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 were not allowed to 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. Updated data with a median follow up of 35 months was published in July 2021 confirming the data of the primary analysis (Duell et al 2021).
The REAL-MIND study is a multicenter, observational study that will collect data on treatments and outcomes for patients in the US with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) who are starting second- or third-line therapy and are not receiving autologous stem cell transplant. Primary objective of the study is to describe treatment patterns of patients with R/R-DLBCL starting second- or third-line therapy and not receiving HD-ASCT in the US. Secondary objectives include description of physician-reported clinical outcomes (effectiveness and safety), patient-reported health related quality of life and healthcare resource utilization. Subgroup analyses by race and ethnicity category are planned for primary and secondary outcomes.
The randomized, double-arm, open-label, multicenter phase 2/3 B-MIND (bendamustine - MOR208 in DLBCL) study was initiated in 2016 and enrolled 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 after consultation with 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 was increased to 450.
FIRST-MIND is a Phase Ib, open-label, randomized study to assess safety and preliminary efficacy of Tafasitamab in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristin, prednison) or Tafasitamab plus Lenalidomide in addition to R-CHOP in patients with newly diagnosed Diffuse Large B-Cell Lymphoma (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. Preliminary data from the First-MIND study presented at scientific meetings in 2020 and 2021 indicated that tafasitamab plus lenalidomide in combination with R-CHOP did not show unexpected toxicities and that adding tafasitamab plus lenalidomide to R-CHOP did not impair the dosing of R-CHOP.
frontMIND is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL. Primary endpoint of the study is progression-free survival (PFS) as assessed by the investigator using the Lugano Response Criteria for Malignant Lymphoma. Secondary endpoints include event-free survival (EFS), overall survival (OS) and metabolic complete response (CR) and overall response rate (ORR)).
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 the Annual ASH Meeting.
The InMIND Study is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R follicular lymphoma (FL) Grade 1 to 3a or R/R marginal zone lymphoma (MZL). Primary endpoint of the study is progression-free survival (PFS) in patients with FL. Secondary endpoints include PFS in patients with FL and MZL, complete (CR) and overall response (ORR), duration of response (DoR) and minimal residual disease negativity rate. The InMIND study is sponsored by Incyte.
The topMIND Study is a single-arm, open-label, Phase 1b/2a, multicenter basket study evaluating safety, PK, and efficacy of tafasitamab and parsaclisib in patients with relapsed/refractory non-Hodgkin lymphoma (R/R NHL or chronic lymphocytic leukemia (CLL). Primary objectives of the study are safety, tolerability, and dose-limiting toxicities of the combination of tafasitamab + parsaclisib and its efficacy. Secondary objectives are PK of tafasitamab and its immunogenicity when administered in combination with parsaclisib. The topMIND study is sponsored by Incyte.
The MINDway Study is an open-label, multi-centre, phase Ib trial of tafasitamab combined with lenalidomide (LEN) to evaluate the safety and pharmacokinetics (PK) of a modified tafasitamab dosing regimen in adult patients with R/R DLBCL.