Story from ForbesThe news is another setback for Pfizer as it makes a big push into cancer drugs.
Pfizer has stopped entering new patients into the most advanced clinical trial of its experimental lung cancer drug because those who received it were more likely to suffer serious side effects and die.
The conclusions are not definitive. Patients enrolled in the study will continue to get the drug, figitumumab. Another phase three trial testing figitumumab with Tarceva, made by Roche and OSI Pharmaceuticals, will continue. A third late-stage trial of the drug has not yet started.
But the news is another setback for Pfizer as it makes a big push into cancer drugs, an effort that led it to create a new business unit and push more than a dozen experimental medicines into human testing. GlaxoSmithKline and AstraZeneca have been making a similarly broad push into developing such medicines.
One trial of Sutent, Pfizer's marketed cancer pill, failed in April to help breast cancer patients better than Xeloda, another pill developed by Roche. A clinical trial of axitinib, a drug that Pfizer had high hopes for in pancreatic cancer, was stopped because it was unlikely to show a benefit for the disease. Cancer remains one of the hottest areas for research at Pfizer, which is struggling to come up with new drugs as it faces the patent expiration of its cholesterol-lowerer Lipitor, the biggest drug ever, in a year. Pfizer is also in the midst of closing its $60 billion acquisition of rival Wyeth.
Figitumumab should be an especially promising entrant. It is an antibody designed to block the insulin-like growth factor 1. John Mendelsohn, president of M.D. Anderson Cancer Center and co-inventor of Erbitux, sold by Eli Lilly and Bristol-Myers Squibb, has called it "the second big pathway that seems to be important for growth in many cancer cells," after the epidermal growth factor (EGF) pathway targeted by Erbitux and Tarceva, made by Roche and tiny OSI Pharmaceuticals.
Merck is in the midst of testing its own IGF-1 drug in colon cancer, but Pfizer had been in the lead with its lung cancer studies. But the current study tested as a first choice in the patients who shouldn't get Roche's Avastin because of their difficult types of tumors.
Pfizer says an independent Data Safety Monitoring Committee took a routine look at the results for the trial and found that patients who were receiving figitumumab with carboplatin and Taxol were experiencing more "serious adverse events, including fatalities" than those who were getting carboplatin and Taxol alone. The decision was made to stop entering new patients in the trial. Pfizer and the committee will conduct "a thorough review."
The news of the cancellation was first reported on the blog of Sally Church, a management consultant to the pharma and biotech industry.
Pfizer has stopped entering new patients into the most advanced clinical trial of its experimental lung cancer drug because those who received it were more likely to suffer serious side effects and die.
The conclusions are not definitive. Patients enrolled in the study will continue to get the drug, figitumumab. Another phase three trial testing figitumumab with Tarceva, made by Roche and OSI Pharmaceuticals, will continue. A third late-stage trial of the drug has not yet started.
But the news is another setback for Pfizer as it makes a big push into cancer drugs, an effort that led it to create a new business unit and push more than a dozen experimental medicines into human testing. GlaxoSmithKline and AstraZeneca have been making a similarly broad push into developing such medicines.
One trial of Sutent, Pfizer's marketed cancer pill, failed in April to help breast cancer patients better than Xeloda, another pill developed by Roche. A clinical trial of axitinib, a drug that Pfizer had high hopes for in pancreatic cancer, was stopped because it was unlikely to show a benefit for the disease. Cancer remains one of the hottest areas for research at Pfizer, which is struggling to come up with new drugs as it faces the patent expiration of its cholesterol-lowerer Lipitor, the biggest drug ever, in a year. Pfizer is also in the midst of closing its $60 billion acquisition of rival Wyeth.
Figitumumab should be an especially promising entrant. It is an antibody designed to block the insulin-like growth factor 1. John Mendelsohn, president of M.D. Anderson Cancer Center and co-inventor of Erbitux, sold by Eli Lilly and Bristol-Myers Squibb, has called it "the second big pathway that seems to be important for growth in many cancer cells," after the epidermal growth factor (EGF) pathway targeted by Erbitux and Tarceva, made by Roche and tiny OSI Pharmaceuticals.
Merck is in the midst of testing its own IGF-1 drug in colon cancer, but Pfizer had been in the lead with its lung cancer studies. But the current study tested as a first choice in the patients who shouldn't get Roche's Avastin because of their difficult types of tumors.
Pfizer says an independent Data Safety Monitoring Committee took a routine look at the results for the trial and found that patients who were receiving figitumumab with carboplatin and Taxol were experiencing more "serious adverse events, including fatalities" than those who were getting carboplatin and Taxol alone. The decision was made to stop entering new patients in the trial. Pfizer and the committee will conduct "a thorough review."
The news of the cancellation was first reported on the blog of Sally Church, a management consultant to the pharma and biotech industry.
No comments:
Post a Comment