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Bristol-Myers Sprycel Drug More Effective Than Gleevec in Leukemia Study

By Shannon Pettypiece - Jun 5, 2010 Email Share

Bristol-Myers Squibb Co.’s cancer pill Sprycel worked better and faster at eliminating leukemia cells than Novartis AG’s Gleevec, the standard treatment for the blood malignancy, a study of newly diagnosed patients found.

Bristol-Myers said it plans to use the finding to seek expanded U.S. approval for Sprycel as an initial treatment for the form of blood cancer called chronic myelogenous leukemia or CML. Sprycel is already approved as a second-line option for patients who fail to benefit from Gleevec.

The expanded use could more than double sales of Sprycel by 2015 to $900 million, said Tony Butler, an analyst with Barclays. Novartis is also racing to get a next generation leukemia drug, Tasigna, approved as a first-line therapy. Gleevec, Novartis’s second best-selling drug with 2009 sales of $3.9 billion, revolutionized the treatment of CML nine years ago, turning it from a fatal to chronic disease for many patients. Now, the arrival of two new drugs could cut Gleevec’s market share 25 percent in the next five years, Butler said in a report.

“Sprycel could become the next frontline drug for CML and could replace Gleevec,” said Hagop Kantarjian, a leukemia specialist at the University of Texas MD Anderson Cancer Center in Houston, who studied the drug. “For anyone who has a new diagnosis, they should consider this new kind of inhibitor as a viable option that could be better.”

Results from the Sprycel study were released today at the American Society of Clinical Oncology annual meeting in Chicago. Tasigna cut levels of a protein linked to chronic myeloid leukemia in three times as many patients as those taking Gleevec after 18 months, Basel, Novartis reported yesterday in a statement.

Regulatory Decision Due

U.S. regulators are due to make a decision this year on whether to clear Tasigna for newly diagnosed patients, Basel, Switzerland-based Novartis said in April. Like Sprycel, Tasigna already is approved for patients who don’t benefit from Gleevec. New York-based Bristol-Myers plans to seek U.S. regulatory approval this year for Sprycel, the company said in March.

The study released today focused on Sprycel’s ability to attack cells with a defective chromosome in the bone marrow called the Philadelphia chromosome, named after the city where it was discovered. In CML, which affects about 5,000 people a year in the U.S., the Philadelphia chromosome produces a gene called Bcr-AbL, which leads to the overproduction of white blood cells. Gleevec, Sprycel and Tasigna stop this chain of events.

Cell Signal Target

Gleevec was the first drug approved that is designed to suppress a cell signal known to cause cancer rather than poison the tumor cells, as with chemotherapy. Before Gleevec became available, CML patients lived an average of three to five years, according to the American Society of Hematology. With new treatments that have become available over the past decade, 95 percent of CML patients live at least five years.

“Gleevec is a great drug, you will never hear me say anything negative about Gleevec, but in this trial Sprycel did even better,” said Renzo Canetta, Bristol-Myers’s vice president of oncology clinical research. “We think Sprycel can offer something more.”

In the study, 77 percent of patients taking Sprycel had a confirmed complete cytogenetic response, meaning no cells with the Philadelphia chromosome could be found, compared with 66 percent taking Gleevec. An absence of tumor cells is an indicator of longer survival, said Canetta in a telephone interview. The study followed 519 newly diagnosed patients for at least 12 months.

Side Effects

Patients given Sprycel were more likely to have a loss of platelets and fluid build-up in the lungs while patients taking Gleevec were more likely to have fluid retention under the skin. Patients taking Gleevec were also more likely to have nausea, rash and muscle pain.

Doctors will probably need longer-term data on the benefit of Sprycel and Tasigna over Gleevec for 24 to 36 months before they routinely prescribe the newer treatments as a first-line therapy, said Seamus Fernandez, an analyst with Leerink Swann & Co. in a research report.

Price may also keep doctors and patients on Gleevec, said Kantarjian. When generic copies of Gleevec enter the market in 2015 it will cause the price to fall from its average wholesale price of $4,340 for a month’s supply. That price difference could sway some patients to try Gleevec first instead of Sprycel, Kantarjian said. The wholesale price of Sprycel is $6,950 at the 100-milligram dose, Bristol-Myers said.

Gleevec Still ‘Reassuring’

“I don’t think this is going to be the end of Gleevec,” Kantarjian said in a telephone interview. “The long-term follow up with Gleevec is very reassuring. Gleevec will also become generic in four to five years so the price difference could become significant.”

Bristol-Myers also reported data today that showed its experimental skin cancer drug ipilimumab almost doubled the number of patients alive after two years compared with another experimental treatment called gp100, developed by the National Cancer Institute. Bristol-Myers said it hopes to start selling the medicine by the end of 2012. If approved, ipilimumab could generate more than $1 billion in annual sales, analysts said.

To contact the reporter responsible for this story: Shannon Pettypiece at [e-mail].