ImClone Hopes for Broader Erbitux Role

At this year's ASCO meeting, the company presented results from a variety of studies.
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ImClone Systems

(IMCL)

, the biotech firm that earlier this decade was known more for the Sam Waksal-Martha Stewart trading scandal than drug development, showed again this week that it's undoing what it can of the past and moving forward with its tumor fighter Erbitux.

The results from a variety of studies are being presented at this year's American Society of Clinical Oncology annual meeting, and the company's trials indicate that it has high hopes for its product in a number of settings. Data were presented at ASCO from clinical studies exploring the treatment of various stages of colorectal, head and neck, and ovarian cancers using Erbitux either alone or with cytotoxic agents, including chemotherapy and radiation therapy.

One study discussed by researchers involved the findings of a Phase II trial of Erbitux and Avastin, with or without irinotecan, in 81 patients with metastatic colorectal cancer. Of 41 patients who received the Erbitux, Avastin and irinotecan combination, 37% had a partial response, and the median time to progression was 7.9 months. For 40 patients who received Erbitux and Avastin alone, 20% of patients had a partial response and the median time to progression was 5.6 months.

Separately, a Phase II study evaluated Erbitux in combination with Folxfox-4 as first-line treatment in patients with metastatic colorectal cancer. In a preliminary analysis of 42 patients, 10% had a complete response, 71% had a partial response, and 17% had stable disease. Median progression-free survival was 12.3 months.

A retrospective subgroup analysis evaluated 171 patients with hypopharyngeal and laryngeal carcinoma who were enrolled in a Phase III trial of 424 patients with advanced squamous-cell carcinoma of the head and neck. The study evaluated the addition of Erbitux to high-dose radiation vs. radiation alone, to evaluate the primary endpoint of locoregional control and the secondary endpoint of overall survival.

The subgroup analysis attempted to determine the rates of organ preservation. Of the 93 patients receiving Erbitux plus radiation, larynx preservation rates were 90% at two years and 87% at three years. For the 78 patients receiving radiation therapy alone, larynx preservation rates were 80% at two years and 77% at three years. ImClone said that because the study hadn't been designed to assess organ preservation, the results weren't statistically significant.

ImClone has said it expects to file for approval of Erbitux as a treatment for head and neck cancer by the end of the year. The company recently pushed back the expected filing date from its previous target of the second quarter of this year.

Another Phase II study examined the addition of Erbitux to standard chemotherapy with paclitaxel and carboplatin as a first-line treatment of advanced ovarian, primary peritoneal and fallopian tube cancer. The primary endpoint was progression-free survival. Preliminary data were reported for the first 27 patients to complete six cycles of initial treatment.

For the 12 patients with stage III cancer whose tumor was completely removed by surgery, 91.7% achieved a clinical complete response. Of the nine patients with stage III disease whose tumors could not be completely removed, 44.4% saw a clinical complete response. Six patients had stage IV disease, and four of them could be evaluated for efficacy. Of the four, two achieved a clinical complete response.

"Clinical trial results observed in combinations of Erbitux with widely used cancer treatments improve our understanding of where to focus our future study of this antibody," Eric Rowinsky, chief medical officer of ImClone, said in a press release. "Our long-term commitment to developing Erbitux in multiple indications will include pivotal or exploratory studies of Erbitux with other targeted therapies in colorectal, lung, pancreatic and ovarian cancers in addition to our ongoing Phase III studies with chemotherapy."

Erbitux belongs to a class of drugs that target epidermal growth factor receptors, which are abnormal in cancerous cells. By targeting the EGFRs and inhibiting cancer cell replication, these drugs can inhibit tumor growth. Erbitux is currently approved for treating EGFR-expressing metastatic colorectal cancer.

In premarket trading Monday, shares of ImClone were up 56 cents to $33.91.