March 4, 2025
New Treatment Option for ESCC Patients
The U.S. Food and Drug Administration (FDA) has approved TEVIMBRA® (tislelizumab-jsgr) in combination with platinum-containing chemotherapy. This approval is for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1%). The approval, announced on March 4, 2025, offers a new treatment option for this patient group.
Dr. Nataliya Uboha, Associate Professor at the University of Wisconsin Carbone Cancer Center, noted, “The approval of TEVIMBRA in combination with chemotherapy for adult patients with ESCC expands first-line treatment options for patients with this disease. There is a critical need for effective treatments of ESCC. TEVIMBRA has been shown to improve outcomes in this patient population.”
RATIONALE-306 Trial Results
The approval is supported by data from the RATIONALE-306 trial (NCT03783442), a randomized, placebo-controlled, double-blind, global Phase 3 study. The trial included 649 adult patients with unresectable, locally advanced recurrent, or metastatic ESCC. It assessed the efficacy and safety of TEVIMBRA combined with platinum-containing chemotherapy compared to placebo with chemotherapy.
Key Findings
The study met its primary endpoint, showing a statistically significant improvement in overall survival (OS) for patients receiving TEVIMBRA plus chemotherapy. In the PD-L1 ≥1 subgroup (n=481), the median OS was 16.8 months for those treated with TEVIMBRA plus chemotherapy. This is compared to 9.6 months for those receiving placebo plus chemotherapy (hazard ratio: 0.66, 95% CI: 0.53–0.82). This indicates a 34% reduction in the risk of death. Furthermore, exploratory analyses indicated that the OS improvement in the intent-to-treat (ITT) population was primarily driven by the PD-L1 ≥1 subgroup.
Safety Profile and Additional Approvals
Safety data from the RATIONALE-306 trial reported the most common adverse reactions (≥20%) as anemia, fatigue, decreased appetite, nausea, constipation, decreased weight, diarrhea, peripheral sensory neuropathy, vomiting, and stomatitis. Serious adverse reactions (≥2%) included pneumonia, dysphagia, diarrhea, fatigue, and esophageal stenosis.
TEVIMBRA has also been approved in the U.S. for second-line treatment of unresectable or metastatic ESCC as a monotherapy. This is after prior systemic chemotherapy not including a PD-(L)1 inhibitor. It is also approved in combination with chemotherapy for first-line treatment of adults with gastric and gastroesophageal junction (G/GEJ) cancers.
Additional Information
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Tags: TEVIMBRA, ESCC treatment, cancer research, oncology, FDA approval, medical innovation, clinical trials, PD-L1
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