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• W3139237541 abstract "Trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate composed of an anti-HER2 antibody, cleavable tetrapeptide-based linker, and potent topoisomerase I inhibitor. In a phase 2 trial in patients with heavily pretreated, metastatic HER2+ breast cancer, T-DXd had a confirmed objective response rate (cORR) of 60.9% (112/184) and median progression-free survival (PFS) of 16.4 mo (Modi N Engl J Med 2019); these results led to the recent FDA approval for HER2+ unresectable or metastatic breast cancer after ≥ 2 prior anti-HER2 based regimens. For HER2-low breast cancer and HER2-expressing/mutated NSCLC, no HER2-directed therapies have been approved. In a phase 1 trial of T-DXd in patients with HER2-low breast cancer or HER2-expressing/mutated NSCLC, cORR was 44.2% (19/43) (Modi SABCS 2018), and 55.6% (10/18) (Tsurutani Thorac Oncol 2018), respectively. In preclinical models, T-DXd combined with an anti–PD-1 antibody was more effective than monotherapy with either agent (Iwata Mol Cancer Ther 2018). Here we describe a phase 1b study of T-DXd in combination with pembrolizumab in patients with locally advanced/metastatic HER2-expressing breast cancer or HER2-expressing/mutated NSCLC (DS8201-A-U106; NCT04042701). This abstract was previously submitted to ASCO 2020. This is an open-label, multicenter, nonrandomized, multidose, 2-part study in adult (aged ≥18 y) patients in the United States and Europe. In part 1 (dose escalation), patients received T-DXd 3.2 or 5.4 mg/kg IV q3w and pembrolizumab 200 mg IV q3w to determine the recommended dose for expansion (RDE). The RDE will be given to 4 cohorts (part 2): 2 cohorts with breast cancer (HER2+ [IHC 3+ or IHC 2+/ISH+] with progression on prior T-DM1; and HER2-low [IHC 1+ or IHC2+/ISH-] with progression on prior standard treatments) and 2 cohorts with NSCLC (anti–PD-1, –PD-L1, and -HER2 treatment naive either HER2-expressing [IHC ≥ 1+] or HER2-mutated). Enrollment began in February 2020 with approximately 115 to 133 patients planned to be enrolled at 5 sites for part 1 and expanding to 25 sites for part 2. The primary endpoint in part 1 is dose-limiting toxicities. The part 2 primary efficacy endpoint is cORR by independent central review (ICR) per RECIST 1.1. Additional endpoints include duration of response, disease control rate, and progression-free survival by ICR, overall survival, safety, and pharmacokinetics. Conclusion Trastuzumab deruxtecan, Pembrolizumab, HER2-expressing/mutated NSCLC" @default.
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• W3139237541 date "2021-03-01" @default.
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• W3139237541 title "P01.02 Trastuzumab Deruxtecan Plus Pembrolizumab in Advanced/Metastatic Breast or Non-Small Cell Lung Cancer: A Phase 1b Study" @default.
• W3139237541 doi "https://doi.org/10.1016/j.jtho.2021.01.326" @default.
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