May 30, 2009
 
AstraZeneca cancer pill works with chemo to slow tumors
By TOM RANDALL
Bloomberg News

AstraZeneca Plc's Zactima, the experimental lung cancer drug that failed in two small studies, helped slow the advance of tumors in a bigger test the drugmaker will use to seek U.S. marketing approval.
 
Adding Zactima to treatment with chemotherapy shrank tumors and reduced disease symptoms, the research found. It also lengthened the time before the cancer progressed to 17.3 weeks, compared with 14 weeks for those on chemotherapy only. Patients taking Zactima didn't live significantly longer.
 
The finding was reported today at the American Society of Clinical Oncology in Orlando. It makes Zactima the first pill to work with chemotherapy for advanced lung cancer patients who havenít been helped by initial treatments, researchers said.
 
AstraZeneca will apply for U.S. approval by the end of the month, the London-based drugmaker said. The drug may generate annual sales of $500 million a year by 2014, according to an April report by Bank of America Merrill Lynch in New York.
 
"For the first time, we are actually improving efficacy" for patients on chemotherapy, said Peter Langmuir, medical science director at AstraZeneca, in an interview before the conference. "For patients in second-line treatment, there are three agents approved; none of them has been shown to be any better than docetaxel," a form of chemotherapy.
 
The trial, called Zodiac, tested the drug in 1,391 patients.
 
If approved, Zactima would compete with Roche's Tarceva and Eli Lilly & Co.ís Alimta for patients in secondary treatment. Another study presented at ASCO found that Zactima was no better or worse than Tarceva when used alone. Zactima's advantage would be as a proven combination therapy, Langmuir said.
 
About 200,000 Americans are diagnosed with lung cancer each year and 160,000 die from it, according to the U.S. Centers for Disease Control and Prevention. While initial treatment with chemotherapy and radiation can slow the disease, about half of patients eventually qualify for a second line of treatment, Langmuir said.
 
Zactima attacks tumor cells in two ways, combining properties found in Avastin and Tarceva. Like Avastin, it blocks the vascular endothelial growth factor, which creates the blood vessels needed to feed a tumor. Like Tarceva, it attacks cancer cells by interfering with epidermal growth factor receptor, a protein needed to grow and divide.
 
"This study will have immediate clinical implications," said Roy Herbst, lead author of the study and chief of thoracic medical oncology at the University of Texas MD Anderson Cancer Center in Houston. He said more research should be done to determine which patients are most likely to respond to the combined treatment.
 
Zactima failed to reach its goals in two earlier studies. One report hoped to show that Zactima was better than Tarceva when given as a solo treatment in research involving 1,240 patients. The other study, in 534 people, examined whether giving Zactima in addition to Alimta would help prevent cancer from progressing more than Alimta alone.
 
About 85 to 90 percent of lung cancers are of a variety called non small-cell, the type examined in the Zodiac study, according to the American Cancer Society, an advocacy group. The most common side effects with adding Zactima to chemotherapy were rash, diarrhea and hypertension. However, patients experienced less nausea, vomiting, and anemia than with docetaxel alone.
 
Docetaxel is sold as Taxotere by the French drugmaker Sanofi-Aventis.