Originally published by our sister publication Clinical Oncology News
By Clinical Oncology News Staff
The FDA has approved tislelizumab-jsgr (Tevimbra, BeiGene), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express programmed death ligand-1 (PD-L1) (≥1).
The additional indication is based on results from BeiGene’s RATIONALE-306 (ClinicalTrials.gov. Identifier: NCT03783442), a randomized, placebo-controlled, double-blind, global phase 3 study to evaluate the efficacy and safety of tislelizumab-jsgr in combination with platinum-containing chemotherapy as a first-line treatment in adult patients (n=649) with unresectable, locally advanced recurrent or metastatic ESCC. The study met its primary end point and demonstrated a statistically significant improvement in overall survival (OS) for adult patients randomized to tislelizumab-jsgr in combination with chemotherapy compared with placebo plus chemotherapy. Exploratory analyses indicated that the improvement in the intent-to-treat population was primarily attributed to the results observed in the subgroup of patients with a PD-L1 of at least 1. Analysis of OS in the PD-L1–positive (≥1) population (n=481) showed a median OS of 16.8 months for patients treated with tislelizumab-jsgr plus chemotherapy compared with 9.6 months for patients treated with placebo plus chemotherapy (hazard ratio, 0.66; 95% CI, 0.53-0.82), resulting in a 34% reduction in the risk for death. These results represent an unprecedented improvement in OS in first-line ESCC patients.
The safety of tislelizumab-jsgr in combination with chemotherapy was evaluated in the same global clinical trial, RATIONALE-306. The most frequent serious adverse reactions (≥2%) were pneumonia, dysphagia, diarrhea, fatigue and esophageal stenosis. The most common (≥20%) adverse reactions were anemia, fatigue, decreased appetite, nausea, constipation, decreased weight, diarrhea, peripheral sensory neuropathy, vomiting and stomatitis.
Tislelizumab-jsgr is also approved in the United States as monotherapy for the treatment of adult patients with unresectable or metastatic ESCC after prior systemic chemotherapy that did not include a PD-L1 inhibitor and in combination with chemotherapy for the first-line treatment of adults with gastric and gastroesophageal junction cancers.
For more information, please see the full prescribing information for the drug.
Based on a press release from BeiGene.