Abstract 895P
Background
A novel glycoengineered, humanized type Ⅱ anti-CD20 monoclonal antibody, MIL62 is glycoengineered with a nearly completed nonfucosylated Fc region. MIL62 has demonstrated superior activity compared with rituximab and obinutuzumab in vitro and in vivo, respectively.
Methods
This was an open-label, multicenter, dose-escalating and followed by dose-expansion study (NCT04103905) enrolling patients from November 2017 to November 2018. Adult patients in China with relapsed/refractory CD20-positive B-cell non-Hodgkin’s lymphoma (NHL) were enrolled into 5 sequential dose cohorts (200 mg, 400 mg, 800 mg, 1000 mg and 1500 mg). The study was expanded in 800mg and 1000mg.
Results
Among the total of 27 patients, they received a median of two lines of anticancer treatment prior to the enrollment. No dose-limiting toxicity (DLT) or unexpected adverse events (AEs) were observed. The most common treatment related AEs were thrombocytopenia (n=15), neutropenia (n=14), and leukopenia (n=14). Among these, a total of 30 grade 3 or 4 AEs occurred in 9 patients. Hematologic AEs were resolved with appropriate management. Only grade 1 infusion-related reaction was observed and experienced with 4 patients. Objective response rate (ORR) was 44.4%. Twelve patients achieved partial response (PR), 5 with follicular lymphoma, 2 with marginal zone lymphoma, 2 with chronic lymphocytic leukemia, 2 with diffuse large B-cell lymphoma and 1 with Hodgkin's lymphoma.
Conclusions
MIL62 was well tolerated and had encouraging activities in Chinese patients with relapsed/refractory CD20-positive B-cell NHL.
Clinical trial identification
NCT04103905; September 26, 2019.
Editorial acknowledgement
Legal entity responsible for the study
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.
Funding
Beijing Mab-works Biotech Co. Ltd.
Disclosure
F. Li: Full/Part-time employment, Mr. Feng Li has an employment relationship with Beijing Mabworks Biotech Co. Ltd. All other authors have declared no conflicts of interest.