▎WuXiEdited by Kant Content Team
Today, Merck & Co., Inc. announced that its重磅PD-1 inhibitor Keytruda reached the primary endpoint in the Phase 3 clinical trial KEYNOTE-811. When used in combination with the anti-HER2 antibody trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive, unresectable locally advanced or metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma,Significantly prolong patients' overall survival (OS)Previously, the U.S. FDA had granted accelerated approval to Keytruda combination therapy for first-line treatment of these patients based on the objective response rate (ORR) and duration of response data from this trial.The positive data announced today is expected to support the conversion of accelerated approval into full approval.
The interim analysis results published last year in the prestigious medical journal The Lancet showed that this Keytruda combination therapy also met another primary endpoint of KEYNOTE-811, significantly prolonging patients' progression-free survival (PFS). At a median follow-up time of approximately 28 months,The PFS in the Keytruda combination therapy group was 10 months, compared to 8.1 months in the group receiving only trastuzumab and chemotherapy. Adding Keytruda reduced the risk of disease progression or death by 28% (HR=0.72, 95% CI: 0.60–0.87; p=0.0002).
The early symptoms of gastric cancer are mild, leading to the late detection of most cases. More than 70% of patients with gastric cancer are diagnosed at an advanced stage. The global cancer statistics data released this year show that,Gastric cancer is the fifth most common cancer globally and the fifth leading cause of cancer-related deaths.In 2022, nearly 1 million new gastric cancer patients were diagnosed, and more than 650,000 patients died from gastric cancer. In China, over 350,000 new gastric cancer cases were confirmed in 2022, with gastric cancer causing more than 260,000 deaths.
Keytruda is a PD-1 inhibitor developed by MSD, which can block the interaction between PD-1 and its ligands PD-L1 and PD-L2, releasing the inhibition of immune responses mediated by the PD-1 signaling pathway. This activates T lymphocytes that may affect both tumor cells and healthy cells, thereby enhancing the ability of the human immune system to detect and destroy cancer cells. Since it was first approved by the FDA in 2014 for the treatment of advanced melanoma,Keytruda has received FDA approval for the treatment of at least 16 types of cancer, as well as tumor-agnostic indications. In the field of gastric cancer, in addition to being used in combination with trastuzumab and chemotherapy for first-line treatment of HER2-positive gastric cancer, Keytruda in combination with chemotherapy has also received FDA approval as a first-line therapy for HER2-negative gastric cancer or GEJ adenocarcinoma.
Image Source: MSD Official WebsiteFurther expanding the indications for Keytruda remains one of MSD's key focuses in research and development. During the company’s Q1 2024 earnings call, MSD executives noted,Keytruda in combination with chemoradiotherapy (CRT) significantly improves newly diagnosedPatients with High-Risk Locally Advanced Cervical CancerOverall SurvivalIn addition, the supplemental Biologics License Application (sBLA) for Keytruda in the treatment of patients with primary advanced or recurrent endometrial cancer has been granted by the U.S. FDA.Priority Review Status, with the review results expected to be released in June this year.
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[1] Merck Q1 2024 Earnings. Retrieved May 1, 2024, from https://s21.q4cdn.com/488056881/files/doc_financials/2024/q1/Q1-2024-Merck-Earnings-Deck-FINAL.pdf[2] Merck Announces Phase 3 KEYNOTE-811 Trial Met Dual Primary Endpoint of Overall Survival (OS) as First-Line Treatment in Patients With HER2-Positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma. Retrieved May 1, 2024, from https://www.merck.com/news/merck-announces-phase-3-keynote-811-trial-met-dual-primary-endpoint-of-overall-survival-os-as-first-line-treatment-in-patients-with-her2-positive-advanced-gastric-or-gastroesophageal-junction-gej/[3] Janjigian et al., (2023). Pembrolizumab plus trastuzumab and chemotherapy for HER2-positive gastric or gastro-oesophageal junction adenocarcinoma: interim analyses from the phase 3 KEYNOTE-811 randomised placebo-controlled trial. The Lancet, DOI:https://doi.org/10.1016/S0140-6736(23)02033-0[4] Bray et al., (2024). Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians. https://doi.org/10.3322/caac.21834[5] Han et al., (2024). Cancer incidence and mortality in China, 2022. Journal of the National Cancer Center. https://doi.org/10.1016/j.jncc.2024.01.006Disclaimer: 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.
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