West Coast Editor
By backing out of development deal with UCB SA for the cancer drug CDP-791, ImClone Systems Inc. gains time and resources to work on its own blocker of vascular endothelial growth factor receptor-2, slated to finish Phase I trials in the first half of this year.
New York-based ImClone said at the time of signing the UCB deal in the summer of 2005 that the firm would decide within about five years whether to go ahead with CDP-791 (which also blocks VEGFR-2) or push IMC-1121B instead. (See BioWorld Today, Aug. 17, 2005.)
Now, ImClone has made its move, based on data from the ongoing Phase I study, which has enrolled 23 patients with advanced cancer. Two have shown partial responses and seven others have had stable disease for at least six months. Investigators reported the most severe adverse events (Grade 3) as anemia, increased blood amylase, headache, hypertension, proteinuria and vomiting.
ImClone still gets a royalty payment on sales of CDP-791, expected to report Phase IIa data from a non-small cell lung cancer trial shortly. Company officials could not be reached, but questions posed to them Tuesday during a conference sponsored in New York by Merrill Lynch suggested that many investors remain more focused on Erbitux.
The compound won approval three years ago for use with irinotecan in epidermal growth factor receptor-expressing, metastatic colorectal cancer patients who are refractory to irinotecan-based chemotherapy, and as a single agent for those intolerant to irinotecan. Last spring, the FDA cleared Erbitux for head and neck cancer, too. (See BioWorld Today, March 3, 2006.)
Earlier this month, ImClone offered Phase III with Erbitux in first-line metastatic colorectal cancer therapy, which met its primary endpoint - important news, given Amgen Inc.'s Vectibix (panitumumab). (See BioWorld Today, Jan. 11, 2007.)
Amgen's drug is the first EGFR inhibitor to show a statistically significant improvement in progression-free survival in patients who have failed standard chemotherapy. The Thousand Oaks, Calif.-based company wants to expand the Vectibix label for use as a second-line therapy and, eventually, first-line. Other EGFR-targeting cancer drugs include Tarceva (erlotinib, Genentech Inc. and OSI Pharmaceuticals Inc.) and Iressa (gefitinib, AstraZeneca plc), both for NSCLC.
Not so long ago, observers often likened an Erbitux/Iressa comparison to a Pepsi/Coke match, but that's starting to change, said Michael Bailey, vice president of commercial operations for ImClone.
"We've got to wait and see what the data show, but we believe the internal consistency, the repeated positive data we've seen with Erbitux, is starting to be clearly differentiated," he told attendees at the Merrill Lynch conference.
IMC-1121B did get a mention, though, and recent research backs its potential. Results from some experiments show that attacking neither VEGFR1 nor VEGFR2 by itself stops tumor growth, blocking them together could get the job done. (See BioWorld Today, Dec. 13, 2006.)
ImClone officials stressed multiple approaches and multiple product candidates, lined up in the historically troubled company's often-overlooked pipeline. With a raft of drugs, the firm is "bursting out of Phase I now," said Eric Rowinsky, chief medical officer.
"We're really gunning forward," he said. "We're not testing the waters with small Phase II studies when we know we already have proof of principle. It's hard to give time lines, but that's basically where we stand."
Rowinsky also responded to a question about the ongoing, 760-patient trial with Erbitux against pancreatic cancer, for which ImClone hopes to lock the database at the end of this quarter or the start of next. "We think we're almost there," he said.
"There aren't too many creative designs for a first line study" in that notoriously challenging indication, Rowinsky noted. Survival is the endpoint, since "really no other endpoint in pancreatic cancer [is] meaningful, because of the expectations in this terrible disease," he said, and "expectations should be great" if the tumors respond like colorectal cancer, but this has yet to be proven.
The Merrill Lynch conference runs through Thursday. ImClone's stock (NASDAQ:IMCL) closed Tuesday at $29.27, down 21 cents.