• 12/17/2004
  • Rachael Myers Lowe
  • www.cancerpage.com

Disappointing clinical trial results lead drug maker AstraZeneca to stop promoting its targeted lung cancer drug Iressa (gefitinib). The company advised patients who are currently taking the drug to talk to their doctor as soon as possible. Those who want to continue taking Iressa will continue to get it, the company said.

“It is our intention to continue to provide the product” to those who want it, Mary Lynn Carver, AstraZeneca’s director of oncology information, told cancerpage.com.

The company announced today that initial analysis of a large clinical trial involving nearly 1700 patients shows that Iressa “failed to significantly prolong survival in comparison to placebo” in the overall population or in patients with cancer.

“This is a huge surprise to the oncology community, to the FDA and to ourselves,” Carver said.

In a letter to doctors posted on the AstraZeneca USA web site today, the company suggests physicians prescribing Iressa consider other options:

“In light of positive survival data with other agents including another oral EGFR inhibitor, AstraZeneca urges you to consider other treatment options in the recurrent non-small cell lung cancer patient population.”

Carver said the company was moving quickly to inform doctors about the test results because of the patients they treat. “The patients they are treating are highly refractory advanced lung cancer patients with only weeks to live in some cases,” she said.

In the US, Iressa was approved as a third-line treatment for advanced non-small cell lung cancer patients only after two more conventional therapies have failed. Since its introduction, about 200,000 patients have been treated with the drug worldwide. In the US, some 127,000 prescriptions have been written since was approved in May 2003.

Carver says researchers expected to see an overall survival benefit. Previous research has shown the drug causes tumors to shrink in about 10% of the cases, a finding confirmed in this trial. But, the more significant finding is that Iressa did not offer any significant survival benefit. The company is continuing to study the research data.

“We clearly know Iressa benefits some patients. We’ve seen some dramatic results,” Carver added.

In particular, investigators want to see if they can better identify those patients who might benefit from Iressa. Research earlier this year found that patients with non-small-cell lung cancer whose tumor had a mutation in the epidermal growth factor receptor (EGFR) responded to the drug while patients whose tumors did not have this mutation did not.

Numerous clinical trials are currently underway evaluating Iressa’s effectives either taken alone or in combination with chemotherapy against several cancer types including head and neck cancers, ovarian cancer, breast cancer, and brain cancer.

Iressa is a pill taken once a day. It costs about $1800 a month, the company says. It is included in a multimillion dollar demonstration project of oral cancer drugs for Medicare beneficiaries launched by the Centers for Medicare and Medicaid Services earlier this year.