China-based Wuhan YZY Biopharma Co., Ltd (HKG: 2496) has announced the presentation of results from a Phase II clinical study for its M701, a recombinant anti-EpCAM and CD3 human murine chimeric bispecific antibody (BsAb) injection, at the ESMO ASIA Congress 2024. The study focused on patients with malignant pleural effusion caused by advanced epithelial solid tumors.
M701’s Mechanism of Action and Study Design
M701 is engineered to activate immune cells while inhibiting tumor cell growth in the chest cavity, thereby achieving the effect of inhibiting pleural effusion. The study enrolled subjects in a 1:1 ratio for the experimental and control groups. After abdominal puncture and drainage, the experimental group received intraperitoneal infusion of M701 at specific dosages and frequencies, followed by regular administrations without further drainage of ascites. The control group underwent abdominal puncture and drainage as needed before day 18, with no ascites drainage thereafter.
Significant Improvements in Non Puncture Survival Time
The non puncture survival time of the experimental group was significantly longer than that of the control group, with a median of 75 days versus 23 days (HR=0.40, p=0.0085). This benefit was more pronounced for patients with a lymphocyte percentage of 13% or higher, with a median of 125 days versus 22 days (HR=0.22, p=0.0001). The analysis of overall survival (OS) showed a trend of prolonged survival in subjects treated with M701, with a median of 111 days versus 86 days (HR=0.65, p=0.102). The 6-month survival rates were 32.3% for the experimental group and 12.6% for the control group. Among patients with a lymphocyte percentage of 13% or higher, there was a significant benefit in OS, with a median of 139 days versus 82 days (HR=0.51, p=0.026).-Fineline Info & Tech
