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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 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.

More here

Dale O’Brien, MD

MicroRNA plus CA19-9 as a Diagnostic Marker for Pancreatic Cancer?

The search for a screening or diagnostic marker in pancreatic cancer is paramount. If the disease could be found earlier, it is likely that serious inroads could be made into improved survival advantage for patients.

Wang and associates at Fudan University in Shanghai, China published an intriguing article in April’s edition of the Journal of Cancer Prevention Research which investigated microRNA patterns in the peripheral mononuclear blood cells of healthy patients, those with benign pancreatic disease, and those with pancreatic cancer.  They found that miR-27a-3p levels in these cells could differentiate patients with benign pancreatic disease from those with pancreatic cancer.

When the researchers added CA19-9 levels to those of miR-27a-3p, they found that the accuracy of this putative diagnostic test increased to a very satisfactory sensitivity of 85.3% with a specificity of 81.6%.

A very interesting aspect of the study is that this was found in peripheral blood cells – thus giving easy access through a simple blood draw to diagnostic results.

These are early days for the role of MicroRNA in the diagnosis of pancreatic cancer, but the results of this intriguing study should serve to increase additional research and confirmatory study.

More here

Dale O’Brien, MD

More Abraxane in Combination with Gemcitabine for Pancreatic Cancer

Two studies have been published on April 1, 2013 about the efficacy of the combination drug regimen of nab-Paclitaxel (Abraxane) plus gemcitabine.  These follow closely the earlier results of the international study of 861 patients with advanced pancreatic cancer who appeared to have gained survival advantage as presented by Dr. Daniel Von Hoff and colleagues at the ASCO GI symposium in San Francisco on January 24-26, 2013 (reported here on the Pancreatica blog on November 30, 2012 – see archives).

The first of these new studies was a phase 2 clinical trial of 19 patients with metastatic pancreatic cancer published in the American Journal of Clinical Oncology by Lima and colleagues from the University of Miami and Johns Hopkins (Singapore International Medical Center) which showed that this combination was tolerated well, and that it appeared to have clinical activity.

The second study in Cancer Chemotherapy and Pharmacy by Xu and colleagues which looked at the effect of the Abraxane and gemcitabine combination in Chinese patients with metastatic pancreatic cancer. Again, these researchers found significant results as far as activity against pancreatic cancer tumors; and with a generally tolerable side-effect profile.

The results of these studies are beginning to offer encouragement.

More here

and here

Dale O’Brien, MD




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