Xinhua News Agency, Beijing (Reporter Zhaohui Zhang) — On August 2, the latest announcement from the Center for Drug Evaluation of the National Medical Products Administration revealed that the innovative drug Englumafusp Alfa Injection, submitted by Roche, has received tacit approval for clinical trials. It is intended for the development of treatment for non-Hodgkin's lymphoma (NHL).
Public information shows that englumafusp alfa is a bispecific antibody-like fusion protein that can simultaneously target CD19 on B cells and 4-1BB on immune cells such as T cells, thereby triggering a strong co-stimulatory signal, enhancing and prolonging cell activity, and boosting anti-tumor activity.
In addition, englumafusp alfa provides strong co-stimulation to T cells through 4-1BB agonism in the presence of and strict dependence on T-cell receptor signaling and CD19 crosslinking. When used in combination with the CD20/CD3 T-cell-engaging bispecific antibody, it can further enhance the latter's anti-tumor activity.
Currently, researchers are evaluating the combination of englumafusp alfa and the CD20×CD3 bispecific antibody glofitamab in a Phase 1 clinical trial for the treatment of patients with relapsed/refractory non-Hodgkin lymphoma (r/r NHL).
Preliminary study data indicate that the combination therapy demonstrates favorable antitumor activity in aggressive r/r NHL patients, with the best overall response rate.（BoR）was 67.0%, with a complete response (CR) rate of 57.0%; for second-line treatment of r/r aggressive NHL patientsBoRwas 77.0%, with a CR rate of 77.0%. Additionally, the combination therapy demonstrated a safety profile and cytokine release syndrome incidence comparable to glocotuzumab monotherapy.
Glofitamab has been approved in China in November 2023 for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least two prior lines of systemic therapy.
Proofread by Wu Xingfa