In the primary endpoint analysis, Vidaza treatment was associated with a median survival of 24.4 months versus 15 months for those receiving conventional care regimens (CCR), an improvement of 9.4 months. Two-year survival rates were 50.8% versus 26.2% for patients receiving Vidaza versus CCR.
The survival benefits of Vidaza were consistent regardless of the CCR treatment option – best supportive care (BSC) alone, low-dose cytarabine plus BSC or standard chemotherapy plus BSC – utilized in the control arm.
“We are extremely gratified with the results from the Vidaza Survival Study, which for the first time bring the hope of prolonged survival for patients with higher-risk MDS,” said Patrick Mahaffy, Pharmion’s CEO and president. “As the only therapy to have ever demonstrated a survival advantage in MDS, and especially to have demonstrated an improvement of this magnitude, Vidaza is unique in the treatment for this disease.”
Pharmion expects to present full study results at an upcoming medical meeting. Based on these results, Pharmion intends to file a marketing authorization application in the European Union for Vidaza for the treatment of higher-risk MDS before the end of this year. The company will also file a supplemental new drug application with the FDA to include these data in the prescribing information in the US.