Non-Small Cell Lung Cancer Coverage from Every Angle

RATIONALE 303 Update on Tislelizumab Versus Docetaxel in Advanced NSCLC

By: Vanessa A. Carter, BS
Posted: Tuesday, May 11, 2021

Caicun Zhou, PhD, MD, of Shanghai Pulmonary Hospital, China, and colleagues presented their study results on the use of the anti–PD-1 inhibitor tislelizumab versus docetaxel as second- or third-line treatment of non–small cell lung cancer (NSCLC) during the virtual edition of the American Association for Cancer Research (AACR) Annual Meeting 2021 (Abstract CT039). These researchers reported that tislelizumab was tolerable and prolonged progression-free and overall survival by 5 to 7 months, regardless of PD-L1 expression or histology.

The phase III RATIONALE 303 trial focused on 805 patients with locally advanced or metastatic NSCLC without an oncogenic driver mutation whose disease progressed or recurred after one prior line of platinum-based chemotherapy. Participants were randomly assigned 2:1 to receive either 200 mg of tislelizumab (arm A, n = 535) or 75 mg of docetaxel (arm B, n = 270), and treatment was continued until unacceptable toxicity or disease progression.

The median overall survival was 17.2 months in arm A and 11.9 months in arm B (hazard ratio [HR] = 0.64, P = < .0001). For patients on tislelizumab, the 12-month and 24-month overall survival rates were 61.9% and 39.4%, respectively; those on docetaxel had corresponding rates of 49.8% and 25.0%.

In participants with high PD-L1 expression, an overall survival benefit was observed for patients on tislelizumab (HR = 0.52). Individuals treated with tislelizumab had 12- and 24-month overall survival rates of 67.5% and 44.7%, whereas patients given docetaxel had rates of 49.1% and 24.5%, respectively. Those on tislelizumab had a median progression-free survival of 4.1 months, an objective response rate of 21.9%, and a disease control rate of 55.7%; the progression-free survival for docetaxel was 2.6 months, an objective response rate was 7.1%, and a disease control rate was 47.2%. Treatment-related adverse events occurred less often with tislelizumab than with docetaxel (73% vs. 93.8%), including events of grade 3 or greater (14.4% vs. 66.3%).

Disclosure: For full disclosures of the study authors, visit

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