By Elizabeth Lopatto
May 30 (Bloomberg) -- Eli Lilly & Co.’s lung cancer drug Alimta may help lengthen lives of patients whose disease is in remission, according to a study that may lead to a new treatment strategy for the malignancy.
Patients either took Alimta or a placebo every 21 days after their disease had been controlled with a standard therapy. People taking the drug lived 3 months longer overall than those on placebo, according to the Indianapolis-based company’s research being presented today at the American Society of Clinical Oncology meeting in Orlando, Florida.
More patients die from lung cancer than from any other form of the disease, according to the U.S. Centers for Disease Control and Prevention. The data have been submitted to U.S. regulators and are under review for approval of the new use for Alimta, said Richard Gaynor, Lilly’s head of oncology. Alimta, which generated $1.15 billion in 2008 revenue, is approved in the U.S. as a first-choice therapy and as a second-line treatment after initial therapy fails.
“We think the concept of maintenance therapy is very exciting, the notion that some kinds of cancer may be a chronic disease,” said John Lechleiter, the chief executive officer of Lilly, in a telephone interview. “It’s exciting to think that there are some kinds of cancer where, while it isn’t eradicated, it might be contained.”
The drug’s use as maintenance therapy got the backing yesterday of a European Medicines Agency panel, Lilly said in a statement.
Living Longer
Overall, the study found patients who were not on a maintenance therapy lived 10.6 months, and Alimta patients survived 13.4 months. Those patients on placebo went 2.6 months without their cancer worsening, while people talking Alimta had 4.3 months before their cancer worsened.
“In lung cancer, these results are very dramatic,” said Richard Gaynor, Lilly’s head of oncology. “This is the first example where maintenance therapy worked really impressively. It’s a paradigm-changing study.”
The study also found that a subset of patients with types of cancer that originated in certain large cells in the lungs lived 5 months longer on Alimta than the comparison group. Patients who had so-called nonsquamous cell cancer survived 15.5 months, and went 4 months without worsening on the Lilly drug. Comparable placebo patients survived 10 months, and went 1.8 months without worsening.
Targeting Therapies
“We can create tremendous value by targeting therapies,” Lechleiter said. “That way the payer doesn’t waste their money and the patient and doctor don’t waste their time.”
Seamus Fernandez, an analyst for Leerink Swann, said Alimta has the potential to generate $1.5 billion in sales this year, and increase to $2.9 billion in 2015.
The impact of the study on Alimta prescriptions may be “limited,” because Alimta is increasingly the first treatment used in cancer, Fernandez wrote in a May 13 note to investors. The study didn’t have Alimta as the first treatment, and additionally, it may be difficult to convince patients to undergo longer chemotherapy cycles, Fernandez wrote.
About 85 to 90 percent of lung cancers are nonsmall cell, according to the American Cancer Society, an advocacy group. Between a quarter and a third of all lung cancers are squamous cell carcinomas, which begin in cells in the lungs that look like fish scales. Patients who had nonsmall cell lung cancers that didn’t start in the squamous cells did best on Alimta maintenance therapy.
Researchers said the most common side effects were fatigue and a disorder of the white blood cells. Other side effects, each found in less than 1 percent of patients, were nausea, vomiting and infection.
For Related News and Information:
To contact the reporter on this story: Elizabeth Lopatto in New York at elopatto@bloomberg.net.
Last Updated: May 30, 2009 11:00 EDT
HOME
