BeiGene ( NASDAQ: BGNE ) and Novartis ( NYSE: NVS ) said tislelizumab plus chemotherapy helped improve overall (OS) survival in certain patients with esophageal cancer in a late-stage study.
Data from the phase 3 trial, dubbed RATIONALE 306, showed tislelizumab plus chemotherapy showed a median OS of 17.2 months, compared to 10.6 months for patients receiving chemotherapy plus placebo, and reduced the risk of death by 34%, said the companies.
The trial evaluated the drug combo in adult patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) without prior systemic treatment for advanced disease.
The companies noted that the OS benefit for the combo was seen regardless of baseline PD-L1 expression in the patients.
In patients with PD-L1 score ?10% (secondary goal of the study), tislelizumab/chemo showed a median OS of 16.6 months versus 10 months for patients on chemo/placebo, and reduced risk of death by 38%, according to the June 30 press releases.
The drug combo also improved the length of time a patient lives with the disease without it getting worse, also known as progression-free survival, to 7.3 months, compared to 5.6 months for the placebo/chemo combo.
The companies said the incidence of treatment-related adverse events (TRAEs) was similar in both groups and the most commonly reported TRAEs (? 20%) included anemia, decreased neutrophils and white blood cells and peripheral sensory neuropathy (damage to nerves outside the brain and spinal cord).
Novartis ( NVS ) plans to discuss results of the trial with regulatory authorities.
Tislelizumab is currently under review in the the U.S. and EU for advanced or metastatic ESCC after prior chemotherapy.
The drug is approved in China for nine indications.
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Novartis, BeiGene tislelizumab/chemo improves survival of esophageal cancer patients in trial