The European Commission approved BeOne's PD-1 inhibitor Tevimbra (tislelizumab) on 10 July for first-line treatment of recurrent/metastatic nasopharyngeal carcinoma (NPC) in combination with chemotherapy, marking its second EU approval this year. The decision was based on Phase III RATIONALE-309 trial data (n=263), where tislelizumab reduced disease progression or death risk by 48% versus chemotherapy alone, extending median progression-free survival (mPFS) to 9.2 months (vs 7.4 months) and overall survival to 45.3 months (vs 31.8 months).

Tislelizumab has now gained six EU indications across gastric, oesophageal and lung cancers. Global clinical programs span 35 countries with 21 registrational studies. The therapy was developed through BeOne's 2021 USD 650 million partnership with Novartis, which holds ex-China rights. Safety data from 3,900+ patients showed grade ≥3 adverse events like neutropenia (≥10%) were consistent with PD-1 class effects.

Source:
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