Days after posting positive data for the drug in head and neck cancer, ImClone Systems has suffered a setback after a late-stage trial of Erbitux in pancreatic cancer failed to meet its primary endpoint.
ImClone and partner Bristol-Myers Squibb announced that a Phase III study of Erbitux (cetuximab) plus a standard chemotherapy, Eli Lilly’s Gemzar (gemcitabine) in patients with locally advanced unresectable or metastatic pancreatic cancer did not meet its primary endpoint of improving overall survival.
The trial, which was conducted by the Southwest Oncology Group, compared Erbitux plus gemcitabine to gemcitabine alone in more than 700 patients with pancreatic cancer in the first-line treatment setting and was completed in a significantly shorter time than projected, “providing a timely answer to an important research question,” ImClone said. The firm’s chief medical officer, Eric Rowinsky, was not downbeat, however, and said “we still consider pancreatic cancer to be of the utmost priority and we intend to pursue additional evaluations with Erbitux,” including a study of the drug and Roche’s Avastin (bevacizumab) with or without gemcitabine, “as well as our pipeline agents, to improve the outcome for patients with pancreatic cancer."
Investors were less upbeat about the news and ImClone shares ended the day down 6.4% at $39.64. Erbitux, which is sold by Merck KGaA outside North America, had sales of $1.1 billion in 2006, and is approved as a treatment for colorectal, as well as advanced head and neck cancer, and ImClone is keen to get another indication under its belt to drive revenues of its only marketed product.
This year in the USA, nearly 34,000 people will be diagnosed with cancer of the pancreas and it accounts for about 6% of all cancer deaths, or about 32,000 deaths per year. If it gets approval for this indication, Erbitux would go head to head with Roche’s Tarceva (erlotinib).