The U.S. Food and Drug Administration (FDA) has granted approval for tislelizumab, in combination with chemotherapy, as a first-line treatment for adults with advanced gastric or gastroesophageal junction (G/GEJ) cancers that cannot be surgically removed or have spread, and whose tumors express PD-L1. This approval marks a significant milestone in expanding treatment options for patients facing these aggressive cancers.
The decision is backed by results from a global Phase 3 clinical trial, which demonstrated that tislelizumab, combined with platinum and fluoropyrimidine-based chemotherapy, significantly extended overall survival compared to chemotherapy alone.
The study showed a median overall survival of 15 months for patients receiving tislelizumab alongside chemotherapy, compared to 12.9 months for those on placebo and chemotherapy.
This translated to a 20% reduction in the risk of death, highlighting the potential of this combination therapy to improve patient outcomes.
Safety data included nearly 2,000 patients who participated in multiple clinical trials, covering both monotherapy and combination treatments. The most frequently observed severe side effects included low white blood cell counts, anemia, fatigue, electrolyte imbalances, pneumonia, decreased appetite, liver enzyme elevations, and inflammation of the lungs or liver.
Tislelizumab is also authorized in the U.S. as a standalone treatment for adults with advanced esophageal squamous cell carcinoma (ESCC) that has not responded to previous systemic chemotherapy lacking a PD-(L)1 inhibitor. A separate application is under FDA review for its use as a first-line treatment for patients with locally advanced or metastatic ESCC.
Gastric cancer remains the fifth most prevalent cancer globally and ranks as the fifth leading cause of cancer-related deaths. In 2022, around one million new cases were diagnosed worldwide, with approximately 660,000 deaths. In the United States, about 27,000 new cases and 11,000 deaths were projected for 2024. The five-year survival rate for gastric cancer in the U.S. stands at roughly 36%.
Gastroesophageal junction cancer, which affects the area where the esophagus meets the stomach, also poses significant health risks.
Tislelizumab is a humanized monoclonal antibody designed to block the PD-1 protein, enhancing the body’s immune response against tumors. Its structure minimizes interaction with macrophage receptors, allowing immune cells to more effectively target and destroy cancer cells.
This immunotherapy is a key component of the company’s oncology portfolio, with extensive clinical trials demonstrating its effectiveness across various cancer types. To date, nearly 14,000 patients across 34 countries have participated in tislelizumab trials, with the therapy receiving approval in over 42 countries.
Globally, more than 1.3 million patients have been treated with tislelizumab, reinforcing its role as a significant advancement in cancer treatment.
Comments