2023-04-20 08:10:57 ET
Novartis ( NYSE: NVS ) and BeiGene's ( NASDAQ: BGNE ) tislelizumab met the main goal of overall survival (OS) in a phase 3 trial in patients with a type of gastric cancer.
The phase 3 study, dubbed RATIONALE 305, evaluated tislelizumab in combination with platinum and fluoropyrimidine chemotherapy, versus placebo with the chemo, as a first-line treatment for patients with advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, regardless of PD-L1 status. A total of 997 patients were enrolled in the trial.
GEJ is a type of cancer of the esophagus, a tube which connects the mouth and stomach.
The company said that at the final analysis, the tislelizumab combo showed superior OS versus the placebo chemo in the intent-to-treat (ITT) population.
BeiGene had previously reported superior OS for the combination compared with chemotherapy in the PD-L1 high group at an interim analysis.
In patients with high PD-L1 expression, median OS was 17.2 months for tislelizumab combo, compared to 12.6 months for the placebo chemo.
The company noted that no new safety signals were seen for tislelizumab.
"At the recent ASCO GI meeting, we presented results from an interim analysis demonstrating a statistically significant and clinically meaningful improvement in overall survival in the high PD-L1 expression group in RATIONALE 305 and we are pleased that the final analysis demonstrated a significant survival benefit and consistent safety profile in the entire study population," said Mark Lanasa, chief medical officer, Solid Tumors at BeiGene.
Tislelizumab is currently under review in the U.S. and the EU for advanced or metastatic esophageal squamous cell carcinoma after prior chemotherapy.
The drug is also under review in the EU to treat certain patients with non-small cell lung cancer. Meanwhile, tislelizumab is approved in 10 indications in China.
BGNE +0.39% to $259.50 premarket April 20
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Novartis, BeiGene tislelizumab meets main goal in gastric/esophagus cancer trial