BeiGene announced Thursday that its anti-PD-1 antibody tislelizumab gained approval from China's National Medical Products Administration to include use in combination with two chemotherapy regimens as a first-line treatment for patients with advanced squamous non-small-cell lung cancer (NSCLC). Xiaobin Wu, president of BeiGene, called the decision "an important milestone…and our first approval for tislelizumab in a lung cancer indication."
Tislelizumab was previously granted conditional approval by the NMPA to treat patients with classical Hodgkin's lymphoma and metastatic urothelial carcinoma. Meanwhile, filings are also under review in China seeking clearance of the drug, previously known as BGB-A317, for first-line treatment in advanced non-squamous NSCLC in combination with chemotherapy and for previously treated unresectable hepatocellular carcinoma.
The latest approval was supported by results from a Phase III study that investigated tislelizumab in combination with chemotherapy versus chemotherapy alone in 360 patients from mainland China with untreated stage IIIB or IV squamous NSCLC, regardless of PD-L1 expression. BeiGene announced last year that the trial, called BGB-A317-307, had met its primary endpoint of progression-free survival (PFS) at a planned interim analysis. Results later detailed at the American Society of Clinical Oncology (ASCO) annual meeting showed that median PFS was 7.6 months for patients who received tislelizumab compared to 5.5 months for chemotherapy alone.
The approval comes shortly after Novartis agreed to pay $650 million upfront to BeiGene to gain rights to tislelizumab in several major markets outside China, with the deal covering North America, the EU, the UK, Norway, Switzerland, Iceland, Liechtenstein, Russia and Japan. For related analysis, see ViewPoints: Novartis rejigs its PD-1 game with some help from BeiGene.
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