Erbitux Prolongs Survival in Head and Neck Cancer

Erbitux, the ImClone Systems Inc. drug at the center of the insider trading scandal that ensnared Martha Stewart, controlled head and neck cancer better than radiation and helped some patients live longer, researchers said on Saturday.

Tumors were less likely to spread in patients with head and neck cancer who took Erbitux in combination with radiation than those treated with radiation alone, said Dr. James Bonner the University of Alabama at Birmingham. They also lived longer. He said cancer did not spread below the collarbone in 69 percent of the 424 patients given Erbitux and radiation, compared with 59 percent receiving radiation alone. After two years, tumors had not spread in 56 percent of the Erbitux group, compared with 48 percent for the radiation-only patients, Bonner told a meeting of the American Society of Clinical Oncology. The patients had all already had their cancer spread locally, but preventing such tumors from spreading below the collarbone is important because they are more fatal once they migrate beyond the head and neck region. But considerably more people in the Erbitux group developed rashes or allergic reactions than those treated only with radiation — typical side-effects of drugs like Erbitux. Bonner said 57 percent of the Erbitux group were still alive three years after treatment, compared with 44 percent of those receiving only radiation. Patient follow-up in the 5-year international study, conducted along with ImClone’s European partner Merck KGaA is still ongoing, Imclone said. Erbitux, the first commercial product for New York-based Imclone, won long-delayed approval from U.S. regulators in February for treatment of colon cancer in combination with chemotherapy for patients who have not been helped by or could not tolerate other forms of therapy. The approval came with ImClone co-founder and former Chief Executive Sam Waksal in prison for insider trading and style guru Stewart awaiting sentencing for lying to investigators looking into suspicious timing of her sale of nearly 4,000 ImClone shares in late 2001 just before the Food and Drug Administration rejected an application to review Erbitux. ImClone, which co-markets Erbitux with New York-based drugmaker Bristol-Myers Squibb Co., also will present data at the meeting from small mid-stage clinical studies of Erbitux for the most common form of lung cancer and as a first-line treatment for colon cancer. The drug works by blocking a protein called epidermal growth factor that is believed to help tumor cells reproduce. “We plan to discuss the head-and-neck cancer data with the FDA,” Bristol-Myers spokeswoman Kathy Baum said on Saturday, but she declined to say when the company and ImClone might seek U.S. approval to market Erbitux for the disease.(Source: American Society of Clinical Oncology: Reuters Health News: Ransdell Pierson: June 2004)