The approval for the first-line treatment of esophageal squamous cell carcinoma comes shortly after a label expansion for the drug in gastric and gastroesophageal cancers as BeiGene also pushes forward a pipeline of novel cancer therapies.
BeiGene scooped up another indication for its anti-PD-1 antibody Tevimbra on Monday, getting FDA approval, in combination with platinum chemotherapies, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1.
The new indication is backed by results from the company’s RATIONALE-306 Phase III trial, in which Tevimbra and chemotherapy improved overall survival (OS) in adult patients with ESCC compared to patients on chemotherapy alone plus a placebo. The median OS in the treatment arm was 16.8 months and 9.6 months in the placebo arm.
Tevimbra was already registered in the U.S. as a second-line treatment for ESCC, according to BeiGene’s pipeline.
“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, BeiGene’s chief medical officer, said in a statement.
The safety evaluation in RATIONALE-306 reported adverse effects including pneumonia and dysphagia in a small proportion of patients, while more than 20% of patients suffered from anemia, fatigue and nausea.
The FDA greenlight comes on the heels of a different label expansion received in late 2024 for a few different forms of gastric or gastroesophageal carcinoma. The company is also testing Tevimbra in a variety of different cancers, including hepatocellular cancer, where a Phase III trial revealed positive data in 2022.
Tevimbra raked in $621 million for BeiGene last year, forming a significant chunk of the company’s $3.8 billion in total revenue, according to its earnings report released last Thursday.
The company is expecting an additional approval for first-line ESCC in Japan shortly, according to an analyst note from Leerink, and is evaluating Tevimbra in a Phase III HERIZON-GEA-01 trial for HER2-positive advanced or metastatic gastroesophageal adenocarcinoma in collaboration with Jazz Pharmaceuticals.
BeiGene’s pipeline is heavy with cancer treatments and includes Ociperlimab, an anti-TIGIT antibody for non-small-cell lung cancer, and BG-685011, a CDK2 inhibitor for solid tumors. BeiGene is also pushing into a new area for the company in the form of a pair of antibody-drug conjugates for a variety of solid tumors, both in Phase I trials.
The company announced in November 2024 its intention to rebrand to BeOne Medicines but is still operating as BeiGene as of this writing.
