ImClone Systems: Erbitux Takes a Knock

ImClone Systems’ and Bristol-Myers Squibb’s Erbitux in combination with Eli Lilly’s Gemzar in patients with locally advanced unresectable or metastatic pancreatic cancer has failed to meet its primary endpoint in a Phase III clinical trial. This comes as a setback following the recent announcement of the drug’s success in improving survival in head and neck cancer.

ImClone revealed that data from the 700-patient, open-label, randomized trial of Erbitux in combination with Gemzar compared to Gemzar alone in locally advanced unresectable or metastatic pancreatic cancer did not meet the primary study endpoint of statistically improving overall survival. Previous Phase II data indicated that the combination of Erbitux and Gemzar generated an overall response rate of 12% and disease stabilization rate of 39%. Median time to progression was 16 weeks with Erbitux, in comparison to nine weeks as seen with standard gemcitabine therapy.

Erbitux is already FDA approved for the dual indications of locally/regionally advanced squamous cell carcinoma of the head and neck in combination with radiotherapy and as a single agent for the second-line treatment of recurrent or metastatic disease following the failure of platinum-based therapy. The Erbitux/platinum-based chemotherapy combination also confers enhanced survival in the treatment of recurrent or metastatic head and neck cancer.

Erbitux is also indicated for the treatment of 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.

With approximately 33,700 individuals expected to be diagnosed with pancreatic cancer this year, and with the disease accounting for approximately 6% of all cancer deaths, there is a significant growth opportunity for a pharmaceutical company which can develop an improved therapy to Lilly’s Gemzar or Roche’s Tarceva.

However, at present, the inability of Erbitux to meet its clinical endpoint in the treatment of this disease has certainly delayed ImClone and BMS’s chance at entering this potentially lucrative market. Furthermore, this has knocked the share prices of both companies which had increased following recent upbeat news in head and neck cancer.