FDA Approves Tevimbra Combination for Gastric or Gastroesophageal Junction Cancers

Phase 3 trial results demonstrated Tevimbra plus chemotherapy significantly improved overall survival

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A drug called Tevimbra (tislelizumab-jsgr) has been approved for use with chemotherapy as first-line treatment of PD-L1 positive unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Tevimbra was approved earlier in 2024 to treat unresectable or metastatic esophageal squamous cell carcinoma.

This treatment combination is for adults whose cancer:

  • Is locally advanced and can’t be surgically removed, or has spread to other parts of the body
  • Is HER2-negative
  • Tests positive for PD-L1

How It Works

Tevimbra is a type of precision cancer medicine. This humanized IgG4 anti-PD-1 monoclonal antibody was designed specifically to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

Study Results

In a large study of 1,657 patients, those who received TEVIMBRA plus chemotherapy lived longer than those who received only chemotherapy. On average, patients who got the combination treatment lived for 15 months, while those who got just chemotherapy lived for 12.9 months. This means the new treatment reduced the risk of dying by 20%.

From a pooled safety analysis of 1,972 patients who took TEVIMBRA, the most common grade 3 or 4 adverse reactions included:

  • Low white blood cell count
  • Low platelet count
  • Anemia (low red blood cell count)
  • Extreme tiredness
  • Low potassium or sodium levels
  • Pneumonia
  • Loss of appetite
  • Skin rash
  • Liver problems
  • Diarrhea
  • Lung inflammation

More Reading

Gastric Cancer Resource Center

Diagnosed with Gastric Cancer: 10 Tips on How to Get The Most From Your Doctor

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Reference

Qiu MZ, Oh DY, Kato K, et al; RATIONALE-305 Investigators. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first line treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma: RATIONALE-305 randomised, double blind, phase 3 trial. BMJ. 2024 May 28;385:e078876. 

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