Evofosfamide Receives FDA Fast Track Designation for Pancreatic Cancer Treatment

Strategic Insights -

The US Food and Drug Administration (FDA) has granted Fast Track designation to Merck KGaA's investigational compound evofosfamide for the treatment of previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer. Evofosfamide is an investigational hypoxia-activated prodrug that is thought to be activated under severe tumor hypoxic conditions, a feature of many solid tumors. This designation will help to facilitate the timely development of this high-priority program for the biopharmaceutical business of Merck KGaA.

Key Takeaways:

  • Evofosfamide is currently in Phase III trials for the treatment of pancreatic cancer and has received the second indication for Fast Track designation from the FDA.
  • The compound is thought to be activated under severe tumor hypoxic conditions, a feature of many solid tumors.
  • Pancreatic cancer is a relatively uncommon but lethal cancer, ranking as the 12th most common cancer worldwide and the 7th most common cause of cancer-related death.
  • 93-95% of patients with pancreatic cancer die from their disease within 5 years, with little improvement seen in the survival of patients over the past 30 years.
  • Evofosfamide has also received Orphan Drug designation for the treatment of STS and pancreatic cancer and has been granted Fast Track designation for both STS and pancreatic cancer by the FDA.
  • The MAESTRO Phase 3 study is currently evaluating evofosfamide in combination with gemcitabine versus gemcitabine and placebo in patients with locally advanced unresectable or metastatic pancreatic cancer.
  • The biopharmaceutical business of Merck KGaA operates as EMD Serono in the United States and Canada.
  • Merck KGaA, Darmstadt, Germany, signed a global license and co-development agreement for evofosfamide with Threshold Pharmaceuticals, Inc. in February 2012.

Statistics:

  • 93-95% of patients with pancreatic cancer die from their disease within 5 years.
  • Pancreatic cancer is the 12th most common cancer worldwide and the 7th most common cause of cancer-related death.
  • 80-85% of patients with pancreatic cancer present with advanced, inoperable disease.
  • The biopharmaceutical business of Merck KGaA has more than 1,100 employees in the United States, with commercial, clinical, and research operations based in Massachusetts.

Sources:

  • Ferlay J, et al. Int J Cancer 2015;136(5):E359-86.
  • National Cancer Institute. SEER Stat Fact Sheets: Pancreas. Available at: Accessed: May 2015.
  • EUROCARE-4 database on cancer survival in Europe. Long-term survival expectations of cancer patients in Europe in 2000-2002. Available at: Accessed: May 2015.
  • Malik NK, et al. J Gastrointest Oncol 2012;3(4):326-34.
  • Loc WS, et al. World J Gastroenterol 2014;20(40):14717-25.