Regeneron presents positive data at for REGN1979 CD20xCD3 bispecific antibody

Regeneron Pharmaceuticals presented new data for REGN1979 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, including promising clinical results in follicular lymphoma and diffuse large B-cell lymphoma which are the two most common types of NHL. In this Phase 1 proof-of-concept trial, REGN1979 demonstrated an acceptable safety and tolerability profile with no observed dose-limiting toxicities. There were no clinically-significant neurotoxicities, including no occurence of seizures or encephalopathy. REGN1979 is a wholly-owned, investigational, full-length bispecific monoclonal antibody designed to trigger tumor killing by binding CD3 on immune system T-cells and CD20 on B-cell malignancies. In the data presented at the 2018 American Society of Hematology Annual Meeting, heavily pre-treated patients with R/R FL grades 1 to 3a who received REGN1979 doses of 5 mg to 40 mg, experienced a 100% overall response rate; 90% of responders maintained a response during treatment. Based on these data, Regeneron plans to initiate in 2019 a potentially registrational Phase 2 trial investigating REGN1979 in R/R FL. REGN1979 also showed encouraging dose-dependent clinical activity in heavily pre-treated patients with R/R DLBCL. Among patients receiving doses between 5 mg and 12 mg, the ORR was 18%. At doses of 18 mg to 40 mg, the ORR increased to 60%. Regeneron plans to continue dose-escalation in DLBCL. The objectives for this ongoing Phase 1 proof-of-concept trial are to assess safety, tolerability and efficacy of REGN1979 monotherapy. The data presented at ASH included a total of 68 patients with R/R B-NHL who were treated with REGN1979. These patients had received a median of three prior therapies, including an anti-CD20 therapy. As of September 2018, 14 patients had completed treatment, 13 patients remained on treatment and 41 had discontinued treatment. The most common reason for treatment discontinuation was progressive disease. Two patients discontinued treatment due to a treatment-emergent adverse event. In the trial, the most common TEAEs occurring in at least 25% of patients were pyrexia, chills, cytokine release syndrome, fatigue, increased C-reactive protein, anemia, hypotension, infusion-related reaction and nausea. IRR and CRS events were generally mild to moderate in severity, and neither resulted in trial discontinuations. Three patients in the trial died due to adverse events. Of these, one death, in a patient with a tumor involving the gastric lining who experienced a gastric perforation, was attributed to REGN1979.
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