Ganymed’s IMAB362 almost doubles survival in gastric cancer, according to a new study. Ganymed Pharmaceuticals AG has announced its outstanding data from the Phase II clinical study of the monoclonal antibody at the ASCO 2016 Annual Meeting.
IMAB362 is a monoclonal antibody that targets the cell surface molecule Claudin18.2. The clinical study was carried out on people suffering from gastric cancer. The aim was to observe if IMAB362 increases immunity against stomach cancer when added as an adjunct to standard chemotherapy.
The antibody has obtained orphan drug designation in the United States and in Europe for gastric and pancreatic cancer. It’s a first-class immunotherapeutic investigational drug specific for the protein Claudin18.2. It works by activating the antibody-dependent cell mediated cytotoxicity and complement-dependent cytotoxicity. In combination with standard chemotherapy, it also activates T-cell infiltration and modulation of the microenvironment.
Stomach cancer patients have a short lifespan after their diagnosis. The disease is cruel and takes its course quickly. Unfortunately, treatment options are just as limited. However, trials held with Ganymed’s IMAB362 provide hope for the future.
This new therapy was tested on 161 patients suffering from advanced or recurrent gastric cancer. The individuals were then randomly assigned to receive either standard chemotherapy together with IMAB362 antibody, or chemotherapy alone. An additional 85 cancer patients were treated with a higher dose of IMAB362.
According to the researchers conducting the study, Ganymed’s IMAB362 almost doubles survival in gastric cancer. IMAB362 has greatly extended median overall survival after being added to chemotherapy. The numbers speak for themselves: 13.2 months versus 8.4 months.
Furthermore, patients with the highest Claudin18.2 levels had an even longer median overall survival. The time has increased from 9 months to 16.7 months.
The monoclonal antibody was generally well tolerated by the patients. Side effects included vomiting, nausea, and neutropenia. The rates of adverse effects had not increased with IMAB362 compared to those of chemotherapy alone.
According to the researchers, a Phase III study in gastric cancer patients is on the way, scheduled to begin in the first months of 2017. A larger additional research was needed to confirm the findings of this Phase II study. However, experts are already convinced and excited by the results showed by Ganymed’s IMAB362 this year.
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