Express Pharma

Novartis’s tislelizumab phase-III trial data shows survival results in esophageal cancer

First-line tislelizumab plus chemotherapy showed median Overall Survival (OS) of 17.2 months versus 10.6 months for chemotherapy and reduced risk of death by 34 per cent in patients with advanced oesophageal squamous cell carcinoma 

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Novartis recently announced results from the phase-III Rationale 306 trial showing tislelizumab plus chemotherapy significantly improved the Overall Survival (OS) as a first-line treatment for adult patients with unresectable, locally advanced or metastatic Esophageal Squamous Cell Carcinoma (ESCC), regardless of PD-L1 status. Tislelizumab plus chemotherapy demonstrated a median OS of 17.2 months (CI, 15.8-20.1 months) versus 10.6 months (CI, 9.3-12.1 months) in patients receiving chemotherapy plus placebo and reduced the risk of death by 34 per cent (hazard ratio=0.66; CI, 0.54-0.80, p<0.0001). In collaboration with BeiGene, these data were presented during a late-breaking oral session at the 2022 European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer (Abstract #LBA-1), a company statement said.

In patients with PD-L1 score ≥10 per cent (secondary endpoint), tislelizumab plus chemotherapy showed a median OS of 16.6 months (CI, 15.3-24.4 months) versus 10.0 months (CI, 8.6-13.0 months) in patients receiving chemotherapy plus placebo and reduced risk of death by 38 per cent (HR=0.62; CI, 0.44-0.86, p=0.0020). In those with PD-L1 score <10 per cent (exploratory analysis), median OS with tislelizumab plus chemotherapy was 16.7 months (CI, 13.0-20.1 months) versus 10.4 months (CI, 9.1-13.0 months; HR=0.72; CI, 0.55-0.94). Survival benefit was consistent across all other subgroups, including race, geographical region and investigator choice of chemotherapy. Tislelizumab plus chemotherapy also significantly improved progression-free survival (7.3 months vs 5.6 months; HR=0.62; CI, 0.52-0.75, p<0.0001) and objective response rate (63.5% vs 42.4%; odds ratio=2.38, p<0.0001), the statement said.

It notified that the incidence of Treatment-Related Adverse Events (TRAEs) was similar in both arms. Most common TRAEs for tislelizumab plus chemotherapy versus chemotherapy were anemia (68% vs 61%), decreased neutrophils (78% vs 80%), decreased white blood cell count (55% vs 65%), decreased appetite (39% vs 38%), nausea (37% vs 42%) and peripheral sensory neuropathy (26% vs 21%).

Rationale 306 (NCT03783442) is a multi-regional phase-III, randomised, placebo-controlled, double-blind study of tislelizumab in combination with chemotherapy versus chemotherapy in patients with unresectable, locally advanced recurrent or metastatic ESCC. Approximately, 649 study participants were randomised 1:1 to receive either tislelizumab plus chemotherapy or chemotherapy plus placebo. The primary endpoint is OS in the all-comer intent-to-treat population. Secondary endpoints include OS in patients with PD-L1 score ≥10 per cent, progression-free survival, objective response rate, duration of response, health-related quality of life measures and safety.

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