BMS Submits Clinical Application for LAG-3 and PD-1 Bispecific Fixed-Dose Combination Therapy in China

Recently, the clinical trial application for a fixed-dose combination injection comprising Bristol-Myers Squibb’s LAG-3 monoclonal antibody relatlimab and PD-1 monoclonal antibody nivolumab (Opdivo) was accepted by the CDE.

LAG-3 (CD223) is an immune checkpoint receptor protein that downregulates T cell activity by binding to major histocompatibility complex II (MHC II) molecules. Additionally, LAG-3 can also enhance the suppressive activity of regulatory T cells (Tregs). Relatlimab inhibits LAG-3, thereby relieving T cell suppression and enhancing the host immune response.

Opdivo is a programmed death receptor-1 (PD-1) blocking antibody that binds to the PD-1 receptor, thereby blocking its binding to the PD-L1 and PD-L2 ligands, inhibitingTumorImmune escape. Therefore, the combination formulation of the two agents exerts a synergistic effect, restores the function of effector T cells, and simultaneously improves patient medication adherence.

On March 25 this year, Bristol-Myers Squibb announced that the fixed-dose combination therapy comprising relatlimab and Opdivo in the treatment of metastatic or unresectableMelanomaPhase II/III in Treatment-Naïve PatientsClinical TrialIn the study, compared with Opdivo monotherapy, the primary endpoint of progression-free survival (PFS) was met.

On March 10 this year, Merck also submitted a clinical trial application in China for a fixed-dose combination comprising the TIGIT monoclonal antibody vibostolimab and the PD-1 monoclonal antibody pembrolizumab. (BioonBioon.com）