ImClone Loses an Indication

Last week biopharmaceutical firm ImClone Systems (Nasdaq: IMCL) reported that its lead cancer compound Erbitux failed in a phase 3 study as a front-line treatment for metastatic pancreatic cancer. The details of the study are still being interpreted, but ImClone announced that Erbitux, in combination with a leading chemotherapeutic agent, did not improve overall survival.

OSI Pharmaceuticals' (Nasdaq: OSIP) Tarceva is the only targeted therapy indicated for use in pancreatic cancer. What makes the Erbitux results somewhat surprising is that it's in the same Epidermal Growth Factor Receptor (EGFR) inhibitor class of therapies and, in earlier trials, showed a benefit in this patient population. Pancreatic cancer is a devastating disease, and those afflicted with it have a severe medical need unmet by the pharmaceutical industry. Success in this indication would have brought meaningful revenue to ImClone and partner Bristol-Myers Squibb (NYSE: BMY).  

No targeted therapy is going to be a wonder drug that works against all cancer types, since the composition of solid tumors varies by type of cancer and between people. This negative outcome in Erbitux as a treatment for front-line pancreatic cancer is a good example of this adage, and it was just two weeks ago that ImClone announced contrasting study results that Erbitux was successful in the front-line setting for head and neck cancer.

Erbitux is now at least temporarily blocked out of on-label sales in pancreatic cancer, but investors in shares of ImClone will be inundated with new Erbitux data that could improve the drug's label in the next several months with the all-important American Society of Clinical Oncology meeting coming up in the beginning of June.

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Fool contributor Brian Lawler does not own shares of any company mentioned in this article.