Amgen and BeiGene Launch Phase 3 Clinical Trial of Tarlatamab in China for Limited-Stage Small Cell Lung Cancer

Mar 25, 2024 15:41 CST Updated 15:42

BeOne

Developer of Molecular Targeted and Immune Anti-Tumor Drugs

Amgen

Developer of Treatment Drugs for Serious Diseases

▎WuXi AppTec Content Team Report

China Drug Clinical Trial Registration and Information Disclosure Website recently disclosed,Amgen (Amgen) andBeOne Medicines jointly launched an international multicenter (including China) Phase 3 clinical trial (DeLLphi-306) to evaluateTreatment with Tarlatamab after Chemoradiotherapy for Limited-Stage Small Cell Lung CancerEfficacy and safety.

Public information shows that tarlatamab is aBispecific T-cell Engager (BiTE) Targeting DLL3 and CD3，BeOne Medicines has the commercial rights in China for this drug.Rights. Previously,The marketing application for this product to treat advanced small cell lung cancer (SCLC) has been granted by the U.S. FDA.Priority Review StatusAmgen stated in a press release that if approved, tarlatamab could become the first BiTE therapy for the treatment of solid tumors.

Screenshot source:China Drug Clinical Trial Registration and Information Disclosure Platform Official Website

Bispecific T-cell Engager (BiTE)It is a type of bispecific antibody that has drawn widespread attention in recent years. It utilizes both ends to connect two different types of cells, facilitating interaction between them. If one end binds to a receptor on the surface of T cells (such as CD3 or CD28) and the other end connects to tumor cells, it can help...Recruit T cells to the vicinity of tumor cells, thereby killing tumor cells.。

Public information shows that tarlatamab (AMG 757) is aBiTE Product Targeting DLL3 and CD3。Among them,DLL3(delta-like canonical Notch ligand 3) is expressed on the surface of tumor cells in approximately 85% of patients with small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma. It is also highly expressed in various cancer cells such as glioblastoma multiforme, melanoma, pancreatic cancer, and rectal cancer, but shows limited expression in healthy tissues. As a BiTE,Tarlatamab can recruit T cells to the vicinity of small cell lung cancer cells, activating T cells to kill tumor cells.In addition, the researchers also extended its half-life through engineering modifications.

The project launched in China this time is namedDeLLphi-306'sRandomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study, AimingInLimited-stage small cell lung cancer (LS-SCLC) without progression after concurrent chemoradiotherapyEvaluation of the efficacy and safety of treatment with tarlatamab in subjects.The principal investigator of this trial in China is Chief Physician Qian Chu from Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.

It is worth mentioning that, for the SCLC indication,The FDA has already2December 2023Submission for Biologics License Application of TarlatamabPlease (BLA) andGranted Priority Review Status,SpecificIndications areTreatment of adult patients with advanced small cell lung cancer (SCLC) whose disease has progressed during or after platinum-based chemotherapy.

This BLA is based on a global Phase 2 clinical trialTest DeLLphi-301 ResultsFruit.ResearchData shows,At a median follow-up of 10.6 months, an intent-to-treat analysis of 100 patients receiving the selected 10mg dose of tarlatamab showed an objective response rate (ORR) of 40%.For the key secondary endpoints, the median progression-free survival (PFS) was 4.9 months, and the median overall survival (OS) was 14.3 months.Among patients who responded to the 10mg dose of tarlatamab, 58% maintained their response for at least six months as of the data cutoff, and 55% of the responses were still ongoing.No new safety signals were observed compared to Phase 1 clinical trials.The StudyThe detailed data has been published in The New England Journal of Medicine (NEJM).

According to a recent press release from Amgen, in addition to the aforementioned DeLLphi-306 andDeLLphi-301Test，Researchers are also conducting multiple clinical research projects on tarlatamab, including:DeLLphi-302, a Phase 1b study, evaluates tarlatamab in combination with a PD-1 inhibitor for second-line or advanced SCLC treatment;DeLLphi-303, a Phase 1b study, investigating the combination therapy of tarlatamab with the standard-of-care treatment for first-line SCLC;DeLLphi-304, a Phase 3 clinical study comparing tarlatamab monotherapy with standard-of-care chemotherapy for second-line treatment of SCLC;DeLLpro-300, A Phase 1b Study of Tarlatamab in Treatment-Naïve or Treatment-Emergent Neuroendocrine Prostate Cancer. In addition,Amgen also plans to initiate another study for tarlatamab.First-line Treatment for SCLCPhase 3 study.

References:

[1] ChinaClinical Trial Registry and Information Disclosure Platform Official Website. Retrieved Mar 21, 2024. From http://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml

[2] BeOne Medicines Official Website. From https://www.beigene.com.cn/our-science-and-medicines/pipeline-2/

[3]FDA GRANTS PRIORITY REVIEW TO AMGEN'S TARLATAMAB APPLICATION FOR ADVANCED SMALL CELL LUNG CANCER. Retrieved Dec 13, 2023. From https://www.amgen.com/newsroom/press-releases/2023/12/fda-grants-priority-review-to-amgens-tarlatamab-application-for-advanced-small-cell-lung-cancer

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