Astrazeneca 期望在得到“令人激动”的Ii期试验结
LONDON (Reuters Health) - AstraZeneca confirmed on Thursday plans to file for marketing approval of its potential blockbuster anticancer drug Iressa by the end of this year following "exciting" phase ll trial results in advanced non-small-cell lung cancer.
The trial involved 210 patients who had previously received one or two rounds of standard chemotherapy and had no other treatment options. They received either 250 mg or 500 mg of the epidermal growth factor receptor (EGRF) inhibitor Iressa daily, by mouth, on an outpatient basis.
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The results, presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics meeting in Miami, showed that 34% of patients taking the novel therapy survived without disease progression for at least four months.
The overall tumour response rate in the 210-patient trial was 18.7% and the overall disease control rate was 52.9%. The median time to improvement in disease-related symptoms was eight days. The drug also was well tolerated, investigators said.
, 百拇医药
"It is almost unprecedented to see such a high response rate with a new drug in such a difficult-to-treat subset of patients," said Jose Baselga, one of the lead investigators and chairman of the medical oncology service at Vall d'Hebron University Hospital in Barcelona.
"This is a big leap forward because it is a targeted therapy against a receptor that appears to be very important. It's elegant, it's new and the data we are reporting today shows it's working."
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George Blackledge, medical director in charge of oncology at AstraZeneca, told Reuters Health, "To have a measurable response rate of around 20%, and around 50% of the patients gaining dramatically demonstrable clinical benefit is very exciting. These are patients who would otherwise be dead."
He said that one patient's tumour had disappeared completely. In 20% of patients, the tumour shrank by more than 50%. In a further 30% of patients it shrank by up to 50%.
, 百拇医药
"The thing that has most impressed me is the improvement in symptoms," Blackledge added. "These are patients who are coughing up blood, they are short of breath, they are in pain. The improvement in symptoms was not only dramatic, it was fast. We have seen it within one week."
Blackledge estimated that at least 40% of solid tumours were potential targets for EGRF inhibitors. Baselga said that it could be as many as 70%. "We have a large number of trials ongoing in breast, prostate, colorectal and gastric cancers," Blackledge said.
, 百拇医药
He confirmed that AstraZeneca plans to file for marketing approval of Iressa for the treatment of advanced non-small-cell lung cancer in the United States and Japan by the end of this year using the non-randomised, phase II clinical trial data.
He said that the European filing would probably follow in 2003 because European regulatory authorities were "slightly more rigorous" and usually demanded randomised studies. However, the company was hoping the drug could be fast-tracked.
Results of large phase III trials in patients with non-small-cell lung cancer are expected in 2002, Blackledge said.
In Thursday trade on the London Stock Exchange, shares of AstraZeneca closed up 80 pence at 3181., http://www.100md.com
The trial involved 210 patients who had previously received one or two rounds of standard chemotherapy and had no other treatment options. They received either 250 mg or 500 mg of the epidermal growth factor receptor (EGRF) inhibitor Iressa daily, by mouth, on an outpatient basis.
, http://www.100md.com
The results, presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics meeting in Miami, showed that 34% of patients taking the novel therapy survived without disease progression for at least four months.
The overall tumour response rate in the 210-patient trial was 18.7% and the overall disease control rate was 52.9%. The median time to improvement in disease-related symptoms was eight days. The drug also was well tolerated, investigators said.
, 百拇医药
"It is almost unprecedented to see such a high response rate with a new drug in such a difficult-to-treat subset of patients," said Jose Baselga, one of the lead investigators and chairman of the medical oncology service at Vall d'Hebron University Hospital in Barcelona.
"This is a big leap forward because it is a targeted therapy against a receptor that appears to be very important. It's elegant, it's new and the data we are reporting today shows it's working."
, http://www.100md.com
George Blackledge, medical director in charge of oncology at AstraZeneca, told Reuters Health, "To have a measurable response rate of around 20%, and around 50% of the patients gaining dramatically demonstrable clinical benefit is very exciting. These are patients who would otherwise be dead."
He said that one patient's tumour had disappeared completely. In 20% of patients, the tumour shrank by more than 50%. In a further 30% of patients it shrank by up to 50%.
, 百拇医药
"The thing that has most impressed me is the improvement in symptoms," Blackledge added. "These are patients who are coughing up blood, they are short of breath, they are in pain. The improvement in symptoms was not only dramatic, it was fast. We have seen it within one week."
Blackledge estimated that at least 40% of solid tumours were potential targets for EGRF inhibitors. Baselga said that it could be as many as 70%. "We have a large number of trials ongoing in breast, prostate, colorectal and gastric cancers," Blackledge said.
, 百拇医药
He confirmed that AstraZeneca plans to file for marketing approval of Iressa for the treatment of advanced non-small-cell lung cancer in the United States and Japan by the end of this year using the non-randomised, phase II clinical trial data.
He said that the European filing would probably follow in 2003 because European regulatory authorities were "slightly more rigorous" and usually demanded randomised studies. However, the company was hoping the drug could be fast-tracked.
Results of large phase III trials in patients with non-small-cell lung cancer are expected in 2002, Blackledge said.
In Thursday trade on the London Stock Exchange, shares of AstraZeneca closed up 80 pence at 3181., http://www.100md.com