Benzinga | Dec 7, 2020 07:35AM EST

MacroGenics Highlights Presentation Of Tebotelimab Data In Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma At 2020 ASH Annual Meeting Dec. 5-8

* 53.8% ORR in relapsed/refractory DLBCL patients

* Preliminary duration of response of up to 168 days observed, with six of seven ongoing responses as of cut-off date

ROCKVILLE, MD, Dec. 07, 2020 (GLOBE NEWSWIRE) --

MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced updated results from a dose expansion study of tebotelimab, an investigational, bispecific PD-1 ? LAG-3 DART(r) molecule, in patients with diffuse large B-cell lymphoma (DLBCL). The data were presented at the 62nd Annual Meeting of the American Society of Hematology (ASH) taking place December 5-8, 2020.

LAG-3 has been shown to be highly expressed in DLBCL and has emerged as a therapeutic target of interest in this population, while PD-1-targeted therapy has yielded modest efficacy. There remains significant unmet need for patients with relapsed/refractory (R/R) DLBCL.

In one of the tebotelimab monotherapy dose expansion cohorts, 20 DLBCL patients were enrolled, half of whom were CAR T cell therapy experienced. As of the October 23, 2020 data cut-off, there were 13 response-evaluable patients.

A preliminary objective response rate (ORR) of 53.8% (7 of 13 patients) was observed, including responses in five of seven CAR T cell-na?ve patients and in two of six CAR T cell experienced patients, the latter of whom both had complete responses. A preliminary duration of response of up to 168 days was observed, with six of seven ongoing responses as of the cut-off date. In the study, baseline LAG-3 expression appeared to associate with clinical response, with additional analyses ongoing.

Tebotelimab was generally well-tolerated among heavily pre-treated R/R DLBCL patients, with manageable infusion-related reactions and no evidence of tumor lysis syndrome. The most common TRAE was pyrexia, which occurred in three (15%) patients. A single Grade 3 TRAE of anemia was observed.

"Although early, the preliminary ORR observed in relapsed/refractory DLBCL patients treated with tebotelimab is promising," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. "Beyond our continued enrollment of patients in the combination study of tebotelimab in solid tumors, we look forward to presenting data from the full cohort of the 20 enrolled DLBCL patients, as well as potentially defining a future registration path for this DART molecule."