lenalidomide and rituximab compared with placebo plus lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma. These data are featured today in the Late-breaking Session at the 2024 American Society of Hematology Annual Meeting in San Diego. The late-breaking results, which build on previously announced topline data, show that the study met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in progression-free survival by investigator assessment in 548 patients with FL. Patients treated with tafasitamab achieved a median PFS by investigator assessment of 22.4 months compared to 13.9 months in the control arm; Pless than0.0001, representing a 57% reduction in risk of progression, relapse, or death. The PFS assessed by an Independent Review Committee was consistent with investigator-based results, with a HR of 0.41. Median PFS by IRC was not reached in the tafasitamab group versus 16.0 months in the control arm. The PFS benefit was consistent across all patient subgroups regardless of the number of previous lines of therapy. The trial also showed improvement across secondary endpoints, including: Complete response, overall response rate and duration of response each showed improvement in the tafasitamab group versus the control arm and, respectively; ORR of 83.5% vs. 72.4%; Median overall survival was not reached in either group, but a positive trend was observed with the tafasitamab group versus the control arm.