Novartis: Gleevec study in myeloid leukemia patients shows 90.3% survival rate

By Angela McDaniels

Seattle, Dec. 12 - Novartis Pharmaceuticals Corp. said 90.3% of patients with Philadelphia chromosome-positive chronic myeloid leukemia who are taking Gleevec (imatinib mesylate) tablets in a phase 3 clinical trial are still alive after 54 months of treatment.

Moreover, the yearly risk of progressing to advanced disease fell to less than 1% in the fourth year, the lowest rate seen in the study so far.

The results also showed that 100% of patients who achieved a major molecular response to treatment at 12 months - meaning that their disease was at extremely low levels - were free of progression to accelerated phase or blast crisis at 54 months, the company said.

"After collecting nearly five years of data in this trial and also considering 178,000 patient years of clinical use, we see that the longer chronic myeloid leukemia patients continue to take Gleevec the lower their yearly risk of progressing to accelerated phase or blast crisis," said David Epstein, president of Novartis Oncology, in a company news release.

"These results are remarkable because they have been reported in patients taking the recommended starting dose of 400 mg per day. In addition, data from several international studies ... show that investigational daily doses of Gleevec as high as 800 mg can produce even higher rates of molecular response."

The study, with 1,106 patients, is the largest clinical trial to date for newly diagnosed adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia in chronic phase, the company said. It was held in 177 centers in 16 countries.

One group of patients received 400 milligrams per day of Gleevec and another received interferon 5 MIU M2 per day with cytarabine 20 mg/M2/day for 10 days each month.

Estimated responses to first-line drug treatment with Gleevec at 54 months were 98%, 92% and 86% for complete hematologic responses, major cytogenetic responses and complete cytogenetic responses respectively, the company said. Gleevec continued to be generally well tolerated as first-line drug therapy for Ph+ chronic myeloid leukemia at the 54-month follow-up.

New data from a retrospective comparative analysis based partially on the phase 3 trial showed for the first time that Gleevec significantly extended overall survival in newly diagnosed Ph+ chronic myeloid leukemia patients compared with the historical treatment of interferon plus cytarabine, the company said.

Investigators at the University Hospital in Poitiers, France, undertook this retrospective historical analysis because a large number of patients in the phase 3 study who received interferon plus cytarabine were switched to Gleevec early in the study, making it difficult to perform an adequate long-term prospective comparative analysis.

At 36 months, the overall survival rate for patients receiving Gleevec as a first-line treatment was 92% compared to 84% for patients receiving first-line interferon plus cytarabine. This overall survival benefit was highly statistically significant, the company said.

Results from both studies were presented Monday at the 47th Annual Meeting of the American Society of Hematology in Atlanta.

Gleevec tablets are indicated for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia in chronic phase patients with Ph+ chromic myeloid leukemia in blast crisis, in accelerated phase, or in chronic phase after failure of interferon-alpha therapy. The drug is known as Glivec (imatinib) outside the United States.

Novartis Pharmaceuticals is based in East Hanover, N.J., and researches, develops, manufactures and markets prescription drugs used to treat a number of diseases and conditions. It is an affiliate of Novartis AG, based in Basel, Switzerland.

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