Lilly Says Anticancer Drug Prolonged Lives of Patients

By JOHANNA BENNETT

DOW JONES NEWSWIRES

ORLANDO, Fla. -- Pharmaceutical giant Eli Lilly & Co.'s experimental chemotherapy drug Alimta took a step closer to becoming the first effective treatment for thousands suffering from a rare and insidious cancer caused by exposure to asbestos.

Results from a pivotal clinical trial released Monday showed that patients treated with Lilly's drug for a cancer of the lung's lining known as malignant pleural mesothelioma lived longer, endured less pain and breathed easier than patients treated with standard chemotherapy.

The study discussed at the American Society of Clinical Oncology's annual meeting in Orlando, Fla., breaks new ground, researchers said. Alimta is the first drug shown to prolong the life expectancy of patients suffering from what is an especially fatal form of cancer that has been resistant to treatment.

"This is the first time we have ever documented an improvement in mesothelioma survival," said lead investigator Dr. Nicholas Vogelzang, director of the University of Chicago Cancer Research Center, during a news conference.

Alimta could hold promise for thousands of workers in the construction and shipbuilding industries around the world who handled asbestos and could contract mesothelioma.

The disease results in tumors, usually caused by asbestos fibers lodged in the lung, which attach to the lung lining and chest wall. Over time, the tumors squeeze and compress the lung, making it difficult and painful to breathe.

Alimta is key to Lilly's pipeline, especially its cancer program, which is now led by the chemotherapy drug Gemzar. The company recently lowered its financial projections for this year, citing delays in the release of two new drugs and slow sales of the sepsis drug Xigris.

Lilly had expected to release Cialis, for male erectile dysfunction, and atomexetine, for attention-deficit hyperactivity disorder, this year. Lilly now expects the two drugs to be released in 2003.

The company is negotiating with the U.S. Food and Drug Administration to gain fast-track approval for Alimta as a treatment for mesothelioma. It is expected to hit the market next year. The drug also is being tested as a possible treatment for lung, pancreatic and colorectal cancer.

After Gemzar, this will be our second cancer drug," said Dr. Paolo Paoletti, executive director of Lilly's cancer drug program. "It is fundamental for our oncology program.

Mesothelioma is rare -- the U.S. Centers for Disease Control recorded just 706 cases in the U.S. in 1980 -- but the numbers are rising. A conservative estimate is that an average of 2,500 to 3,500 new cases are reported every year.

Some studies predict the disease will peak in 2010 as workers who handled asbestos in the 1960s and 1970s are being diagnosed 20 to 40 years later.

Treating mesothelioma has always been difficult. Because the cancer infests the lung's lining, surgery and radiation aren't options. And the tumors have always been resistant to drug therapies.

But Alimta is a different type of chemotherapy drug. Like many cancer therapies, it is designed to prevent cancer cells from growing by blocking the enzymes that allow the cell's DNA and RNA to replicate. But while other drugs block just one enzyme, Alimta blocks all three.

Researchers happened upon its effectiveness against mesothelioma during early studies into the drug's use against hard-to-treat cancers.

"Regardless of the fact that it is a rare cancer, we felt obligated to go forward," Dr. Paoletti said.

*** POSTED ON MAY 20, 2002 ***