Shares of Sunesis Pharmaceuticals, Inc (SNSS) plunged significantly after the company announced that its phase III trial, VALOR, failed to meet its primary endpoint. The randomized, double-blind, placebo-controlled trial (n=711) evaluated the efficacy of Qinprezo (vosaroxin) and cytarabine in patients suffering from first relapsed or refractory acute myeloid leukemia (AML).

The trial failed to reach its primary endpoint of a statistically significant improvement in overall survival. The combination demonstrated a median overall survival of 7.5 months for Qinprezo and cytarabine compared to 6.1 months for placebo and cytarabine.

However, the trial demonstrated a clinically important improvement in the complete remission rate (30.1% versus 16.3%), thereby meeting the secondary endpoint.

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Consequently, Sunesis now plans to initiate a marketing authorization application with the European Medicines Agency. The company also plans to meet with the FDA to determine an appropriate regulatory path.

We note that Qinprezo enjoys orphan drug designation in both the U.S. and EU for the treatment of AML. Moreover, the FDA has granted fast track designation to Qinprezo for the potential treatment of relapsed or refractory AML in combination with cytarabine.

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Sunesis does not have any approved drug in its portfolio. Hence, the failure of the trial came as a disappointment as Qinprezo is Sunesis’ lead product candidate. We expect investor focus to remain on further updates from Sunesis’ development plan.

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