June 30, 2022
Novartis presented new Phase 3 data of tislelizumab in patients with advanced esophageal cancer.
Novartis presented new data from the Phase III RATIONALE 306 trial, showing an improvement in overall survival by six months compared to chemotherapy. Novartis and Beigene have presented the data at the 2022 European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer.
The first-line treatment with tislelizumab plus chemotherapy showed an overall survival of 17.2 months compared to 10.36 months in patients on chemotherapy. The risk of death was reduced by 34%. In patients with a PD-L1 score ≥10%, the median overall survival in patients on tiselizumab plus chemotherapy was 16.6 months versus 10.0 months in patients receiving chemotherapy alone. In patients with a PD-L1 score of <10%, the median overall survival was 16.7 months in tiselizumab plus chemotherapy arm vs. 10.4 months in patients on chemotherapy alone.
A statistically significant benefit was demonstrated irrespective of PD-L1 status and consistent across all patient populations.
ESCC is one of the most common esophageal cancers; 604,000 new cases are estimated annually, and 544,000 deaths were reported in 2020 because of esophageal cancer.
Tislelizumab plus chemotherapy significantly improved OS in patients with advanced esophageal cancer
Novartis announced a significant improvement in the overall survival with tislelizumab plus chemotherapy in patients with advanced esophageal cancer.
The company announced the primary endpoint at the interim analysis of the RATIONALE 306 trial, in which tislelizumab plus chemotherapy significantly improved the overall survival compared to chemotherapy alone in patients with advanced, previously untreated, locally advanced recurrent, or metastatic esophageal squamous cell carcinoma (ESCC), irrespective of PD-L1 expression.
RATIONALE 306 (NCT03783442) is a Phase 3 clinical trial that enrolled 649 participants and randomized in the 1:1 to receive tislelizumab plus chemotherapy vs. chemotherapy alone. Overall survival was considered the primary endpoint.