Swiss drug firm Roche said on Tuesday it had halted the clinical trial of Avastin, made by its U.S. unit Genentech , in combination with chemotherapy as a first-line treatment for advanced pancreatic cancer.
California-based Genentech, which is majority owned by Roche, said the late-phase study of the drug did not meet its primary endpoint for overall survival.
"We are disappointed in these results and will be evaluating the data to understand potential reasons why Avastin did not add a clinical benefit in this trial," said Hal Barron, chief medical officer for Genentech, in a statement.
Eduard Holdener, head of development at Roche, echoed his comments in a separate statement.
Pancreatic cancer is one of the most aggressive forms of cancer and one of the most difficult to treat.
Avastin is already one of the top sellers for Roche and Genentech and is one of their biggest new drug hopes. The companies are looking to widen its use into a range of other applications.
Genentech is investigating the use of potential blockbuster Avastin in 25 cancer types including colorectal, breast, lung, pancreatic, ovarian, renal cell carcinoma, and prostate cancer.
Roche shares were down 0.66 percent at 195.60 francs at 1215 GMT, in line with the European pharma shares <.SXDP>.
The Phase III trial was stopped on the recommendation of an independent monitoring board based on an interim analysis.
"The study was not stopped due to safety events, and no new safety concerns related to Avastin were observed in this trial," Roche said in a media statement.
Existing regulatory filings and approvals in colorectal, lung and breast cancer were not affected, the company said.
Analyst Denise Anderson at Kepler Equities in Zurich said this particular, potential use of Avastin represented only a fraction of the drug's potential.
TOO OPTIMISTIC?
"It doesn't mean that the drug doesn't work in pancreatic cancer, it just means that for that group, patients with that combination, it does not improve overall survival ... which is also a difficult -- the most challenging -- end-point to achieve," she said.
Equity analysts at Dresdner Kleinwort Wasserstein said the results could cause some investors to review their hopes for Avastin.
"It highlights the fact that Avastin is not likely to work in all cancers," Dresdner analysts said in a note. "We believe investors may start to reassess some of the very high long-term growth forecasts for the drug as potentially too optimistic."
In Europe, Avastin was approved in early 2005 and in the United States in 2004 for first-line treatment of patients with advanced colorectal cancer.
Avastin was filed in April this year in the United States for the most common form of lung cancer. In May, Avastin was filed in the U.S. for the treatment of women with advanced breast cancer, the company said.
California-based Genentech, which is majority owned by Roche, said the late-phase study of the drug did not meet its primary endpoint for overall survival.
"We are disappointed in these results and will be evaluating the data to understand potential reasons why Avastin did not add a clinical benefit in this trial," said Hal Barron, chief medical officer for Genentech, in a statement.
Eduard Holdener, head of development at Roche, echoed his comments in a separate statement.
Pancreatic cancer is one of the most aggressive forms of cancer and one of the most difficult to treat.
Avastin is already one of the top sellers for Roche and Genentech and is one of their biggest new drug hopes. The companies are looking to widen its use into a range of other applications.
Genentech is investigating the use of potential blockbuster Avastin in 25 cancer types including colorectal, breast, lung, pancreatic, ovarian, renal cell carcinoma, and prostate cancer.
Roche shares were down 0.66 percent at 195.60 francs at 1215 GMT, in line with the European pharma shares <.SXDP>.
The Phase III trial was stopped on the recommendation of an independent monitoring board based on an interim analysis.
"The study was not stopped due to safety events, and no new safety concerns related to Avastin were observed in this trial," Roche said in a media statement.
Existing regulatory filings and approvals in colorectal, lung and breast cancer were not affected, the company said.
Analyst Denise Anderson at Kepler Equities in Zurich said this particular, potential use of Avastin represented only a fraction of the drug's potential.
TOO OPTIMISTIC?
"It doesn't mean that the drug doesn't work in pancreatic cancer, it just means that for that group, patients with that combination, it does not improve overall survival ... which is also a difficult -- the most challenging -- end-point to achieve," she said.
Equity analysts at Dresdner Kleinwort Wasserstein said the results could cause some investors to review their hopes for Avastin.
"It highlights the fact that Avastin is not likely to work in all cancers," Dresdner analysts said in a note. "We believe investors may start to reassess some of the very high long-term growth forecasts for the drug as potentially too optimistic."
In Europe, Avastin was approved in early 2005 and in the United States in 2004 for first-line treatment of patients with advanced colorectal cancer.
Avastin was filed in April this year in the United States for the most common form of lung cancer. In May, Avastin was filed in the U.S. for the treatment of women with advanced breast cancer, the company said.
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