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Novartis Says Tislelizumab Met Primary Endpoint Of OS In Pivotal Phase III Trial - Quick Facts

Novartis AG (NVS) announced Friday results from the pivotal Phase III RATIONALE 302 trial showing the investigational anti-PD-1 immune checkpoint inhibitor tislelizumab improved overall survival (OS) versus chemotherapy.

The study evaluated tislelizumab in patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who had received prior systemic therapy. Results were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

Results from RATIONALE 302 in ESCC showed tislelizumab extended median OS by 2.3 months compared to chemotherapy with a 30% reduction in the risk of death. In PD-L1 positive patients, tislelizumab extended median OS by 3.5 months with a 46% reduction in the risk of death.

The data shows that tislelizumab has the potential to help patients with esophageal squamous cell carcinoma, one of the deadliest types of cancers, live longer.

Treatment with tislelizumab demonstrated median progression-free survival (PFS) of 1.6 months compared to 2.1 months. Tislelizumab also demonstrated a higher and more durable anti-tumor activity than chemotherapy of 7.1 months compared to 4.0 months.

ESCC is the most common type of esophageal cancer globally and the sixth leading cause of cancer-related death worldwide. More than two-thirds of patients with ESCC have advanced or metastatic disease at the time of diagnosis.

RATIONALE 302 is a randomized, global Phase III study assessing tislelizumab versus chemotherapy in patients with advanced unresectable/metastatic ESCC after prior systemic therapy.

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