دورية أكاديمية
SAPPHIRE:phase III study of sitravatinib plus nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer
| العنوان: | SAPPHIRE:phase III study of sitravatinib plus nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer |
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| المؤلفون: | Borghaei, H., de Marinis, F., Dumoulin, D., Reynolds, C., Theelen, W. S.M.E., Percent, I., Gutierrez Calderon, V., Johnson, M. L., Madroszyk-Flandin, A., Garon, E. B., He, K., Planchard, D., Reck, M., Popat, S., Herbst, R. S., Leal, T. A., Shazer, R. L., Yan, X., Harrigan, R., Peters, S., Chella, Antonio |
| المصدر: | Borghaei , H , de Marinis , F , Dumoulin , D , SAPPHIRE Investigators , Reynolds , C , Theelen , W S M E , Percent , I , Gutierrez Calderon , V , Johnson , M L , Madroszyk-Flandin , A , Garon , E B , He , K , Planchard , D , Reck , M , Popat , S , Herbst , R S , Leal , T A , Shazer , R L , Yan , X , Harrigan , R , Peters , S & Chella , A 2024 , ' .... |
| سنة النشر: | 2024 |
| مصطلحات موضوعية: | /dk/atira/pure/sustainabledevelopmentgoals/good_health_and_well_being, name=SDG 3 - Good Health and Well-being |
| الوصف: | Background: Checkpoint inhibitor (CPI) therapy revolutionized treatment for advanced non-small-cell lung cancer (NSCLC); however, most patients progress due to primary or acquired resistance. Sitravatinib is a receptor tyrosine kinase inhibitor that can shift the immunosuppressive tumor microenvironment toward an immunostimulatory state. Combining sitravatinib with nivolumab (sitra + nivo) may potentially overcome initial CPI resistance. Patients and methods: In the phase III SAPPHIRE study, patients with advanced non-oncogenic driven, nonsquamous NSCLC who initially benefited from (≥4 months on CPI without progression) and subsequently experienced disease progression on or after CPI combined with or following platinum-based chemotherapy were randomized 1: 1 to sitra (100 mg once daily administered orally) + nivo (240 mg every 2 weeks or 480 mg every 4 weeks administered intravenously) or docetaxel (75 mg/m 2 every 3 weeks administered intravenously). The primary endpoint was overall survival (OS). The secondary endpoints included progression-free survival (PFS), objective response rate (ORR), clinical benefit rate (CBR), duration of response (DOR; all assessed by blinded independent central review), and safety. Results: A total of 577 patients included randomized: sitra + nivo, n = 284; docetaxel, n = 293 (median follow-up, 17.1 months). Sitra + nivo did not significantly improve OS versus docetaxel [median, 12.2 versus 10.6 months; hazard ratio (HR) 0.86, 95% confidence interval (CI) 0.70-1.05; P = 0.144]. The median PFS was 4.4 versus 5.4 months, respectively (HR 1.08, 95% CI 0.89-1.32; P = 0.452). The ORR was 15.6% for sitra + nivo and 17.2% for docetaxel (P = 0.597); CBR was 75.5% and 64.5%, respectively (P = 0.004); median DOR was 7.4 versus 7.1 months, respectively (P = 0.924). Grade ≥3 treatment-related adverse events were observed in 53.0% versus 66.7% of patients receiving sitra + nivo versus docetaxel, respectively. Conclusions: Although median OS was numerically longer with sitra + nivo, the primary ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | https://pure.eur.nl/en/publications/0b1e2f00-23dd-4b41-ab78-5c0bd556fcecTest |
| DOI: | 10.1016/j.annonc.2023.10.004 |
| الإتاحة: | https://doi.org/10.1016/j.annonc.2023.10.004Test https://pure.eur.nl/en/publications/0b1e2f00-23dd-4b41-ab78-5c0bd556fcecTest http://www.scopus.com/inward/record.url?scp=85178324517&partnerID=8YFLogxKTest |
| حقوق: | info:eu-repo/semantics/closedAccess |
| رقم الانضمام: | edsbas.1ED72DB |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/j.annonc.2023.10.004 |
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