Pharmion says analyses demonstrate safety, effectiveness of Vidaza in treating blood cancers

By E. Janene Geiss

Philadelphia, Dec. 12 - Pharmion Corp. said Monday that several analyses of data from the Vidaza pivotal phase 3 study demonstrate safety and efficacy in treating patients with Acute Myeloid Leukemia (AML) and myelodysplastic syndromes (MDS).

In a retrospective analysis of efficacy in high-risk MDS patients (RAEB or RAEB-T, age 65 or older), 68 patients were included in the intent-to-treat analysis of the pivotal data, including 31 patients randomized to Vidaza and 37 patients randomized to supportive care. Median overall survival was 19.5 months in the Vidaza arm and 14 months in the supportive care arm, a difference of 5.5 months. Median time to AML transformation with Vidaza was 42.0 months, compared to 17.7 months on supportive care, representing a two-year difference. Median time to the combined endpoint of death or AML transformation was 19.1 months in the Vidaza arm compared to 9.2 months with supportive care, or 9.9 months longer on Vidaza therapy, officials said in a company news release.

In another retrospective analysis of response rates in patients with AML, a total of 105 patients treated with either Vidaza or supportive care demonstrated Vidaza's activity. This analysis was based on three clinical studies in which the French-American-British criteria were originally used. Overall response rates for MDS were 48% complete response and 32% partial response for studies 8421, 8921 and 9221 for Vidaza patients. In study 9221, which was the only study to include a comparator arm, Vidaza patients achieved a median survival of 19.3 months compared to supportive care patients who had a median survival of 12.9 months. In addition, the analysis demonstrated median transfusion independence of 411 days for red blood cells and 363 days for platelets, officials said.

A third retrospective analysis of the phase 3 study, which examined rates of infection and bleeding in all five subtypes of MDS, compared Vidaza plus supportive care versus supportive care alone in patients with MDS.

For this analysis, the Vidaza group included 150 patients, those randomized to the Vidaza arm and patients who crossed over from supportive care to Vidaza treatment as permitted in the pivotal study, officials said.

A total of 147 of the 150 Vidaza-treated patients had pre-existing cytopenias. And the analysis looked at 88 patients considered to be high-risk and age 65 or older.

The Vidaza arm had a 0.64 rate of infection per patient-year of exposure. The supportive care arm had a rate of 0.95 per patient-year. Infections also occurred at a lower rate in the high-risk patient group, 0.38 in the Vidaza arm and 0.76 in the supportive care arm, officials said.

The overall rate of bleeding events was comparable, 0.56 in the Vidaza arm and 0.60 in the supportive care arm.

"We continue to be encouraged by the safety and efficacy data we've seen with Vidaza in the MDS and AML patient populations," Patrick J. Mahaffy, Pharmion's president and chief executive officer, said in the release. "These data are particularly important because patients with MDS, especially those with higher-risk forms of the disease, don't have many treatment options."

The results of these and several other Vidaza studies were presented at the American Society of Hematology annual meeting in Atlanta.

Pharmion is a Boulder, Colo., pharmaceutical company focused on development and commercialization of drugs to treat oncology and hematology.

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