On November 16, MSD announcedKeytruda（PaboLizuzumab) Receives FDA Approval for New Indication, for Use in Combination with Chemotherapy as First-Line Treatment for Locally Advanced Unresectable or MetastaticHER2-negativeGastric cancer orGastroesophageal Junction (GEJ) Adenocarcinoma。The FDA's approval this time is mainly based on the positive data from the Phase III KEYNOTE-859 study. The study included a total of 1,579 patients and aimed to evaluateEfficacy and Safety of Keytruda in Combination with PF (5-Fluorouracil + Cisplatin) or CAPOX (Capecitabine + Oxaliplatin) versus Placebo in Combination with PF/CAPOX as First-Line Treatment for HER2-Negative Locally Advanced Unresectable or Metastatic Gastric or GEJ Adenocarcinoma Patients,The primary endpoint was overall survival (OS), and secondary endpoints included progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), etc.The study results showed that, in the overall population (regardless of PD-L1 expression status), after a median follow-up of 31.0 months (15.3-46.3 months),The median OS of patients in the Keytruda group was significantly longer compared to the chemotherapy group (12.9 vs. 11.5 months)., the risk of death was reduced by 22% (HR=0.78; 95% CI: 0.70-0.87; P<0.0001).An exploratory analysis of PD-L1 negative patients (CPS <1) revealed that,KeytrudaThe median OS was 12.7 months in the group and 12.2 months in the chemotherapy group, with an HR of 0.92.In terms of secondary endpoints,Median PFS in Keytruda-treated patients(6.9 vs. 5.6 months)）Median DOR was significantly prolonged (8.0 vs. 5.7 months), reducing the risk of disease progression or death by 24%.（HR=0.76；95% CI:0.67-0.85；P<0.0001)；The ORR in the Keytruda group was also higher than that in the placebo group (51.3% vs. 42.0%, P=0.00009).In summary, regardless of the patient's PD-L1 expression, the primary endpoint OS, secondary endpoints PFS and ORR all showed statistically significant improvement.SafetySexAspect,Keytruda Group Experienced Grade 3-5CureTherapeutic PhaseAdverse Event (TRAEs) was 59.4%, compared to 51.1% in the placebo group.Statistics show that the 5-year survival rate for patients with metastatic gastric cancer is only 6%, of which 80% are HER2-negative gastric cancer. The treatment needs of these patients are yet to be met.Copyright © 2023 PHARMCUBE. All Rights Reserved.
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