A combination of MorphoSys‘ MOR208 and Revlimid (lenalidomide) eliminated cancer cells in almost a third of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), a Phase 2 clinical trial shows.
Tumor reduction was seen in 49% of patients, and half of patients showed no signs of the disease progressing a year after starting treatment, according to the preliminary results.
MOR208 is an experimental monoclonal antibody that targets CD19, a protein found on the surface of immune B-cells. It is a potential treatment for B-cell malignancies such as DLBCL, non-Hodgkin’s lymphoma (NHL), and chronic lymphocytic leukemia (CLL).
The Phase 2 L-MIND clinical trial (NCT02399085) is testing MOR208 as a treatment for patients with relapsed or refractory DLBCL who are ineligible for high-dose chemotherapy or stem cell transplants.
Researchers are evaluating its safety and effectiveness in combination with Revlimid, an immunomodulatory drug that the U.S. Food and Drug Administration has approved as a lymphoma treatment. In November 2017, the multicenter study completed enrollment with 81 patients in the United States and Europe who had already received up to three lines of treatment, including an anti-CD20-targeting therapy.
The most recent data was based on 68 patients who were available at the time of the analysis. The results confirm interim results reported in June 2017.
At a median time of 8.3 months, about 49% of the patients had responded to the therapy, with 31% showing a complete response, or no sign of cancer. Of these 33 patients, 29 were continuing to respond to the therapy at the data cut-off. Median time to response was 1.8 months, and median time to a complete response was 3.6 months.
At 12 months, half of patients’ cancer had not progressed.
No unexpected toxicities or infusion-related reactions were observed or reported. The most frequent adverse reactions were neutropenia (an abnormally low concentration of a type of white blood cell called neutrophils in the blood), in 36% of patients, and thrombocytopenia (abnormally low levels of thrombocytes, or platelets, in the blood), in 12% of patients.
“We are truly excited about this data and our productive discussions with FDA under the current breakthrough therapy designation on the path to market for MOR208, including the possibility of an expedited regulatory submission and approval for MOR208 based primarily on the L-MIND study. We look forward to continuing the analysis of maturing data from the L-MIND trial and to maintaining our interactions with the FDA,” Malte Peters, the chief development officer of MorphoSys, said in a press release.
The FDA granted MOR208 breakthrough therapy designation in October 2017 to accelerate its development as a potential treatment for DLBCL patients.
“There is a very high unmet medical need for patients with r/r DLBCL who, after having failed initial therapies, are ineligible for high-dose chemotherapy and autologous stem cell transplantation,” said Simon Moroney, the chief executive officer of MorphoSys. “We are very encouraged by our most recent clinical data from the ongoing L-MIND trial, which support our plan to develop MOR208 in combination with lenalidomide as a chemo-free treatment option for this patient population.”
