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NEW ORLEANS -- ImClone Systems' ( IMCL) cancer drug Erbitux, when added to radiation therapy, nearly doubles survival for patients with advanced head and neck cancer, according to results from a phase III study made public Saturday at the annual meeting of the American Society of Clinical Oncology (also known as ASCO).

It's not yet clear whether the positive data from this study will prompt ImClone and partner Bristol-Myers Squibb ( BMY) to seek an expansion of Erbitux's label from the Food and Drug Administration. But the fact that Erbitux appears to help some patients with head and neck cancer live longer -- the most important test of a cancer drug's efficacy, generally speaking -- will likely convince oncologists to begin using the drug "off label" to treat this form of cancer. Erbitux is already approved and marketed as a treatment for advanced colon cancer.

There are about 40,000 people in the U.S. diagnosed each year with head and neck cancer. Of these, about 30% are currently treated with radiation alone and would therefore be candidates for the addition of Erbitux, according to a recent survey from investment bank SG Cowen. This equates to a $150 million market opportunity for ImClone, estimates Cowen, adding that sales could quadruple if doctors use Erbitux more broadly in head and neck cancer, just as they have started to do in colon cancer. (Cowen doesn't have an investment banking relationship with ImClone.)

The 424 patients enrolled in this phase III study were all diagnosed with advanced head and neck cancer that had not yet spread, or metastasized, to other parts of the body. About half the patients were treated with a combination of high-dose radiation plus Erbitux, the remaining half with high-dose radiation alone.

Patients receiving radiation and Erbitux had a median survival of 54 months, compared to a median survival of 28 months for patients receiving radiation alone. These results were statistically significant.

Furthermore, patients in the Erbitux arm had two- and three-year survival rates of 62% and 57%, respectively, compared to respective two- and three-year survival rates of 55% and 44% for patients in the radiation-only arm.

"The use of cetuximab Erbitux and radiation therapy may become an excellent choice of therapy for this group of patients," Dr. James Bonner, a radiation oncologist at the University of Alabama and the lead investigator of the study, said in a statement. "Future studies should be performed to examine combinations of chemotherapy, radiation therapy and cetuximab Erbitux."

Saturday's data presentation was conducted by ASCO for journalists as part of a media briefing highlighting medical advances in lung and head and neck cancer. A full airing of this Erbitux data in front of the attendees at ASCO's annual meeting is scheduled for Tuesday.

One hitch in this Erbitux study is that it was started in 1999, and since then, doctors have altered the way they treat patients with so-called front-line, advanced head and neck cancer. Instead of using radiation alone, the standard of care is now the combination of radiation and chemotherapy. Since the study did not include the use of chemotherapy, ImClone may find it difficult to use the study as the basis for a new FDA approval filing.

Still, given the survival benefit driven by Erbitux, doctors are likely to use the drug "off label," especially in head and neck cancer patients who can't tolerate chemotherapy. Some doctors may also assume that if radiation and chemotherapy work, then a triple combination of radiation, chemotherapy and Erbitux will work even better. There has been data presented at past ASCO meetings that showed evidence of Erbitux and chemotherapy working synergistically in head and neck cancer, just like it does in colon cancer.

Erbitux may also be an option as a standalone treatment for head and neck cancer patients who have exhausted all other medical options. Merck KGaA, the German drugmaker and ImClone's European partner, will be presenting midstage clinical data at ASCO investigating Erbitux's use as a monotherapy in these so-called refractory head and neck cancer patients.

ImClone is holding an investor meeting Sunday night, at which analysts are guaranteed to ask company executives about their regulatory strategy vis a vis Erbitux and head and neck cancer. If ImClone does seek a label expansion from the FDA, and approval is awarded, ImClone would receive a $250 million milestone payment from partner Bristol-Myers Squibb.

ImClone shares closed Friday at $72.49, down 47 cents, or 0.64%, while Bristol-Myers finished at $25.47, down 30 cents or 1.19%.

Adam Feuerstein writes regularly for RealMoney.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. He invites you to send your feedback to adam.feuerstein@thestreet.com.Adam Feuerstein writes regularly for RealMoney.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. He invites you to send your feedback to adam.feuerstein@thestreet.com.

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