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%.