China-Based Biotech BeiGene Scores FDA Approval For Tevimbra/Chemo Combo For Untreated Patients With Esophageal Cancer

Zinger Key Points

FDA approved Tevimbra plus chemo for first-line treatment of PD-L1-positive metastatic ESCC, showing a 34% reduced risk of death in trials.
In a Phase 3 study, Tevimbra plus chemo improved median overall survival to 16.8 months vs. 9.6 months for placebo.
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On Tuesday, BeiGene Ltd ONC announced FDA approval for Tevimbra (tislelizumab-jsgr), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1).

The additional indication is based on results from the RATIONALE-306 Phase 3 study.

BeiGene will soon be renamed BeOne Medicines.

Also Read: Why Is BeiGene Stock Trading Higher On Wednesday?

The study met its primary endpoint and demonstrated a statistically significant improvement in overall survival (OS) for adult patients randomized to Tevimbra in combination with chemotherapy compared to placebo plus chemo combo.

Exploratory analyses indicated that the improvement in the intent-to-treat (ITT) population was primarily attributed to the results observed in the subgroup of patients with PD-L1 ≥1.

Analysis of OS in the PD-L1 positive (≥1) population (n=481) showed a median OS of 16.8 months for patients treated with Tevimbra plus chemotherapy compared to 9.6 months for patients treated with placebo plus chemotherapy (HR: 0.66, [95% CI: 0.53, 0.82]), resulting in a 34% reduction in the risk of death. These results represent an unprecedented improvement in OS in first-line ESCC patients.

In December, the FDA approved Tevimbra, in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1.

The additional indication is based on results from the RATIONALE-305 Phase 3 trial.

The study met its primary endpoint and demonstrated a statistically significant and clinically meaningful 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.

Price Action: At the last check Tuesday, ONC stock was up 3.04% at $253 during the premarket session.

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