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LOS ANGELES, Dec 2, 2000 (Reuters) — Nearly 30 percent of patients with a common form of leukemia have no traces of the disease after being treated with an experimental pill made by Novartis AG , researchers said on Saturday.
The Swiss pharmaceutical giant released updated results from a 532-patient Phase II trial of STI571, which has been given the brand name Glivec, at a meeting Saturday of the American Society of Hematology in San Francisco.
"Last year we reported that patients in the trial had their blood counts return to normal. This year we are reporting, with a much larger patient population, that nearly 30 percent have no detectable leukemia," said Dr. Brian Druker, a study investigator based at Oregon Health Sciences University.
The once-daily oral drug works by inhibiting a critical protein that causes chronic myelogenous leukemia (CML), a deadly disease that affects up to 23,000 people in the United States at any given time.
"Glivec is one of a new class of anti-cancer drugs that selectively target genetic defects without causing the severe side effects associated with existing chemotherapy."
CML is caused by a chromosome defect in blood cells that creates an abnormal version of an enzyme that causes white blood cells to proliferate uncontrollably.
Researchers suggested that once Glivec starts being used in newly-diagnosed patients it may have the potential of eliminating the disease for long periods, or even permanently.
Novartis has said it expects the drug to become a first-line therapy, used as an alternative to painful bone marrow transplants and alpha-interferon, a more toxic, injectable treatment.
The open-label study, led by researchers at the Anderson Cancer Center in Houston, Texas involves patients in the earliest stage of the disease who failed treatment with interferon alpha regimens, a common treatment for patients who cannot undergo bone marrow transplants.
New Class of Anti-cancer DrugsAt three months, preliminary results from 388 patients found that 37 percent of patients reaching so-called cytogenetic remission — a significant drop in the number of white blood cells carrying the genetic mutation that causes the disease, including 13 percent who saw those levels drop to zero. The six-month results for 290 patients suggest an overall response rate — both partial and complete — of 56 percent, Novartis said. Glivec is one of a new class of anti-cancer drugs that selectively target genetic defects without causing the severe side effects associated with existing chemotherapy. Researchers said the most common side effect of the new drug is nausea. CML progresses over several years from the the chronic stage, which typically lasts three to four years, to an accelerated phase and eventually to the generally lethal ``blast crisis'' stage. In a trial of patients with CML in the accelerated phase, four weeks of preliminary data from 154 patients showed an overall blood cell count response rate of 78 percent, with 14 percent achieving complete remission, Novartis said. A third Phase II study of the drug in patients with CML in the "blast crisis" stage, preliminary data showed a response rate of nearly 50 percent in those who had not received prior treatment and 33-38 percent in patients who had received other therapy. "The median survival has been eight to 10 months, compared with a usual three months for these patients," said Dr. Charles Sawyers, professor of medicine at the University of California at Los Angeles, the lead center for the "blast crisis" trial. He said 30 percent of the patients with this advanced stage of the disease are still alive after being treated in the trial that began just over a year ago. Novartis is expected to submit clinical data on Glivec in marketing applications to regulators in Europe and the United States during the first quarter of next year.
Source: Reuters
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