Merck's PD-1 Inhibitor Keytruda® Approved in China for Newly Indicated First-Line Treatment of Locally Advanced or Metastatic HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

On June 25, 2024, MSD announced that its PD-1 inhibitor Pembrolizumab (trade name: Keytruda)^®) has been approved by the China National Medical Products Administration (NMPA) in combination with trastuzumab, fluoropyrimidine-based, and platinum-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (Combined Positive Score (CPS) ≥1) as assessed by a validated test. The approval of this new indication is based on data from the global Phase III clinical trial KEYNOTE-811.

According to the latest data released by the WHO, China has about 358,000 new cases of gastric cancer annually and approximately 260,000 deaths.¹The vast majority of stomach cancers are adenocarcinomas, accounting for more than 95%.²In China, the proportion of early-stage gastric cancer patients is very low, accounting for only about 20%. Most patients are already in the advanced stage when diagnosed.³, while the five-year survival rate for advanced gastric cancer is less than 10%.⁴。

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References:
1.World Heath Organization, IARC, Globocan 2022. Cancer Today: China Fact Sheet
2. Ma Qianchen, Zhang Benyan, Rui Weiwei, Wang Ting, Luo Fangxiu, Wang Chaofu, Yuan Fei. Analysis of Pathological Types of 3,071 Cases of Gastric Cancer in China [J]. Journal of Diagnostics Theory and Practice, 2022, 21(05): 560-566.
3. Medical Administration Department of the National Health Commission of the People's Republic of China. (2022) Guidelines for Diagnosis and Treatment of Gastric Cancer http://www.nhc.gov.cn/yzygj/s7659/202204/a0e67177df1f439898683e1333957c74/files/dfc6063ce0a441a5b6d9c7350cac2c2a.pdf
4.Li H, Zhang H, Zhang H, Wang Y, Wang X, Hou H; Global Health Epidemiology Reference Group. Survival of gastric cancer in China from 2000 to 2022: A nationwide systematic review of hospital-based studies. J Glob Health. 2022 Dec 17;12:11014. doi: 10.7189/jogh.12.11014. PMID: 36527356; PMCID: PMC9759711.
5. Chinese Anti-Cancer Association Gastric Cancer Professional Committee, Chinese Anti-Cancer Association Tumor Endoscopy Professional Committee. Chinese Expert Consensus on HER-2 Testing in Gastric Cancer Gastroscopy Biopsy Specimens (2023 Edition) [J]. Chinese Journal of Clinical Oncology, 2023, 50(19): 973-982. doi: 10.12354/j.issn.1000-8179.2023.20230961
6.Huang D, Lu N, Fan Q, Sheng W, Bu H, Jin X, Li G, Liu Y, Li X, Sun W, Zhang H, Li X, Zhou Z, Yan M, Wang X, Sha W, Ji J, Cheng X, Zhou Z, Xu J, Du X. HER2 status in gastric and gastroesophageal junction cancer assessed by local and central laboratories: Chinese results of the HER-EAGLE study. PLoS One. 2013 Nov 14;8(11):e80290. doi: 10.1371/journal.pone.0080290. PMID: 24244671; PMCID: PMC3828190.
7.Sheng WQ, Huang D, Ying JM, Lu N, Wu HM, Liu YH, Liu JP, Bu H, Zhou XY, Du X. HER2 status in gastric cancers: a retrospective analysis from four Chinese representative clinical centers and assessment of its prognostic significance. Ann Oncol. 2013 Sep;24(9):2360-4. doi: 10.1093/annonc/mdt232. Epub 2013 Jun 19. PMID: 23788757.
8.Wang J, Sun N, Kunzke T, Shen J, Feuchtinger A, Wang Q, Meixner R, Gleut RL, Haffner I, Luber B, Lordick F, Walch A. Metabolic heterogeneity affects trastuzumab response and survival in HER2-positive advanced gastric cancer. Br J Cancer. 2024 Apr;130(6):1036-1045. doi: 10.1038/s41416-023-02559-6. Epub 2024 Jan 24. PMID: 38267634; PMCID: PMC10951255.
9.Kawakami T, Yamazaki K. Recent Progress in Treatment for HER2-Positive Advanced Gastric Cancer. Cancers (Basel). 2024 Apr 30;16(9):1747. doi: 10.3390/cancers16091747. PMID: 38730700; PMCID: PMC11083522.

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