On Wednesday, the European Commission approved BeiGene Ltd’s Tevimbra (tislelizumab) in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

In ESCC, the expanded indication is for Tevimbra in combination with platinum-based chemotherapy for the first-line treatment of adult patients with unresectable, locally advanced or metastatic cancer whose tumors express PD-L1 with a tumor area positivity (TAP) score ≥ 5%.

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In G/GEJ adenocarcinoma, the expanded indication is for Tevimbra in combination with platinum-and fluoropyrimidine-based chemotherapy for the first-line treatment of adult patients with HER2-negative locally advanced unresectable or metastatic cancer whose tumors express PD-L1 with a TAP score ≥ 5%.

In first-line ESCC, the extension of indication application was based on results from the Phase 3 RATIONALE-306 study.

The study met its primary endpoint, with first-line Tevimbra in combination with chemotherapy resulting in statistically significant and clinically meaningful overall survival (OS) benefit compared with placebo plus chemotherapy in the intent-to-treat population.

The median OS was 17.2 months for Tevimbra with chemotherapy versus 10.6 months for placebo plus chemotherapy, a 34% reduction in the risk of death.

Three-year OS in the PD-L1 ≥ 5% population was also substantially improved in favor of the Tevimbra arm (median 19.1 versus 10.0 months, respectively), demonstrating a 38% reduction in the risk of death.

The extension of indication application for first-line G/GEJ cancer was based on RATIONALE-305 Phase 3 trial results.

The study met its primary endpoint and demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit with a median OS of 15.0 months for patients treated with Tevimbra in combination with the investigator’s choice of chemotherapy compared to 12.9 months for patients treated with placebo plus chemotherapy, resulting in a 20% reduction in the risk of death.

In the PD-L1 ≥ 5% population, the median OS was 16.4 months for Tevimbra plus chemotherapy compared to 12.8 months for the placebo arm, representing a 29% reduction in the risk of death.

Price Action: BGNE stock is up 6.99% at $205.53 at last check Wednesday.

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