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Barlesi, Fabrice; Tomasini, Pascale; Karimi, Maryam; Michiels, Stefan; Raimbourg, Judith; Daniel, Catherine; Janicot, Henri; Madroszyk, Anne; Audigier-Valette, Clarisse; Quoix, Elisabeth; Mazieres, Julien; Moro-Sibilot, Denis; Dansin, Eric; Molinier, Olivier; Morel, Hugues; Pichon, Eric; Cortot, Alexis; Otto, Josiane; Chomy, François; Souquet, Pierre-Jean; Cloarec, Nicolas; Giroux-Leprieur, Etienne; Bieche, Ivan; Lacroix, Ludovic; Boyault, Sandrine; Attignon, Valery; Soubeyran, Isabelle; Morel, Alain; Tran-Dien, Alicia; Jacquet, Alexandra; Dall'Olio, Filippo Gustavo; Jimenez, Marta; Soria, Jean-Charles; Besse, Benjamin
Clinical cancer research, 09/2022, Volume: 28, Issue: 18Journal Article
Targeted therapies (TT) and immune checkpoint blockers (ICB) have revolutionized the approach to non-small cell lung cancer (NSCLC) treatment in the era of precision medicine. Their impact as switch maintenance therapy based on molecular characterization is unknown. SAFIR02-Lung/IFCT 1301 was an open-label, randomized, phase II trial, involving 33 centers in France. We investigated eight TT (substudy-1) and one ICB (substudy-2), compared with standard-of-care as a maintenance strategy in patients with advanced EGFR, ALK wild-type (wt) NSCLC without progression after first-line chemotherapy, based on high-throughput genome analysis. The primary outcome was progression-free survival (PFS). Among the 175 patients randomized in substudy-1, 116 received TT (selumetinib, vistusertib, capivasertib, AZD4547, AZD8931, vandetanib, olaparib, savolitinib) and 59 standard-of-care. Median PFS was 2.7 months 95% confidence interval (CI), 1.6-2.9 with TT versus 2.7 months (1.6-4.1) with standard-of-care (HR, 0.97; 95% CI, 0.7-1.36; P = 0.87). There were no significant differences in PFS within any molecular subgroup. In substudy-2, 183 patients were randomized, 121 received durvalumab and 62 standard-of-care. Median PFS was 3.0 months (2.3-4.4) with durvalumab versus 3.0 months (2.0-5.1) with standard-of-care (HR, 0.86; 95% CI, 0.62-1.20; P = 0.38). Preplanned subgroup analysis showed an enhanced benefit with durvalumab in patients with PD-L1 tumor proportion score (TPS) ≥1%, (n = 29; HR, 0.29; 95% CI, 0.11-0.75) as compared with PD-L1 <1% (n = 31; HR, 0.71; 95% CI, 0.31-1.60; Pinteraction = 0.036). Molecular profiling can feasibly be implemented to guide treatment choice for the maintenance strategy in EGFR/ALK wt NSCLC; in this study it did not lead to substantial treatment benefits beyond durvalumab for PD-L1 ≥ 1 patients.
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