Positive Phase III results for Erbitux in first-line treatment of metastatic colorectal cancer support ImClone and cetuximab partner Bristol-Myers Squibb's efforts to better position the biologic as a competitor to Genentech's Avastin (bevacizumab) and Amgen's Vectibix (panitumumab).

ImClone reported Jan. 10 that Erbitux plus standard chemotherapy met the primary endpoint of increasing median duration of progression-free survival over chemotherapy alone in patients with previously untreated metastatic colorectal cancer.

Avastin already has a first-line colorectal cancer indication.

The Erbitux study, dubbed CRYSTAL, is a global Phase III study of 1,000 patients, conducted by Merck KGaA, ImClone's ex-North America partner for Erbitux. Data from the study will be presented at the American Society of Clinical Oncology meeting in June.

ImClone and Bristol were dealt a setback in November when one of two other Phase III trials, testing Erbitux in a second-line colorectal cancer indication, failed to meet its primary endpoint of overall survival (¹ Also see "Erbitux Colon Cancer Data “Encouraging,” ImClone Says" - Pink Sheet, 6 November, 2006.).

Vectibix was approved in September as a second-line colorectal cancer treatment, and initial sales figures for the oncologic have indicated it might be eroding Erbitux market share (² Also see "Bristol/ImClone Erbitux Sales Declining In Face Of Vectibix Launch" - Pink Sheet, 2 January, 2007.).

ImClone is testing Erbitux, an epidermal growth factor receptor inhibitor, in combination with Avastin, a vascular endothelial growth factor inhibitor, as well as with chemotherapies, for colorectal cancer, the company said.

Amgen also is testing its EGFR inhibitor Vectibix in combination with Avastin for a front-line colorectal cancer indication. Data from a Phase III study are expected early this year.

ImClone/Bristol and the Israeli firm Yeda have been involved in a protracted legal dispute over intellectual property related to the use of an EGFR inhibitor in combination with chemotherapy (³ Also see "Erbitux Patent Holder Yeda Responds to ImClone Suit" - Pink Sheet, 1 November, 2006.).

ImClone told "The Pink Sheet" DAILY that it is actively pursuing three strategies toward resolution: One option is an appeal seeking to overturn the lower court's decision that Yeda scientists own the patent in question. The second is to seek a declaratory judgment that the patent is invalid. And the third is "obviously to settle with Yeda," the company said.

Amgen opted to take a path more akin to ImClone's third option, acquiring a non-exclusive license to Yeda's patent in September (⁴ Also see "Amgen Licenses Erbitux-Related Patent After ImClone Court Loss" - Pink Sheet, 19 September, 2006.).

-Shirley Haley (s.haley@elsevier.com)

ImClone Reports Promising Erbitux First-Line Colorectal Cancer Results

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