The U.S. Food and Drug Administration has granted breakthrough therapy designation to MorphoSys‘ MOR208 – in combination with Revlimid (lenalidomide) – for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), who are ineligible for other therapies, including high-dose chemotherapy and autologous stem cell transplant.
The designation is meant to accelerate the development of drugs that may significantly improve the outcome of patients suffering from serious or life-threatening diseases, compared to existing therapies.
“DLBCL is a very aggressive lymphoma. In particular, those patients who fail standard treatments are in need of more therapeutic options. We look forward to working closely with the FDA and to develop MOR208 as a potential new treatment option for these patients as quickly as possible,” Malte Peters, MD, chief development officer of MorphoSys, said in a press release.
MOR208 is an antibody targeting CD19, a protein that is highly abundant at the surface of B-cells. This makes CD19 an ideal target for the treatment of B-cell cancers.
The FDA’s decision was supported by data from the ongoing Phase 2 L-MIND study (NCT02399085), which is evaluating the safety and effectiveness of MOR208 plus Revlimid in patients with relapsed or refractory DLBCL, who are ineligible for high-dose chemotherapy or autologous stem cell transplant. Participants had received at least one, but no more than three, prior lines of therapy, including a CD20-targeted therapy like Rituxan (rituximab).
Preliminary data, presented during the 2017 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illionois, revealed that of the first 34 patients enrolled in the study, 19, or 56 percent, responded to the treatment, including 11 patients (32 percent) who experienced a complete response.
The presentation was titled, “L-MIND: MOR208 combined with lenalidomide (LEN) in patients with relapsed or refractory diffuse large B-cell lymphoma (R-R DLBCL) – A single-arm phase 2 study.”
“For MorphoSys, relapsed/refractory DLBCL is a key development focus. We expect to report further data from our ongoing phase 2 L-MIND trial with MOR208 plus lenalidomide at this year’s American Society of Hematology conference in December,” said Peters. “In addition, we are currently evaluating MOR208 in combination with bendamustine in our phase 3 B-MIND trial. MorphoSys intends to speed up and potentially broaden the development of MOR208 in other indications of unmet need.”