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The FDA approved tislelizumab (Tevimbra) for advanced/metastatic esophageal squamous cell carcinoma (ESCC) previously treated with chemotherapy, .

The approval stipulates use of the PD-1 inhibitor in adults with advanced ESCC following systemic therapy that did not include a PD-1/L1 inhibitor. The action makes ESCC the first approved indication for tislelizumab in the U.S., according to the drugmaker.

"Patients diagnosed with advanced or metastasized ESCC, the most common histologic subtype of esophageal cancer, often progress following initial therapy and are in need of new options," said Syma Iqbal, MD, of the University of Southern California Norris Comprehensive Cancer Center in Los Angeles, in the company's statement. "The RATIONALE 302 trial showed that patients with previously treated ESCC who received Tevimbra saw a clinically meaningful survival benefit, highlighting its potential as an important treatment option for these patients."

The multinational phase III RATIONALE 302 trial included 512 patients with advanced/metastatic ESCC that had progressed after first-line chemotherapy. Patients were randomized to tislelizumab or investigator's choice of chemotherapy. The primary endpoint was overall survival (OS) in all patients, and a key secondary endpoint was OS in the subgroup of patients with a PD-L1 total positivity score ≥10.

In the overall analysis, median OS improved from 6.3 months with chemotherapy to 8.6 months with tislelizumab, representing a 30% reduction in the survival hazard (95% CI 0.57-0.85). The most common adverse events (≥20% of patients) with tislelizumab were increased glucose, decreased hemoglobin, decreased lymphocytes, decreased sodium, decreased albumin, increased alkaline phosphatase, anemia, fatigue, increased liver enzymes, musculoskeletal pain, decreased weight, and cough.

According to the company statement, the FDA is reviewing applications for approval of tislelizumab as first-line treatment for locally advanced/metastatic ESCC and unresectable/metastatic gastric or gastroesophageal junction adenocarcinoma. The drug has also shown positive results in nasopharyngeal carcinoma and non-small cell lung cancer.

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