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The FDA approved Tevimbra with chemotherapy for adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1.
The FDA approved Tevimbra for use with chemotherapy for patients with unresectable or metastatic esophageal squamous cell carcinoma with a PD-L1 expression.
The Food and Drug Administration (FDA) has approved Tevimbra (tislelizumab-jsgr), in combination with platinum-containing chemotherapy, as a first-line treatment for adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1.
“The approval of Tevimbra in combination with chemotherapy for adult patients with ESCC expands first-line treatment options for patients with this disease,” said Dr. Nataliya Uboha, Associate Professor, University of Wisconsin, Carbone Cancer Center, in a news release issued by Tevimbra manufacturer BeiGene. “There is a critical need for effective treatments of ESCC, and Tevimbra has been shown to improve outcomes in this patient population.”
The approval was based on the results of the phase 3 RATIONALE-306 clinical trial evaluating Tevimbra plus chemotherapy in 649 patients with unresectable, locally advanced recurrent or metastatic ESCC. The study, according to the news release, displayed a statistically significant improvement in overall survival compared to placebo in combination with chemotherapy. Analysis in the PD-L1-positive population showed a median overall survival of 16.8 months among patients treated with Tevimbra versus 9.6 months for patients treated with placebo, resulting in a 34% reduction in the risk of death.
“[The] 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,” said Dr. Mark Lanasa, Chief Medical Officer, Solid Tumors at BeiGene.
Tevimbra was previously approved in March 2024 for adults with unresectable or metastatic ESCC that had been treated with prior systemic chemotherapy and not a PD-1 or PD-L1 inhibitor.
Overall survival: the length of time from diagnosis or treatment initiation when a patient with cancer is still alive.
Dysphagia: difficulty swallowing.
Esophageal stenosis: narrowing of the esophagus.
Peripheral sensory neuropathy: damage to nerves outside of the brain and spinal cord.
Stomatitis: Inflammation or sores in the mouth.
Tevimbra, according to the National Cancer Institute, is a type of monoclonal antibody and a type of immune checkpoint inhibitor. It binds to the protein PD-1 found on T cells, a type of immune cell, and by blocking this protein it may help a patient’s immune system kill cancer cells.
The safety of the treatment regimen was observed in RATIONALE-306, according to the news release, with the most frequent serious side effects observed in at least 2% of patients being pneumonia, dysphagia, diarrhea, fatigue and esophageal stenosis. The most common side effects, experienced by at least 20% of patients, were anemia, fatigue, decreased appetite, nausea, constipation, decreased weight, diarrhea, peripheral sensory neuropathy, vomiting and stomatitis.
In data presented at the 2025 ASCO Gastrointestinal Cancers Symposium, the depth of response rate among responders to Tevimbra plus chemotherapy was 62.1%. Over half (50.2%) of responders achieved a depth of response above 50% up to and including 80%; a depth of response above 30% up to and including 50% was observed in 29.8% of responders; and a depth of response greater than 80% up to and including 100% was observed in 20% of responders. Among these three depth-of-response groups, the median OS was 23.7 months, 16.1 months and 34.5 months, respectively.
Among responders, the median time to maximum response was 19 weeks. Maximum response was achieved within 14 weeks, after 14 weeks up to and including 28 weeks, and after 28 weeks in 32.7%, 34.6% and 32.7% of responders, respectively. The median OS for patients in these respective time to maximum response categories was 14.3 months, 17.4 months and 39.9 months. The median OS after maximum response was 12.6 months, 14.3 months and 24.8 months, respectively.
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