Progress Made for Gastric Cancer with FDA Approval of Tevimbra

The FDA has approved Tevimbra (tislelizumab-jsgr) for a second indication: in combination with platinum and fluoropyrimidine-based chemotherapy as a first-line treatment for metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express the protein PD-L1.

Gastric cancer, commonly known as stomach cancer, is the fifth most common cancer globally and the fifth leading cause of cancer-related deaths, according to a release by BeiGene, the developer of Tevimbra.

In 2022 alone, nearly 1 million new cases were diagnosed worldwide, and the disease claimed 660,000 lives.

According to the American Cancer Society, there is an estimated 27,000 people in the United States who were diagnosed with gastric cancer in 2024, leading to approximately 11,000 deaths. The number of new cases of stomach cancer in the United States has been dropping by about 1.5% each year over the last 10 years.

This latest approval is the second for Tevimbra in 2024, as the drug was previously approved in the United States as a monotherapy for unresectable or metastatic esophageal squamous cell carcinoma (ESCC) in adults following prior systemic chemotherapy that excluded the PD-L1 inhibitor.

Temimbra launched in October 2024 at a price that company officials said was 10% lower than other anti-PD-1 therapies approved in this indication. At the time of launch, the average wholesale acquisition cost of Tevimbra was about $15,075 per month, according to media reports, but a company spokesperson told Managed Healthcare Executive that updated pricing will be available in a few weeks.

The recent approval for Tevimbra’s use in gastric cancers is based on data from BeiGene’s phase 3 trial that was designed to evaluate the efficacy and safety of the drug in combination with chemotherapy.

Data revealed that the overall survival was 15 months for patients treated with Tevimbra and chemotherapy, compared with 12.9 months for those receiving placebo and chemotherapy. The hazard ratio was 0.80, indicating a 20% reduction in the risk of death.

To better understand the drug’s safety, researchers analyzed data from 1,972 patients. Significant side effects that occurred when the treatment was combined with chemotherapy included issues with patient’s blood such as low white blood cells, low platelets and low red blood cells.

Other common side effects were fatigue, lung infections such as pneumonia, loss of appetite, skin rashes, liver problems, diarrhea and lung inflammation through pneumonitis.