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Phase 2 Results of Gemcitabine and Monoclonal Antibody for Advanced Pancreatic Cancer

It’s hard to keep up with company changes in the biotech world, but a recent published study in the Annals of Oncology, the official journal of the European Society for Medical Oncology (ESMO) includes highly intriguing results of an unusual combination for advanced pancreatic cancer (ductal adenocarcinoma of the pancreas) of gemcitabine and the fully human monoclonal antibody (Mab) AGS-1C4D4.

This particular Mab has been developed by Agensys, Inc., which is an affiliate of Astellas Pharma Inc. (of Japan) and which also now includes the company OSI Pharmaceutical in their fold – that has given us Tarceva, one of the few drugs to be approved by the U.S. FDA (in combination with gemcitabine) for the treatment of pancreatic cancer.

In any case, the researchers of the study in question were from worldwide institutions, as anchored by M Hildago, published under the Dana-Farber (Harvard) Cancer Institute, involved ECOG institutions in the United States, and also included Pancreatica Science Board member, Eileen O’Reilly, MD of Memorial Sloan-Kettering Cancer Center.

They looked at 196 chemo naïve patients with advanced pancreatic cancer who were randomly assigned to receive either gemcitabine alone (63 patients) or the combination of gemcitabine and AGS-1C4D4 (133 patients).   At six months the median survival rate was 57.1% in the gemcitabine arm of the trial, and was 79.5% in the combination arm.

As the results of this clinical trial for metastatic pancreatic cancer are encouraging, we must assume that further studies with this gemcitabine plus monoclonal antibody treatment regimen will be forthcoming.

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Dale O’Brien, MD