▎WuXiEdited by Kant Content Team
Recently, MSD announced several significant advances in the PD-1 inhibitor Keytruda at the European Society for Medical Oncology (ESMO) Congress. Among them, an interim analysis of a phase 3 clinical trial showed that Keytruda, in combination with Lenvima, an orally administered multi-targeted receptor tyrosine kinase inhibitor (TKI) developed by Eisai, and transarterial chemoembolization (TACE), demonstrated efficacy in treating patients with unresectable, non-metastatic hepatocellular carcinoma (HCC).Compared with TACE alone, the combination of Keytruda/Lenvima plus TACE significantly improved progression-free survival (PFS) in patients.
At a median follow-up time of 25.6 months,Compared with TACE alone, the combination therapy group reduced the risk of disease progression or death by 34% (HR=0.66, 95% CI, 0.51-0.84, p=0.0002). The median PFS in the combination therapy group was 14.6 months (95% CI, 12.6-16.7), compared to 10.0 months (95% CI, 8.1-12.2) in the TACE alone group.In this analysis, the combination therapy group showed an improvement trend in overall survival (OS), another primary endpoint of the trial (HR=0.80, 95% CI, 0.57-1.11, p=0.0867). However, the OS data is not yet mature and did not reach statistical significance in this interim analysis. The trial is ongoing, and follow-up for OS is continuing.In addition, MSD also announced the final analysis results of the Phase 3 clinical trial KEYNOTE-811, which evaluatedEfficacy of Keytruda in Combination with Trastuzumab, Fluoropyrimidine, and Platinum-based Chemotherapy as First-line Treatment for Locally Advanced Unresectable or Metastatic HER2-positive Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.These data were also published simultaneously in The New England Journal of Medicine.
▲Overall Survival Analysis Results of Phase 3 Clinical Trial KEYNOTE-811 (Image Source: Reference [3])
At a median follow-up time of 50.2 months, the Keytruda combination therapy significantly improved patients' overall survival (OS).Compared with using trastuzumab and chemotherapy alone, the addition of Keytruda reduced the risk of death by 20% (HR=0.80, 95% CI, 0.67-0.94, p=0.0040).The median OS for patients receiving Keytruda combination therapy was 20.0 months (95% CI, 17.8-22.1), compared to 16.8 months (95% CI, 14.9-18.7) for those receiving trastuzumab plus chemotherapy.
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[1] KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) in Combination With Transarterial Chemoembolization Significantly Improved Progression-Free Survival Compared to TACE Alone in Patients With Unresectable, Non-Metastatic Hepatocellular Carcinoma. Retrieved September 16, 2024, from https://www.merck.com/news/keytruda-pembrolizumab-plus-lenvima-lenvatinib-in-combination-with-transarterial-chemoembolization-significantly-improved-progression-free-survival-compared-to-tace-alone-in-patients-w/[2] KEYTRUDA® (pembrolizumab) Plus Trastuzumab and Chemotherapy Significantly Improved Overall Survival (OS) Versus Trastuzumab and Chemotherapy Alone in First-Line Treatment of Patients With HER2-Positive Advanced Gastric or GEJ Adenocarcinoma. Retrieved September 16, 2024, from https://www.merck.com/news/keytruda-pembrolizumab-plus-trastuzumab-and-chemotherapy-significantly-improved-overall-survival-os-versus-trastuzumab-and-chemotherapy-alone-in-first-line-treatment-of-patients-with-her2-po/、[3] Janjigian et al., (2024). Pembrolizumab in HER2-Positive Gastric Cancer. NEJM, doi: 10.1056/NEJMc2408121 Disclaimer: The content team of WuXi AppTec focuses on introducing the research progress in global biopharmaceuticals and health. This article is for information exchange only, and the views expressed in the article do not represent the position of WuXi AppTec, nor does it indicate that WuXi AppTec supports or opposes these views. This article is not a recommendation for treatment plans. For guidance on treatment options, please visit a正规 hospital.Copyright Statement: This article is from the content team of WuXi AppTec. Individuals are welcome to share it on their social media platforms, but unauthorized reproduction by media or institutions in any form on other platforms is prohibited. For authorization to reproduce, please reply with "reprint" on the WeChat Official Account of "WuXi AppTec" to obtain reprint guidelines.
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