?Celgene International S?rl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG), today announced the results of the MPACT (Metastatic?PancreaticAdenocarcinoma?Clinical?Trial) phase III clinical trial of ABRAXANE? (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine were published online in the October 16th edition of the?New England?Journal of Medicine.
The MPACT study, chaired by lead author and study principal investigator, Dr. Daniel D. Von Hoff, Chief Scientific Officer for Scottsdale Healthcare?s Virginia G. Piper Cancer Center Clinical Trials and Physician-In-Chief for the Translational Genomics Research Institute (TGen), is a Celgene-sponsored, open-label, randomized, study of 861 previously untreated patients with metastatic pancreatic cancer at 151 community and academic centers from 11 countries in North America, Eastern and Western Europe and Australia. The article, titled ?Increased Survival in Pancreatic Cancer with?nab-Paclitaxel plus Gemcitabine,? is available online at?http://www.nejm.org/doi/full/10.1056/NEJMoa1304369?for the citation Von Hoff DD, Ervin T, Arena FP, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med 2013. DOI: 10.1056/NEJMoa1304369.
?The peer-reviewed publication of the MPACT results in the?New England Journal of Medicine?further validates the importance of this treatment regimen,? said Markus Renschler, M.D., Corporate Vice President, Global Head of Hematology and Oncology Medical Affairs at Celgene Corporation. ?These results led to the U.S. Food and Drug Administration?s approval of ABRAXANE for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.?
In the MPACT (Metastatic?Pancreatic?Adenocarcinoma?Clinical?Trial) study, a Celgene-sponsored, open-label, randomized, international study, a total of 861 patients were randomized 1:1 (431 patients to the ABRAXANE/gemcitabine group and 430 patients to the gemcitabine group). Patients randomized to ABRAXANE/gemcitabine received ABRAXANE as an intravenous infusion over 30-40 minutes at a dose of 125 mg/m2 followed by gemcitabine as an intravenous infusion over 30-40 minutes at a dose of 1000 mg/m2 given on Days 1, 8 and 15 of each 28-day cycle. In the comparator treatment group, gemcitabine monotherapy was administered at a dose of 1000 mg/m2 given weekly for 7 weeks followed by a 1-week rest period in Cycle 1 and in Cycle 2 and onwards was administered on Days 1, 8 and 15 of a 28 day cycle. The primary endpoint for the study was overall survival. Secondary endpoints were progression-free survival and overall response rate determined by independent radiological review. Other endpoints included progression-free survival and overall response rate as determined by the investigator, and the safety and tolerability of the combination in this patient population.
Pancreatic cancer is the fourth-leading cause of cancer-related deaths in the United States and Europe. There are two main types of pancreatic cancer tumors: exocrine and neuroendocrine. Adenocarcinoma is a sub-type of exocrine tumors and accounts for about 95% of cancers of the pancreas. More than half of patients with pancreatic cancer are diagnosed after their cancer has already spread. The average life expectancy after diagnosis with metastatic disease is only three months.
ABRAXANE is an albumin-bound form of paclitaxel that is manufactured using patented?nab??technology. ABRAXANE is formulated with albumin, a human protein, and is free of solvents.
In the United States, ABRAXANE was first approved in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ABRAXANE has been globally approved in more than forty countries for the treatment of metastatic breast cancer (MBC).