BeiGene...today announced that the China National Medical Products Administration (NMPA) has approved BeiGene’s anti-PD-1 antibody tislelizumab as a second- or third-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)....The approval of tislelizumab was supported by clinical results from a randomized, open-label, global Phase 3 trial RATIONALE 303 (NCT03358875) comparing tislelizumab to docetaxel in the second- or third-line setting in patients with locally advanced or metastatic NSCLC who have progressed on prior platinum-based chemotherapy.

BeiGene, Ltd...today announced that the China National Medical Products Administration (NMPA) has granted its anti-PD-1 antibody tislelizumab approval for the first-line treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC)....The approval of tislelizumab for the first-line treatment of patients with advanced non-squamous NSCLC was supported by clinical results from a Phase 3 trial (NCT03663205) of tislelizumab in combination with pemetrexed and platinum chemotherapy (either carboplatin or cisplatin) in patients with stage IIIB or stage IV non-squamous NSCLC, compared to pemetrexed and platinum alone.

RATIONALE 303 demonstrated that, as 2 or 3L therapy in pts with advanced NSCLC, TIS was tolerable and prolonged OS by 5-7 mo with improved PFS and ORR vs TAX regardless of histology or PD-L1 expression.

In this open-label phase 3 study (NCT03663205), Chinese pts were randomized 2:1 to receive tislelizumab 200 mg + platinum (carboplatin AUC 5 or cisplatin 75 mg/m2) + pemetrexed 500 mg/m2, followed by maintenance tislelizumab + pemetrexed (Arm A); pts in Arm B received platinum + pemetrexed and maintenance pemetrexed. Tislelizumab plus chemotherapy was generally well tolerated and demonstrated antitumor activity in pts with nsq-NSCLC.