BeiGene/Ammunition CD3/DLL3 bispecific antibody filed for domestic market approval

Jul 17, 2025 10:09 CST Updated Sep 05, 10:47

July 16,The official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) shows,Tarlatamab developed through collaboration between BeiGene, Inc. and AmgenThe上市 application has been accepted. Previously, the drug was included in the priority review program, intended for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have failed at least two prior lines of therapy, including platinum-based chemotherapy.

Tarlatamab is a first-in-class CD3/DLL3 bispecific antibody developed by Amgen. It can simultaneously bind to the DLL3 protein on tumor cells and the CD3 protein on T cells, thereby activating T cells to kill tumor cells expressing DLL3 and inducing tumor cell lysis through the formation of cytolytic synapses. 85%–96% of SCLC patients have DLL3 protein expressed on the surface of their tumor cells, while normal cells express little to no DLL3 protein, making DLL3 a highly attractive therapeutic target.

In May 2024, based on the results of the DeLLphi-301 global Phase II clinical study, tarlatamab received accelerated approval from the U.S. FDA, becoming the first and currently the only approved DLL3/CD3 bispecific antibody and the first T-cell engager (BiTE) therapy for solid tumors. It is indicated for the treatment of adult patients with ES-SCLC who have failed platinum-based chemotherapy. Data showed that tarlatamab treatment (10 mg every two weeks, N=99) achieved an objective response rate (ORR) of 40%, a median duration of response (DoR) of 9.7 months, a median overall survival (mOS) of 14.3 months, with an overall manageable safety profile.

Recently, the interim analysis results from the global Phase 3 DeLLphi-304 clinical trial of tarlatamab were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The study enrolled patients with SCLC whose disease had progressed after first-line platinum-based chemotherapy. Data showed that tarlatamab achieved a median overall survival (mOS) of 13.6 months, significantly extending overall survival by 5.3 months compared to standard chemotherapy (8.3 months), with a 40% reduction in the risk of death (HR=0.60; P<0.001). Additionally, tarlatamab demonstrated a favorable safety profile during treatment, with a much lower incidence of grade 3 or higher treatment-related adverse events (TRAEs) compared to the chemotherapy group (27% vs 62%).

Both studies have been published in The New England Journal of Medicine, providing high-level evidence-based medical evidence for the advancement of standard treatment for SCLC.

BeiGene, Inc. has established a global oncology strategic collaboration with Amgen to jointly advance its development and commercialization in China, including participation in the global DeLLphi-304 study and leading the DeLLphi–307 clinical trial of tarlatamab for Chinese patients in the third-line and later settings, both of which have achieved positive results to date. In addition, multiple clinical trials are ongoing, covering the full spectrum of SCLC treatment populations. Going forward, the two companies will continue to expand the application of tarlatamab and accelerate the submission and approval of additional indications.

SCLC is a highly aggressive and destructive malignant tumor, accounting for approximately 15% of all lung cancer cases worldwide, with about 70% of SCLC patients further diagnosed with ES-SCLC. The disease is characterized by rapid growth and a high tendency to metastasize. Currently, first-line treatment for SCLC remains platinum-based chemotherapy. However, most patients experience disease progression within six months, and treatment options after recurrence are very limited, with a median overall survival of only 8 to 10 months.