Safety and efficacy of trastuzumab biosimilar plus irinotecan or gemcitabine in patients with previously treated HER2 (ERBB2)-positive non-breast/non-gastric solid tumors: a phase II basket trial with circulating tumor DNA analysis

ESMO Open - Tập 8 - Trang 101583 - 2023
J. Hyung1, J.Y. Lee2,3, J.E. Kim1, S. Yoon1, C. Yoo1, Y.S. Hong1, J.H. Jeong1, T.W. Kim1, S. Jeon2,3, H.R. Jun2,3, C.K. Jung4, J.P. Jang4, J. Kim5, S.M. Chun3,5, J.H. Ahn1
1Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul
2Department of Medical Science, Asan Medical Institute of Convergence Science and Technology, Asan Medical Center, University of Ulsan College of Medicine, Seoul
3Asan Center for Cancer Genome Discovery, Asan Institute for Life Science, Asan Medical Center, Seoul
4Genopeaks Co., Ltd., Seoul
5Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea

Tài liệu tham khảo

Omar, 2015, HER2: an emerging biomarker in non-breast and non-gastric cancers, Pathogenesis, 2, 1, 10.1016/j.pathog.2015.05.002 Bang, 2010, Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial, Lancet, 376, 687, 10.1016/S0140-6736(10)61121-X Slamon, 2001, Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2, N Engl J Med, 344, 783, 10.1056/NEJM200103153441101 Verma, 2012, Trastuzumab emtansine for HER2-positive advanced breast cancer, N Engl J Med, 367, 1783, 10.1056/NEJMoa1209124 Swain, 2020, Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study, Lancet Oncol, 21, 519, 10.1016/S1470-2045(19)30863-0 Hainsworth, 2018, Targeted therapy for advanced solid tumors on the basis of molecular profiles: results from MyPathway, an open-label, phase IIa multiple basket study, J Clin Oncol, 36, 536, 10.1200/JCO.2017.75.3780 Wan, 2017, Liquid biopsies come of age: towards implementation of circulating tumour DNA, Nat Rev Cancer, 17, 223, 10.1038/nrc.2017.7 Ignatiadis, 2021, Liquid biopsy enters the clinic - implementation issues and future challenges, Nat Rev Clin Oncol, 18, 297, 10.1038/s41571-020-00457-x Diehl, 2008, Circulating mutant DNA to assess tumor dynamics, Nat Med, 14, 985, 10.1038/nm.1789 Woodhouse, 2020, Clinical and analytical validation of FoundationOne Liquid CDx, a novel 324-Gene cfDNA-based comprehensive genomic profiling assay for cancers of solid tumor origin, PLoS One, 15, 10.1371/journal.pone.0237802 Kim, 2017, Prospective feasibility study for using cell-free circulating tumor DNA–guided therapy in refractory metastatic solid cancers: an interim analysis, JCO Precis Oncol, 1, 1, 10.1200/PO.16.00059 Pivot, 2016, A randomized phase I pharmacokinetic study comparing biosimilar candidate SB3 and trastuzumab in healthy male subjects, Clin Ther, 38, 1665, 10.1016/j.clinthera.2016.06.002 Pivot, 2018, J Clin Oncol, 36, 968, 10.1200/JCO.2017.74.0126 Khiabanian, 2018, Inference of germline mutational status and evaluation of loss of heterozygosity in high-depth, tumor-only sequencing data, JCO Precis Oncol, 1, 10.1200/PO.17.00148 Meric-Bernstam, 2019, Pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer (MyPathway): an updated report from a multicentre, open-label, phase 2a, multiple basket study, Lancet Oncol, 20, 518, 10.1016/S1470-2045(18)30904-5 Sartore-Bianchi, 2016, Dual-targeted therapy with trastuzumab and lapatinib in treatment-refractory, KRAS codon 12/13 wild-type, HER2-positive metastatic colorectal cancer (HERACLES): a proof-of-concept, multicentre, open-label, phase 2 trial, Lancet Oncol, 17, 738, 10.1016/S1470-2045(16)00150-9 Javle, 2021, Pertuzumab and trastuzumab for HER2-positive, metastatic biliary tract cancer (MyPathway): a multicentre, open-label, phase 2a, multiple basket study, Lancet Oncol, 22, 1290, 10.1016/S1470-2045(21)00336-3 Oh, 2022, Gemcitabine and cisplatin plus durvalumab with or without tremelimumab in chemotherapy-naive patients with advanced biliary tract cancer: an open-label, single-centre, phase 2 study, Lancet Gastroenterol Hepatol, 7, 522, 10.1016/S2468-1253(22)00043-7 Lamarca, 2021, Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trial, Lancet Oncol, 22, 690, 10.1016/S1470-2045(21)00027-9 Yoo, 2021, Liposomal irinotecan plus fluorouracil and leucovorin versus fluorouracil and leucovorin for metastatic biliary tract cancer after progression on gemcitabine plus cisplatin (NIFTY): a multicentre, open-label, randomised, phase 2b study, Lancet Oncol, 22, 1560, 10.1016/S1470-2045(21)00486-1 Valle, 2021, Biliary tract cancer, Lancet, 397, 428, 10.1016/S0140-6736(21)00153-7 Gao, 2017, Circulating tumor DNA functions as an alternative for tissue to overcome tumor heterogeneity in advanced gastric cancer, Cancer Sci, 108, 1881, 10.1111/cas.13314 Siravegna, 2019, Plasma HER2 (ERBB2) copy number predicts response to HER2-targeted therapy in metastatic colorectal cancer, Clin Cancer Res, 25, 3046, 10.1158/1078-0432.CCR-18-3389 Nakamura, 2021, Circulating tumor DNA-guided treatment with pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer: a phase 2 trial, Nat Med, 27, 1899, 10.1038/s41591-021-01553-w Wang, 2019, Liquid biopsies to track trastuzumab resistance in metastatic HER2-positive gastric cancer, Gut, 68, 1152, 10.1136/gutjnl-2018-316522 Yarlagadda, 2019, Trastuzumab and pertuzumab in circulating tumor DNA ERBB2-amplified HER2-positive refractory cholangiocarcinoma, NPJ Precis Oncol, 3, 19, 10.1038/s41698-019-0091-4 Shitara, 2020, Trastuzumab deruxtecan in previously treated HER2-positive gastric cancer, N Engl J Med, 382, 2419, 10.1056/NEJMoa2004413 Yoshino, 2022, Trastuzumab deruxtecan (T-DXd; DS-8201) in patients (pts) with HER2-expressing metastatic colorectal cancer (mCRC): final results from a phase 2, multicenter, open-label study (DESTINY-CRC01), J Clin Oncol, 40, 119, 10.1200/JCO.2022.40.4_suppl.119 Cortés J, 2022, Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer, N Engl J Med, 386, 1143, 10.1056/NEJMoa2115022 Modi, 2022, Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer, N Engl J Med, 387, 9, 10.1056/NEJMoa2203690