Overall, 805 pts were randomized (n=535, TIS; n=270, TAX)...With a 19-mo median follow-up (441 OS events), median OS ITT was significantly longer in Arm A vs B (17.2 vs 11.9 mo; HR=0.64 [95% CI: 0.53, 0.78]; P<.0001). OS benefit was also observed in the PD-L1 high analysis set (19.1 vs 11.9 mo; HR=0.52 [95% CI: 0.38, 0.71])...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...

BeiGene, Ltd....today announced that the RATIONALE 303 trial of its anti-PD-1 antibody tislelizumab versus docetaxel in the second- or third-line setting in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)...The primary endpoint of the trial is OS in all patients (the ITT population) and in patients with high PD-L1 expression...met its primary endpoint of overall survival (OS) in the intention-to-treat (ITT) patient population at the planned interim analysis, as recommended by the independent Data Monitoring Committee (DMC).

...anti-PD-1 antibody tislelizumab has received approval from the China National Medical Products Administration (NMPA) as a treatment for patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy...

With severe underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse that may affect the explanation of drug toxicity or AEs or result in impaired compliance with study conduct.

A total of 49 patients with NSCLC...received tislelizumab....Median OS was 15.1 months (95% CI: 4.2, NR) for patients with PD-L1+ NSCLC and 11.2 months (95% CI: 6.1, NR) for patients with PD-L1–NSCLC....Tislelizumab was generally well tolerated and demonstrated antitumor activity in NSCLC patients.

...IHC showed that PD-L1 was strongly expressed (tumor proportion score [TPS]: 60%, combined positive score [CPS]:90) (Figure 2). The PD-1 antibody tislelizumab 200 mg q. 21 days was implemented on December 29, 2020. One cycle later, the patient's cough and breathlessness had reduced, and chest CT scan showed that the mass (4.1 x 3.9 cm) in the hilus of the right upper lobe of the lung and nodules in the subpleural region of the right lung had shrunk significantly, and the pleural effusion had disappeared. Tislelizumab monotherapy was maintained with a partial response (PR) achieved and no notable side effects occurred. Seven cycles later, the lesions had gradually shrunk to 1.6 x 1.3 cm and remained stable until now.