07:09 ET AZN AstraZeneca: Iressa yields mixed results for lung cancer trials (37.12)
Dow Jones reports that AZN's cancer drug Iressa yielded disappointing results when combined with chemotheraphy to treat lung cancer, but was effective for patients who had not received any other therapy.
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AstraZenaca's Iressa Drug Yields Disappointing Results Against Lung Cancer
Tuesday October 22, 3:59 am ET
Associated Press
NICE, France -- An experimental drug that targets cancer in an entirely new way has yielded disappointing results when combined with chemotherapy for lung- cancer patients, but experts remain convinced it has a role in fighting cancer.
The drug, called Iressa, was very impressive in early studies of lung-cancer patients who hadn't been helped by any other therapy.
However, it had no effect when combined with chemotherapy and given as first- line treatment to more than 2,000 patients in two large trials, researchers reported Monday.
Iressa, made by Anglo-Swedish drug maker AstraZeneca PLC , is being investigated for several types of cancer. Experts gathered in Nice for a meeting of the European Society of Medical Oncology said it's just a question of determining how best to use the drug and who should get it.
"The opinion is that drug does have a role," said Dr. Paul Bunn Jr., director of the University of Colorado Cancer Center.
Dr. Bunn, who wasn't connected with the studies, said that in hindsight, it seems the drug was rushed to large-scale testing.
"But I wouldn't fault them for having done it," said Dr. Bunn, who is president of the American Society of Clinical Oncology. "They saw before this trial, in the lab, that you could safely combine these agents, and they saw that there was a response in people who failed chemotherapy.
"It's possible that the negative results with the combination included some patients who benefited and some patients who had a detrimental effect from the combination," Dr. Bunn said.
Two trials of about 1,000 patients each were conducted. One was done in the U.S. using the chemotherapy combination most commonly used there. The other was conducted in Europe, with a slightly different combination of chemotherapy drugs.
Each trial divided patients into three groups. Everyone received chemotherapy. In addition, one group got 250 mg of Iressa daily, another got 500 mg and the third group received a dummy pill.
"The bottom line is there is not any difference in the outcome. The survival in the three ... is essentially identical," said Dr. David Johnson, who presented the U.S. results at the meeting.
The results of the European trial were the same.
Dr. Martine Piccart, head of chemotherapy at the Jules Bordet Institute in Brussels, said Iressa may be effective if patients are carefully selected. "I think we may find a subset of patients who benefit from this drug," Dr. Piccart said.
Dr. Johnson said that view isn't surprising.
"Every doctor who deals with lung cancer, who has used this drug, can name you at least one case that he or she has seen where the patient's tumor has nearly melted away. And these patients instantly feel better. You don't see this with any other drug that we use," said Dr. Johnson, deputy director of the Vanderbilt-Ingram Cancer Center in Nashville.
"Even if it's a rare event, it's so stunning when it occurs that each of us is kind of slack-jawed when it happens," Dr. Johnson said.
Since June 2000, some desperate lung cancer patients have been allowed to get Iressa on compassionate grounds. The drug has recently been approved in Japan for lung cancer patients who have exhausted all other options.
biz.yahoo.com
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AstraZeneca Loses UK Appeal On Omeprazole Patents
DOW JONES NEWSWIRES
Edited Press Release
LONDON -- AstraZeneca PLC (AZN) Tuesday announced the Court of Appeal in London has denied its request for a re-trial after an earlier decision of the U.K.'s Patents Court in a dispute with the generic pharmaceutical companies, Arrow Generics Limited - acting through Cairnstores Limited - and Generics U.K. Limited, about formulation patents for omeprazole.
Omeprazole is the active substance used in Losec, a treatment for acid-related disorders, such as peptic ulcers.
The Court of Appeal refused to allow a re-trial due to the bias shown by the Patents Court judge in the original hearing, and the decision in March of the Patents Court of the High Court Chancery Division, which declared the formulation patents - EP 247 983 and EP 496 437 - invalid due to obviousness, was affirmed.
The U.K. represented 4.3% of Losec's worldwide sales in 2001.
Updated October 22, 2002 6:57 a.m. EDT |
