Positive results of Phase II study of IMMU 132 in advanced Solid Tumours-Immunomedics

Immunomedics has announced that in a mid-stage Phase II clinical study a multitude of patients with late stage solid cancers showed significant and durable tumor shrinkage after receiving treatments with IMMU 132 (sacituzumab govitecan), including patients with metastatic triple-negative breast cancer whose cancers after treatment were no longer detected by computed tomography. At the time of analysis, a total of 184 patients with four major solid cancer types: breast, lung, oesophageal, and colorectal, are enrolled.

For patients with triple-negative breast cancer, 26% showed objective response to sacituzumab govitecan, with 2 having a complete disappearance of their tumors, or complete response, and 10 showing a 30% or better tumor reduction, which qualified them as partial responders. In lung cancer, the objective response rates were 32% and 30% for non-small-cell and small-cell lung cancers, respectively, and disease control rates were 74% and 55%, respectively. For the 18 patients with advanced cancer of the oesophagus enrolled into the study, 16 were assessable for response, having an objective response rate of 13% and a disease control rate of 44%. Finally, for 29 patients with colorectal cancer the median length of time living without the disease getting worse from the beginning of their sacituzumab govitecan treatments was 3.9 months. The median length of survival from the start of treatment was 18.0 months. Immunomedics is now in discussion with FDA to formulate a registration pathway for sacituzumab govitecan to advance the agent to Phase III.