Open AccessPhase I/Ib dose-escalation study of avelumab in Chinese patients with advanced solid tumors
Author(s) -
YiLong Wu,
Ying Cheng,
Huajun Chen,
HaiYan Tu,
ChongRui Xu,
Zhen Wang,
Ying Li,
Ying Xin,
Hongbo Lou,
Wei Wang,
Kevin M. Chin,
Dandan Li,
Dongyuan Zhao,
Youhe Gao,
Wenrong Xu,
Hongming Pan
Publication year - 2022
Publication title -
future oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.857
H-Index - 72
eISSN - 1744-8301
pISSN - 1479-6694
DOI - 10.2217/fon-2021-1342
Subject(s) - avelumab , medicine , oncology , antibody , immunotherapy , cancer , immunology , pembrolizumab
Aim: Data for avelumab (anti-PD-L1 antibody) in Chinese patients are limited. Patients & methods: Phase I/Ib, open-label, dose-escalation study of Chinese patients with advanced solid tumors. Primary study objectives were to evaluate the maximum tolerated dose (MTD) and pharmacokinetics (PK) of avelumab. Results: 24 patients received avelumab 3 mg/kg every 2 weeks (Q2W; n = 3), 10 mg/kg Q2W (n = 7), 20 mg/kg Q2W (n = 6) or 10 mg/kg weekly for 12 weeks and then Q2W thereafter (n = 8). MTD was not reached. Avelumab exposure was increased in higher dose groups. Partial responses occurred in two patients (confirmed in one patient); best overall response was stable disease in nine patients. Conclusion: Data for avelumab in Chinese patients with advanced solid tumors were consistent with previous global studies.