ImClone Systems and Bristol-Myers Squibb announced the results of several clinical studies of ERBITUX, an IgG1 monoclonal antibody, presented at the American Society of Clinical Oncology (ASCO) 41st Annual Meeting.
“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,” said Eric Rowinsky, M.D., ImClone Systems Chief Medical Officer.
“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,” he added.
Data were presented from clinical studies exploring treatment of various stages of colorectal, head and neck, and ovarian cancers using ERBITUX either as a single agent or in combination with cytotoxic agents, including chemotherapy and radiation therapy. An article from TheStreet.com says:
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.
“Bristol-Myers Squibb and ImClone Systems are dedicated to the ongoing investigation of ERBITUX and to providing more treatment options for cancer patients in the future,” said Martin Birkhofer, M.D., Vice President, Oncology Global Medical Affairs, Bristol-Myers Squibb.
ImClone plans to file for approval of Erbitux as a head and neck cancer treatment by the end of 2005. The company had previously planned to do so in the second quarter.
Chris is a staff writer for murdok. Visit murdok for the latest ebusiness news.
