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Tislelizumab plus chemotherapy vs chemotherapy alone as treatment for advanced squamous non–small-cell lung cancer

JAMA Apr 07, 2021

Wang J, Lu S, Yu X, et al. - This open-label, randomized phase 3 clinical trial was undertaken to compare tislelizumab plus chemotherapy vs chemotherapy alone in terms of effectiveness and safety/tolerability for the first-line treatment of patients suffering from advanced squamous non–small-cell lung cancer (sq-NSCLC). Treatment-naïve, histologically proven stage IIIB/IV sq-NSCLC patients were randomly assigned 1:1:1 to one of the following treatment regimens intravenously on a 21-day cycle: tislelizumab (200 mg, day 1) plus paclitaxel (175 mg/m 2 , day 1) and carboplatin (area under the concentration of 5, day 1) (arm A); tislelizumab plus nab-paclitaxel (100 mg/m 2 , days 1, 8, and 15) and carboplatin (arm B); and paclitaxel and carboplatin (arm C). Treatment was received by a total of 355 patients with sq-NSCLC. Findings revealed that significantly prolonged independent review committee (IRC)-assessed progression-free survival, higher IRC-assessed objective response rates, as well as a manageable safety/tolerability profile, all were conferred by treatment with tislelizumab plus chemotherapy in advanced sq-NSCLC patients, irrespective of programmed cell death 1 ligand 1 expression. IRC-assessed PFS was significantly improved with tislelizumab plus chemotherapy (arm A, 7.6 months; arm B, 7.6 months) vs chemotherapy alone (arm C, 5.5 months) after a median study follow-up of 8.6 months. Higher IRC-assessed ORR and longer IRC-assessed duration of response were observed in arms A (8.2 months) and B (8.6 months) vs C (4.2 months). Discontinuation of any treatment because of AEs was reported in 12.5% of arm A, 29.7% of arm B, and 15.4% of arm C patients.

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