Recently, eClinical Medicine, a sub-journal of The Lancet, published the results of a phase 1b/2 study of recombinant humanized monoclonal antibody MIL62 injection in combination with lenalidomide for the treatment of relapsed/refractory follicular lymphoma and marginal zone lymphoma, led by Prof. Yuankai Shi of Cancer Hospital, Chinese Academy of Medical Sciences. The study was designed to evaluate the efficacy and safety of MIL62 in combination with lenalidomide in the treatment of relapsed/refractory follicular lymphoma and marginal zone lymphoma.

Follicular lymphoma (FL) and marginal zone lymphoma (MZL) are common pathological subtypes of non-Hodgkin's lymphoma (NHL) and are inert lymphomas. In China, FL accounts for about 8% of B-cell NHL, while MZL accounts for about 12%. Early progression in patients with inert lymphoma is directly related to poor prognosis, with approximately 20% of patients experiencing disease recurrence or progression within 24 months of diagnosis (POD24). These patients typically have a poor prognosis, and new treatment options are urgently needed to address unmet clinical needs.

As a multicenter, open phase 1b/2 clinical study, 54 patients with relapsed/refractory FL and MZL were enrolled in this study. The study results showed that the overall objective remission rate (ORR) of MIL62 in combination with lenalidomide was 86.0%, which exceeded the protocol pre-determined rate of ≥65%; cumulatively, more than 31 subjects achieved complete remission (CR) or partial remission (PR), which met the study's pre-determined primary endpoint.

In the overall population, the CR rate was 26%, the disease control rate (DCR) was 96%, the 12-month progression-free survival (PFS) rate was 72%, and the 12-month overall survival (OS) rate was 98%. Among the results analyzed for different subgroups, among 20 patients with first-generation CD20 antibody (rituximab) refractory FL, the ORR was 80%, the DCR was 100%, the 12-month PFS rate was 72%, and the 12-month OS rate was 100%. In 31 patients with POD24, the ORR was 84%, the DCR was 97%, the 12-month PFS rate was 68%, and the 12-month OS rate was 100%.

This study further demonstrates that MIL62 can overcome the resistance of first-generation CD20 antibodies and is expected to provide a new treatment option for patients with CD20 monotherapy-refractory FL.

MIL62 in combination with lenalidomide for the treatment of relapsed/refractory follicular lymphoma and marginal zone lymphoma showed profound and durable efficacy with a manageable safety profile, thanks to MIL62's stronger antibody-dependent cell-mediated cytotoxic effect (ADCC) and the ability to remove abnormally activated B cells in vivo," said Prof. Yuankai Shi. These findings suggest that MIL62 is expected to be an ideal treatment option for patients with relapsed/refractory FL or MZL. Based on the data from the Phase 1b/2 clinical study, MIL62 in combination with lenalidomide versus lenalidomide is undergoing a Phase 3 randomized controlled clinical trial in CD20 monoclonal antibody-refractory FL, and we look forward to more breakthroughs of MIL62, a national innovative drug, in future studies to benefit patients in China and around the world."

Mabworks' core product, MIL62, is an innovative third-generation CD20 recombinant humanized monoclonal antibody developed independently. The product is based on an independently innovative ADCC-enhanced antibody platform, and has been supported by the National Special Project for the Creation of Major New Drugs. The Drug Evaluation Center of the State Drug Administration has officially included MIL62 in the "breakthrough therapy" list for the treatment of primary membranous nephropathy (PMN). In addition, MIL62 is undergoing clinical trials for refractory FL, systemic lupus erythematosus (SLE) and neuromyelitis optica spectrum disease (NMOSD). In the future, as MIL62's clinical studies continue to advance, it is expected to bring more effective and safer medication options to Chinese patients to meet their unmet clinical needs.

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