BeOne Medicines AG (NASDAQ:ONC) saw its stock rise 2.5% in pre-market trading after the European Medicines Agency (EMA) issued a favorable opinion on its cancer drug TEVIMBRA for early-stage lung cancer.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of TEVIMBRA (tislelizumab), combined with platinum-based chemotherapy, for adult patients with resectable non-small cell lung cancer (NSCLC) who face a high risk of recurrence. This endorsement is grounded in data from the Phase 3 RATIONALE-315 trial.
The clinical study demonstrated significant advantages for patients treated with TEVIMBRA. The regimen delivered a major pathologic response rate of 56.2%, vastly outperforming the 15.0% seen in the placebo group. Furthermore, 40.7% of patients receiving TEVIMBRA achieved a complete pathological response, compared to just 5.7% in the control cohort.
Additionally, the trial revealed a statistically significant boost in event-free survival (hazard ratio of 0.56) and a promising trend toward improved overall survival (hazard ratio of 0.62).
“TEVIMBRA is already approved in the EU across multiple NSCLC indications, the most prevalent form of lung cancer, and this positive CHMP opinion expands its potential to benefit patients earlier in their treatment course,” stated Mark Lanasa, Chief Medical Officer at BeOne.
The safety profile remained consistent with prior findings, with 72.1% of patients on TEVIMBRA experiencing grade 3 or higher treatment-related adverse events, compared to 66.4% in the placebo group.
TEVIMBRA currently holds EU approval for several cancer types, including various lung cancers, gastric cancer, esophageal cancer, and nasopharyngeal carcinoma.
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