ImClone Systems Incorporated and Bristol-Myers Squibb Company have announced that a phase III study of Erbitux (cetuximab) plus gemcitabine (a chemotherapy) in patients with locally advanced unresectable or metastatic pancreatic cancer did not meet its primary endpoint of improving overall survival.

Conducted by the Southwest Oncology Group (SWOG), a cancer centre network sponsored by the National Cancer Institute, the open-label, randomised study compared Erbitux plus gemcitabine to gemcitabine alone in more than 700 patients with pancreatic cancer in the first-line treatment setting. The study was conducted in centres throughout the United States and Canada. It was completed in a significantly shorter time than projected, providing a timely answer to an important research question. SWOG has informed ImClone and Bristol-Myers Squibb that the primary study endpoint of statistically improving overall survival was not met. The three parties -- SWOG, ImClone, and Bristol-Myers Squibb -- will engage in joint efforts to fully interpret these results.

"This study was designed to examine the phase II results we previously observed for Erbitux in patients with pancreatic cancer," stated Eric K Rowinsky, chief medical officer and senior vice president of ImClone Systems. "We still consider pancreatic cancer to be of the utmost priority and we intend to pursue additional evaluations with Erbitux including a pilot study of Erbitux and bevacizumab with or without gemcitabine, as well as our pipeline agents, to improve the outcome for patients with pancreatic cancer."

"Pancreatic cancer is a devastating disease with few effective treatment options, and it is unfortunate that the use of Erbitux in this trial has not demonstrated the benefit it has shown in other tumours," said Martin Birkhofer, vice president, oncology global medical affairs, Bristol-Myers Squibb. "We are anxious to understand these data in greater detail and are committed to exploring the potential benefits that Erbitux may provide to cancer patients."

Erbitux (Cetuximab), in combination with radiation therapy, is indicated for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. Erbitux as a single agent is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum-based therapy has failed.

Erbitux is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma (mCRC) in combination with irinotecan for patients who are refractory to irinotecan-based chemotherapy, and as a single agent for patients who are intolerant to irinotecan-based therapy. The effectiveness of Erbitux for the treatment of EGFR-expressing mCRC cancer is based on objective response rates. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Erbitux for the treatment of EGFR-expressing mCRC.