RATIONALE 303 trial, presented at AACR 2021, compared the efficacy and safety of monoclonal antibody versus docetaxel
The RATIONALE 303 trial (NCT03358875), which compared the efficacy and safety of tislelizumab versus docetaxel as second- or third-line therapy for patients with advanced non-small cell lung cancer (NSCLC), was presented during the American Association for Cancer Research (AACR) Annual Meeting 2021.
Patients without driver mutation who failed at least one prior systemic therapy, including platinum, were randomized 2:1 to receive tislelizumab 200mg IV every three weeks (Group A) or docetaxel 75 mg/m2 IV every three weeks (Group B).
The primary outcomes were overall survival (OS) in the intention-to-treat (ITT) analysis set and OS in the high PD-L1 (≥ 25% expression in tumor cells). A previously specified interim analysis was conducted after approximately 426 deaths (76% of planned events), in which the formal superiority test for overall survival was conducted only in the ITT population.
In total, 805 participants were randomized (n = 535 for tislelizumab; n = 270 for docetaxel). Demographic characteristics were balanced between arms. At a median follow-up of 19 months (441 SG events), the median OS in the ITT population was significantly higher in Arm A versus B (17.2 vs 11.9 months; HR 0.64; CI 95% 0.53 – 0.78; P< 0.0001). The OS benefit was also observed in the high PD-L1 analysis set (19.1 vs 11.9 months; HR 0.52; CI 95% 0.38 – 0.71) and in most subgroups, including histology.
In the ITT analysis set, progression-free survival (PFS), objective response rate (ORR) and duration of response (DoR) were also higher in Arm A vs B:
In patients receiving tislelizumab, anemia was the most common adverse event and pneumonia was the most frequent AE grade ≥ 3. AEs leading to death were 6.0% for those treated with immunotherapy and treatment-related AEs that led to death were 1.5% in arm A. As for patients receiving docetaxel, alopecia was the most common AE and neutropenia the most frequent AE grade ≥ 3. AEs leading to death were 4.3% for patients who received chemotherapy and treatment-related AEs that lead to death were 1.6% for group B.
The researchers concluded that tislelizumab has a favorable tolerability profile and OS was prolonged for 5-7 months, including improvements in terms of PFS, ORR, and DoR compared to docetaxel as a second– or third line therapy in patients with advanced NSCLC, regardless of histology or PD-L1 expression.
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