Astellas Announces Japan Approval of Vyloy (Zolbetuximab), the World’s First Claudin 18.2-Targeted Monoclonal Antibody for Advanced Gastric Cancer

3Month26Day, AstellasOfficial website announcement, under itsClaudin18.2AntibodyVYLOYApproved for marketing in Japan, for the treatment ofUnresectable,AdvancedOr RecurrentStomach CancerPatient`, becoming the world's first`Approved for MarketingClaudin18.2Antibody.

Zolbetuximab(Product NameVYLOY)Is the first targetedClaudin18.2Monoclonal antibody, belonging to chimeric human-mouseIgG1Monoclonal antibodies induce tumor cell apoptosis by stimulating cellular immune effects and soluble immune effects, activating antibody-dependent cellular cytotoxicity and complement-dependent cellular cytotoxicity.

This approvalMainly based onSPOTLIGHTAndGLOWTwo itemsIIIPhase Research.

SPOTLIGHTResearch:A global, multicenter, randomized, double-blind, placebo-controlled Phase III study aimed at evaluatingzolbetuximab+mFOLFOX6First-line TreatmentClaudin18.2Positive,HER2Negative locally advanced unresectable or metastaticG/GEJEfficacy and safety in patients with adenocarcinoma. The results showed,zolbetuximab+mFOLFOX6Group vs. Placebo+mFOLFOX6Group'sPFSAndOSBoth showed a statistically significant improvement. MedianPFSRespectively10.61Months and8.67Months, MedianOSRespectively18.23Months and15.54Months.

GLOWResearch:A global, randomized, double-blind, Phase III study aimed to evaluatezolbetuximab+CAPOXComparison of Regimens with Placebo+CAPOXFirst-line treatmentClaudin18.2Positive,HER2Negative locally advanced unresectable or metastatic gastric/Efficacy and Safety of Adenocarcinoma of the Gastroesophageal Junction. The results showed,zolbetuximab+CAPOXGroup vs. Placebo+CAPOXGroupPFSAndOSBoth showed statistically significant improvement. MedianPFSRespectively8.21Months and6.80Months, (HR=0.687，95%CI：0.544-0.866，P=0.0007), medianOSRespectively14.39Months and12.16Months, (HR=0.771，95%CI：0.615-0.965，P=0.0118）。

This Year1Month9Recently, the FDA did not approve due to unresolved defects in its third-party manufacturing plant.zolbetuximabThe listing application. ButFDANot yetzolbetuximabClinical Data(Including efficacy or safety)No concerns were raised, nor were additional clinical studies requested.

In addition,Astellas has also submitted to regulatory authorities around the world VYLOY The application is under review.。

 CLDN18.2R&D Landscape

Popular TargetsCLDN18.2, a very intense R&D environment has already taken shape both in China and abroad. Currently, developments have been made targetingCLDN 18.2Multiple immunotherapies for cancer treatment, includingMonoclonal antibodies, bispecific antibodies (BsAbs）、CAR-TCells andADCTherapy。

CLDN18.2As an important target for gastric cancer, it is a must-contest for pharmaceutical companies.CLDN18.2It is one of the few targets for monoclonal antibody drugs.CurrentlyIn China, Transcenta Holding, Mingji Biotech, and Ascletis PharmaClaudin18.2Antibodies successively initiate Phase III clinical trials;AsADCThe development is equally worth looking forward to,Currently, there are three companies globally that have initiated global Phase III clinical trials for Claudin18.2 ADC: IBI343 from Innovent Biologics is the world's first Claudin18.2 ADC new drug to enter Phase III clinical trials; recently, CMG901 from Connaught Bio and Le Pu Bio, as well as LM-302 from LianBio/Turning Point (BMS), have also announced their entry into Phase III clinical trials.

According to the statistics from the PharmaResearch team,Among which ADC drug type projectsThere is12 ProductsHas entered the clinical development stage.

Attachment:CurrentlyClaudin18.2 ADCR&D Landscape