Work

Inmind: a Phase 3 Study of Tafasitamab + Lenalidomide and Rituximab Vs Placebo + Lenalidomide and Rituximab for Relapsed/refractory Follicular or Marginal Zone Lymphoma

Year: 2021

Type: article

Abstract: immunochemotherapy in pts with iNHL.Key eligibility criteria: adults with relapsed or refractory FL or MZL who received ≥1 prior lines of therapy which must have included an anti-CD20 antibody in combination with chemotherapy or lenalidomide (L); at least one bidimensionally measured lesion >1.5 cm; adequate bone marrow, renal and hepatic function; ECOG performance status score of 0 to 1. Key exclusion criteria: histologically confirmed diagnosis of FL grade 3b or transformed disease; administration of 2 prior immunochemotherapy regimens; prior PI3K inhibitor therapy; known lymphomatous involvement of the central nervous system.Subjects will be randomized 1:1 to receive R-zandelisib or immunochemotherapy (R-CHOP or R-B) and stratified by type and number of prior treatment regimens, histology, and duration of treatment-free interval after last therapy.Zandelisib will be given in a 28-day cycle comprising of daily dosing for 2 cycles followed by IS dosing on days 1-7 or each 28-day subsequent cycle for a duration of 2 years.Rituximab or immunochemotherapy will be given for a total of 6 cycles.Disease response will be assessed by an Independent Response Review Committee according to the modified Lugano Classification.Radiographic tumor assessment will be performed approximately every 12 weeks for the first 9 months, every 16 weeks for the next 12 months, and every 24 weeks thereafter.The primary efficacy endpoint is progression-free survival.The major secondary endpoints include ORR, complete response rate, overall survival, and safety.The trial will enroll approximately 534 pts in ∼200 sites globally and will begin enrollment in mid-2021 (NCT04745832).

Source: Hematological Oncology

DOI: 10.1002/hon.175_2880