NEW YORK – BeiGene on Tuesday said the US Food and Drug Administration approved its anti-PD-1 monoclonal antibody Tevimbra (tislelizumab) with platinum-containing chemotherapy as a first-line treatment for unresectable or metastatic PD-L1-positive esophageal squamous cell carcinoma (ESCC).
The agency based its decision on results from the Phase III RATIONALE-306 trial, in which patients with PD-L1 total area positivity (TAP) scores of 1 or more on Tevimbra plus chemotherapy had a median overall survival of 16.8 months compared to 9.6 months on placebo plus chemotherapy, representing a 34 percent reduction in the risk of death. The most common adverse events patients experienced included anemia, fatigue, nausea, and diarrhea. Serious adverse events occurred among 2 percent or fewer patients in the trial. Those events included pneumonia, difficulty swallowing, diarrhea, fatigue, and esophageal stenosis.
"FDA approval of Tevimbra for the first-line treatment of advanced esophageal squamous cell carcinoma marks a significant step forward in tackling the unmet needs in this challenging disease area," Mark Lanasa, chief medical officer for solid tumors at BeiGene, said in a statement.
In September 2024, the FDA's Oncologic Drugs Advisory Committee determined that there was insufficient evidence to support first-line use of Tevimbra and two other checkpoint inhibitors, Merck's Keytruda (pembrolizumab) and Bristol Myers Squibb's Opdivo (nivolumab) in gastric and esophageal cancers with low or no PD-L1 expression.
Tevimbra monotherapy is currently available in the US as a first-line option for patients with unresectable or metastatic esophageal squamous cell carcinoma, regardless of their PD-L1 expression status, after they've received systemic chemotherapy without a PD-L1 or PD-1 inhibitor. Tevimbra plus chemotherapy is also an option in the US for first-line treatment of advanced gastric and gastroesophageal cancers that are HER2-negative but have a PD-L1 TAP score of at least 1 percent
In November 2024, the European Commission approved Tevimbra with chemotherapy in patients with gastric and esophageal junction cancer whose tumors express PD-L1 with a TAP score of 5 percent or more.