L-MIND (lenalidomide - MOR208 in DLBCL) is a phase 2 single-arm, open-label, multicenter study of tafasitamab (MOR208) in combination with lenalidomide in approximately 80 patients with relapsed or refractory DLBCL after at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g. rituximab). Patients must not be candidates for high-dose chemotherapy and autologous stem cell transplantation. The study's primary endpoint is objective response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS), as well as an evaluation of the drug combination's safety and pharmacokinetic parameters of tafasitamab (MOR208). The data from the primary analysis of L-MIND were presented in June 2019.
The randomized, double-arm, open-label, multicenter phase 2/3 B-MIND (bendamustine - MOR208 in DLBCL) study was initiated in 2016 and is expected to enroll patients in up to 180 centers in Europe, Asia Pacific (APAC) and the USA. The trial enrolls patients with relapsed or refractory DLBCL, who have previously been treated with at least one and not more than three prior lines of therapy, including one anti-CD20 targeting therapy (e.g. the antibody rituximab). Patients must not be eligible for high-dose chemotherapy and autologous stem cell transplantation.
The phase 2 safety evaluation part of the study to assess the safety and tolerability of tafasitamab (MOR208) plus bendamustine vs. the rituximab plus bendamustine combination was completed in mid-2017. In June 2017, the study was transitioned into the pivotal phase 3 part. The primary endpoint of the study is progression-free survival (PFS). Secondary outcome measures will include objective response rate (ORR), duration of response (DoR), overall survival (OS), disease control rate (DCR), time to progression (TTP) as well as an evaluation of patients' quality of life (QoL). In Q1 2019, MorphoSys has implemented an amendment of the B-MIND study in agreement with the FDA, which adds a biomarker-based co-primary endpoint to the original study protocol. In November 2019, B-MIND passed a futulity analysis. Based on the recommendation from an independent data monitoring committee, the number of patients in the study will be increased to 450.
First-MIND is an open-label, randomized, multicenter phase 1b study to evaluate safety and preliminary efficacy of tafasitamab in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristin, prednison) as well as tafasitamab and lenalidomide in addition to R-CHOP in adult patients with newly diagnosed, previously untreated DLBCL. Patients enrolled in each arm will receive six cycles of treatment. The primary endpoint is the incidence and severity of treatment-emergent adverse events (AEs), key secondary endpoints are objective response rate (ORR) and PET-negative complete response (CR) rate at the end of treatment.
The COSMOS-Study (CLL patients assessed for ORR & Safety in MOR208 Study) is a single-arm, open-label, multicenter phase 2 combination trial of tafasitamab (MOR208) with either idelalisib or venetoclax in adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Patient enrolled must have been refractory or shown relapse or intolerance to a prior, most recent, therapy with a Bruton's Tyrosine Kinase (BTK) inhibitor (e.g. ibrutinib). The study primarily evaluates the safety of the drug combinations. In 2019, MorphoSys presented data of the primary analysis of the COSMOS trial at ASH.