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ABRAXANE® Plus Gemcitabine Demonstrates Significant Survival Advantage In Phase III Study Of Patients With Advanced Pancreatic Cancer

Stocks in this article: CELG

“We are excited by the results of the Abraxane MPACT study and the potential this treatment combination may bring to patients with advanced pancreatic cancer,” said Jean-Pierre Bizzari, M.D., Executive Vice President, Global Head Hematology & Oncology Clinical Research, Celgene Corporation. “As the largest phase III real-world clinical trial in advanced pancreatic cancer, the clinically meaningful findings seen across key study endpoints and patient subgroups are a reflection of our ongoing commitment to develop innovative new therapies in critical areas of need.”

Further details of the study will be highlighted in a late-breaking oral presentation by Dr. Daniel D. Von Hoff:

  • Abstract: LBA #148: Final results of a randomized phase III study of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic adenocarcinoma of the pancreas. Friday, January 25 th between 2:00 to 3:30 pm PST at the American Society of Clinical Oncology’s (ASCO) 2013 Gastrointestinal Cancers Symposium in San Francisco, CA.

Based on the results of the MPACT study, Celgene plans to submit dossiers for registration in the US and Europe during the first half of 2013 followed by submissions in other countries/regions during the second half of 2013.

These results are from an investigational phase III study. ABRAXANE is not currently approved for the treatment of advanced pancreatic cancer.

About the MPACT Study

In the MPACT ( Metastatic Pancreatic Adenocarcinoma Clinical Trial) study, a Celgene-sponsored, open-label, randomized, international study of 861 metastatic pancreatic cancer patients were randomized to receive either ABRAXANE plus gemcitabine (125 mg/m 2 followed by 1000 mg/m 2 gemcitabine for 3 weeks followed by a week of rest) or gemcitabine alone (1000 mg/m 2 administered weekly for 7 weeks followed by a week of rest followed by cycles of weekly administration for 3 weeks followed by one week of rest). The primary endpoint for the study is improvement in overall survival. Secondary endpoints were progression-free survival, and overall response rate determined by independent radiological review. Other endpoints included progression-free survival, overall response rate determined by investigator and the safety and tolerability of this combination in this patient population.

About Advanced Pancreatic Cancer

Advanced pancreatic cancer is a difficult-to-treat cancer with the lowest survival rates among all cancer types. Across all patients with pancreatic cancer, relative 5-year survival is 6% and is less than 2% for those with advanced disease. There are two main types of pancreatic cancer - adenocarcinomas, which accounts for approximately 90% of all pancreatic cancer, and neuroendocrine tumors. Pancreatic cancer is relatively uncommon with new cases accounting for only 2.1% of all newly diagnosed cancers. However, pancreatic cancer is the fourth most common cause of cancer death in the United States and eighth globally.

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