The Food and Drug Administration (FDA) has approved Tevimbra (tislelizumab-jsgr) in combination with platinum and fluoropyrimidine-based chemotherapy as a first-line treatment for adults with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) whose tumors express PD-L1 (≥1).
The approval was based on findings of the phase 3 RATIONALE-305 trial, which demonstrated a median overall survival (OS) time of 15 months for patients treated with Tevimbra in combination with investigator’s choice of chemotherapy versus 12.9 months for patients treated with placebo plus chemotherapy, a 20% reduction in the risk of death, according to a news release from manufacturer BeiGene.
Safety data included 1,972 patients who were treated with Tevimbra in seven studies, with the most common grade 3 (severe) or 4 (life-threatening) side effects to Tevimbra in combination with chemotherapy being neutropenia, thrombocytopenia, anemia, fatigue, hypokalemia, hyponatremia, pneumonia, decreased appetite, rash, lymphopenia, increased alanine aminotransferase, increased aspartate aminotransferase, diarrhea, lung inflammation and hepatitis.
Earlier this year, the agency approved Tevimbra for the treatment of patients with unresectable, metastatic esophageal cancer.
“Today’s FDA approval of Tevimbra for the treatment of gastric or gastroesophageal junction cancers in PD-L1-positive adult patients marks a significant step forward in our mission to deliver transformative therapies to patients with cancer,” said Dr. Mark Lanasa, Chief Medical Officer, Solid Tumors at BeiGene, in the news release. “This is the second U.S. approval for Tevimbra this year, underscoring its potential to address critical needs in oncology.”
Tevimbra, according to the National Cancer Institute, is a type of monoclonal antibody and a type of immune checkpoint inhibitor that binds to a protein called PD-1, which is found on T cells, and blocking this protein may help the immune system to kill cancer cells.
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