A randomized, controlled trial evaluating the efficacy and safety of BTH1677 in combination with bevacizumab, carboplatin, and paclitaxel in first-line treatment of advanced non-small cell lung cancer

Journal for Immunotherapy of Cancer
Walburga Engel-RiedelFolker Schneller

Abstract

BTH1677, a beta-glucan pathogen-associated molecular pattern molecule, drives an anti-cancer immune response in combination with oncology antibody therapies. This phase II study explored the efficacy, pharmacokinetics (PK), and safety of BTH1677 combined with bevacizumab/carboplatin/paclitaxel in patients with untreated advanced non-small cell lung cancer (NSCLC). Patients were randomized to the BTH1677 arm (N = 61; intravenous [IV] BTH1677, 4 mg/kg, weekly; IV bevacizumab, 15 mg/kg, once each 3-week cycle [Q3W]; IV carboplatin, 6 mg/mL/min Calvert formula area-under-the-curve, Q3W; and IV paclitaxel, 200 mg/m2, Q3W) or Control arm (N = 31; bevacizumab/carboplatin/paclitaxel as above). Carboplatin/paclitaxel was discontinued after 4-6 cycles and patients who responded or remained stable received maintenance therapy with BTH1677/bevacizumab (BTH1677 arm) or bevacizumab (Control arm). Efficacy assessments, based on blinded central radiology review, included objective response rate (ORR; primary endpoint), disease control rate, duration of objective response, and progression-free survival. Overall survival and adverse events (AEs) were also assessed. ORR was higher in the BTH1677 vs Control arm but the difference between groups wa...Continue Reading

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Citations

Apr 17, 2019·The Journal of Immunology : Official Journal of the American Association of Immunologists·Nandita BoseRichard D Huhn
Mar 6, 2021·International Journal of Biological Macromolecules·Lijuan WuChenyang Zhao
Jul 3, 2021·Nutrients·Chiara CerlettiLicia Iacoviello
Oct 3, 2021·Journal of Experimental & Clinical Cancer Research : CR·Vincent LemaireAnand Rotte
Oct 26, 2021·Acta Biochimica Et Biophysica Sinica·Yanli LiZhongliang Ma

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Methods Mentioned

BETA
enzyme-linked immunosorbent assay

Clinical Trials Mentioned

NCT03003468
NCT02086175
NCT02981303

Software Mentioned

WinNonlin®

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