Prolgolimab with chemotherapy as first-line treatment for advanced non-squamous non-small-cell lung cancer.
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Laktionov K, Smolin A, Stroyakovskiy D, Moiseenko V, Dvorkin M, Andabekov T, Cheng Y, Liu B, Kozlov V, Odintsova S, Dvoretsky S, Mochalova A, Urda M, Yi T, Li X, László U, Müller V, Bogos K, Fadeeva N, Musaev G, Liu Q, Kirtbaya D, Shi J, Gladkov O, Narimanov M, Semiglazova T, Khasanova A, Chovanec J, Andrašina I, Szabová A, Rosinská O, Sudekova D, Zsolt P-S, Ran F, Sun M, Jiang O, Chen R, Zhao E, Liu C, Tan W, Pirmagomedov A, Poddubskaya E, Kislov N, Shumskaya I, Sorokina I, Zinkina-Orikhan A, Linkova Yu, Fogt S, Liaptseva D, Siliutina A, Basova O, Kryukov F
Аннотация
METHODS: 292 patients with advanced non-squamous NSCLC were randomized 1:1 to receive 4 cycles of pemetrexed, platinum-based drug and either prolgolimab (3 mg/kg Q3W) or placebo followed by prolgolimab/placebo with pemetrexed until disease progression or toxicity (≤36 months). The primary endpoint was overall survival (OS).
RESULTS: After a median follow-up of 18 months, the median OS was not reached (95 % CI, 22.28 - NA) in the prolgolimab-combination group vs 14.6 months (95 % CI, 11.73 - 19.15) in the placebo-combination group (HR, 0.51; 95 % CI, 0.35 - 0.73, p = 0.0001). The OS improvement was independent of PD-L1 status. Median progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was 7.7 months in the prolgolimab-combination group and 5.5 months in the placebo-combination group (HR, 0.65; 95 % CI, 0.49 - 0.85, p = 0.0004). The only adverse events that were reported in at least 10 % of the patients that were significantly more frequent in the prolgolimab-combination group were blood creatinine increased and dyspnoea.
CONCLUSION: Among patients with advanced NSCLC the addition of prolgolimab to pemetrexed and a platinum-based drug increased OS and PFS, with no new safety concerns. This benefit was retained in patients with PD-L1 negative tumors. (ClinicalTrials.gov, NCT03912389).