A German drugmaker has positive data on hand for its CD19-targeting monoclonal antibody in an aggressive form of lymphoma that it plans to take to the Food and Drug Administration by the end of this year.

MorphoSys – based in Planegg, near Munich – said the Phase II L-MIND study of tafasitamab, also known as MOR208, combined with Celgene’s Revlimid (lenalidomide) in diffuse large B-cell lymphoma, had met its primary endpoint. The overall response rate in the study was 60 percent, including a complete response rate – meaning percentage of patients whose disease disappeared entirely – of 43 percent. Although the study was not randomized, it also showed a median progression-free survival of 12.1 months and median duration of response of 21.7 months. Ultimately, DLBCL drugs are expected to show a benefit on the endpoint of overall survival in a randomized, controlled trial. The drug has a Breakthrough Therapy Designation from the FDA that it received in October 2017.

“The results from the primary analysis are very encouraging,” said L-MIND lead investigator Dr. Gilles Salles, who heads the hematology department at the University of Lyon in France. “We are particularly pleased to see such a high complete response rate and a prolonged response duration, which is unusual in this population of relapsed or refractory DLBCL.”

Patients in the study were mostly older and heavily pretreated, with a median of two prior lines of therapy and a median age of 72 – ranging from 41 to 87 – according to data presented at the American Society of Hematology meeting in December.

A bigger question is where the therapy will fit into the realm of other anti-CD19 treatments, particularly CAR-T cell therapies that target the same antigen. The CAR-Ts targeting CD19 approved for DLBCL are Gilead Sciences’ Yescarta (axicabtagene ciloleucel) and Novartis’ Kymriah (tisagenlecleucel). Celgene subsidiary Juno Therapeutics has another anti-CD19 CAR-T in development, lisocabtagene maraleucel. If patients have received CD19-targeting therapy, there is a risk their disease could relapse without the antigen, thereby making them ineligible for subsequent treatments targeting the antigen.

MorphoSys spokeswoman Julia Neugebauer said in a phone interview that there is not yet any data available to indicate whether patients in L-MIND have experienced CD19-negative relapse. However, she added that the patients in the study would mostly be too old and frail to receive CAR-Ts anyway. The L-MIND study excluded patients who had received prior CD19-targeting therapy.

In contrast with the characteristics of patients in L-MIND, patients in the study that led to Yescarta’s approval had a median age of 58 – ranging from 23 to 76 – and a median three prior therapies. Patients in the study that led to Kymriah’s DLBCL approval had similar characteristics.

The other FDA-approved therapy targeting CD19 is Amgen’s Blincyto (blinatumomab), though it is only approved for acute lymphoblastic leukemia, meaning any use in DLBCL would be off-label. Nevertheless, only about 10-15 percent of patients receiving Blincyto experience CD19-negative relapse, meaning the vast majority would remain candidates for CAR-Ts.

Photo: CGToolbox, Getty Images



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