Stomach Cancer: Latest Developments

Short summaries of recently published approvals, licensing and reimbursement regulations in Turkey, and notable studies in stomach cancer. For general information about the disease, see the Stomach Cancer page.

• • FDA Approval
  • Gastric Cancer
  • 25 August 2026

  Zanidatamab combinations receive FDA approval in HER2-positive gastric and gastroesophageal junction cancer

  The FDA approved two first-line uses in HER2-positive, unresectable locally advanced or metastatic adenocarcinoma of the stomach, gastroesophageal junction and oesophagus: the triplet of zanidatamab, chemotherapy and tislelizumab (IHC 3+ or IHC 2+/ISH-positive) and the doublet of zanidatamab and chemotherapy (IHC 3+ only). In the three-arm HERIZON-GEA-01 trial, median overall survival was 26.4 months with the triplet combination and 19.2 months with trastuzumab and chemotherapy (hazard ratio 0.72). Median progression-free survival was 12.4 versus 8.1 months (hazard ratio 0.63). Zanidatamab is a bispecific antibody that binds to two separate regions of the HER2 receptor. Two diagnostic tests that determine HER2 status were also approved with the approval.

  Status in Turkey: The TİTCK list of licensed products dated 02.10.2026 contains no product with zanidatamab and tislelizumab.

  • Source:
  • FDA announcement (25 August 2026)
• • FDA Approval
  • Gastric Cancer
  • 25 November 2025

  Durvalumab receives FDA approval for perioperative use with FLOT chemotherapy in resectable gastric cancer

  The FDA approved durvalumab with FLOT chemotherapy before and after surgery, followed by durvalumab alone, in resectable gastric or gastroesophageal junction adenocarcinoma. The MATTERHORN trial enrolled 948 previously untreated patients with stage II–IVA disease. The hazard ratio for event-free survival was 0.71 and for overall survival 0.78; median event-free survival was 32.8 months in the placebo and FLOT arm, while it had not yet been reached in the durvalumab arm. The pathological complete response rate, meaning no viable tumour remaining in the surgical specimen, was 19.2% versus 7.2%. The trial was not designed to measure separately the contribution of durvalumab in the pre- and postoperative periods. Warnings include immune-mediated adverse reactions.

  Status in Turkey: Durvalumab is licensed in Turkey for other indications; the licence and reimbursement status of this perioperative gastric cancer use in Turkey has not yet been clarified.

  • Source:
  • FDA announcement (25 November 2025)
• • Promising Studies
  • Gastric Cancer
  • 31 May 2025

  Satri-cel, a Claudin18.2-targeted CAR-T therapy in advanced gastric cancer: randomised phase 2 results

  The randomised phase 2 CT041-ST-01 trial, conducted in China and published in The Lancet, compared the CAR-T cell therapy satri-cel with standard treatment chosen by the physician in patients with Claudin18.2-positive advanced gastric or gastroesophageal junction cancer resistant to at least two lines of treatment. In the 156-patient trial, median progression-free survival was 3.25 months with satri-cel and 1.77 months in the control group (hazard ratio 0.37). Adverse events were marked: grade 3 or higher adverse events occurred during treatment in 99% of patients receiving satri-cel. CAR-T therapy is prepared by reprogramming the patient’s own immune cells in the laboratory to recognise the tumour. There is no FDA approval for satri-cel; the treatment is investigational.

  Status in Turkey: The TİTCK list of licensed products dated 02.10.2026 contains no satri-cel; the treatment is investigational.

  • Source:
  • Qi C et al. Lancet 2025;405:2049-2060
  • PubMed 40460847

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The news on this page is for general information only; it is not a diagnosis or treatment recommendation. Whether a treatment is suitable for you is decided together with your physician after assessing the characteristics of your disease.