The FDA has granted a breakthrough therapy designation to MOR208 (MorphoSys) in combination with lenalidomide (Revlimid, Celgene) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not eligible for high-dose chemotherapy and autologous stem-cell transplantation. MOR208, an investigational Fc-engineered monoclonal antibody directed against CD19, is in clinical development for blood cancer indications.
DLBCL is the most frequent type of malignant lymphoma worldwide and accounts for approximately 30% of all non-Hodgkin’s lymphomas. Between 30% and 40% of all patients with DLBCL either fail to respond to or show a relapse to initial therapy.
The FDA’s breakthrough therapy designation is based on preliminary data from the ongoing phase 2 L-MIND study (NCT02399085), which is evaluating the safety and efficacy of MOR208 in combination with lenalidomide in patients with R/R DLBCL who are ineligible for high-dose chemotherapy and autologous stem cell transplantation. Preliminary data based on 34 eligible patients, presented at the American Society of Clinical Oncology 2017 meeting, showed an objective response rate of 56% and a complete response rate of 32%.
MorphoSys is investigating MOR208 as a therapeutic option in B-cell malignancies in a number of ongoing combination trials. In addition to the phase 2 L-MIND trial, the phase 2/3 B-MIND study began in August 2016 and transitioned into its phase 3 pivotal part in June 2017 following a recommendation of the independent data monitoring committee based on the available data from the phase 2 initial safety evaluation.
The B-MIND study is designed to investigate MOR208 in combination with bendamustine in patients with R/R DLBCL who are not eligible for high-dose chemotherapy and autologous stem cell transplantation. The study will compare the combination with the anti-CD20 antibody rituximab (Rituxan, Genentech) combined with bendamustine. Furthermore, MOR208 is being clinically investigated in patients with R/R CLL after discontinuation of a prior Bruton tyrosine kinase inhibitor therapy (e.g., ibrutinib [Imbruvica, Pharmacyclics]) in combination with idelalisib (Zydelig, Gilead) or venetoclax (Venclexta, AbbVie).
Source: MorphoSys; October 23, 2017.