Regeneron's CD20xCD3 Bispecific Antibody REGN1979 Achieves Complete Responses in CAR-T Therapy-Failed Patients with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

On the 15th, Regeneron Pharmaceuticals announced at the 24th European Hematology Association (EHA) Congress that its bispecific antibody REGN1979 achieved positive results in early-stage clinical trials for treating patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL). Among two common subtypes of B-NHL patients, REGN1979 not only demonstrated a high complete response rate but also induced complete responses in patients who had failed CAR-T therapy.

B-NHL includes types such as diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). DLBCL is an aggressive form of B-NHL; up to 50% of patients with advanced-stage disease experience progression after first-line therapy. Treatment options for patients with relapsed or refractory (R/R) DLBCL are limited, and the prognosis is poor.

Follicular lymphoma (FL) is an indolent B-cell non-Hodgkin lymphoma (B-NHL). Although the median overall survival for patients with advanced-stage FL ranges from 8 to 15 years, current treatment options are not curative, and most patients experience disease relapse within five years after treatment. In some cases, FL can transform into diffuse large B-cell lymphoma (DLBCL).

REGN1979 is a bispecific antibody targeting CD20 and CD3, generated using Regeneron’s proprietary Veloci-Bi bispecific antibody platform. This technology platform enables the generation of full-length bispecific antibodies that resemble natural antibodies. These antibodies can be manufactured using standard antibody production technologies and exhibit pharmacokinetic properties similar to those of conventional antibodies. REGN1979 is designed to recruit T cells to the vicinity of CD20-expressing tumor cells by binding to the CD3 antigen on the surface of T cells, thereby facilitating the attack on tumor cells. It has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA).

Trial results published at EHA indicate:

In patients with grade 1–3a R/R FL, the overall response rate was 93% (13/14), with a complete response rate of 71%.

Among patients with R/R DLBCL, 2 out of 3 patients who had not previously received CAR-T therapy achieved complete remission; among 4 patients who had previously received anti-CD19 CAR-T therapy and experienced disease progression, 2 achieved complete remission.

“The high response rates observed with REGN1979 in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) are highly encouraging. These patients typically have a poor prognosis,” said Dr. Israel Lowy, Senior Vice President and Head of Clinical and Translational Science in Oncology at Regeneron. “In this study, two patients who had failed CAR-T therapy achieved complete remission. Currently, there are no approved therapies for this patient population whose disease progresses after CAR-T treatment. Our potential registrational Phase 2 clinical trial will be launched this month to evaluate the efficacy of REGN1979 in patients with indolent and aggressive non-Hodgkin lymphoma.”

References:

[1] Regeneron CD20xCD3 Bispecific REGN1979 Shows Positive Results in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma, including in CAR-T Failures. Retrieved June 14, 2019, from https://www.prnewswire.com/news-releases/regeneron-cd20xcd3-bispecific-regn1979-shows-positive-results-in-patients-with-relapsed-or-refractory-b-cell-non-hodgkin-lymphoma-including-in-car-t-failures-300867733.html

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