Clavis Pharma stops elacytarabine development on negative Ph III trial in acute myeloid leukemia

2 April 2013

Shares of Norwegian cancer drug developer Clavis Pharma (OSE: CLAVIS) plunged 83.8% to 1.10 Norwegian kroner this morning (April 2), as markets reopened to the news that results of the Phase III CLAVELA study investigating elacytarabine in patients with relapsed or refractory acute myeloid leukemia (AML) showed that there was no significant difference in overall survival (OS) between the two arms where patients were randomized to receive either elacytarabine or investigator’s choice of treatment.

Median survival in the elacytarabine arm was 3.5 months, compared to 3.3 months in the control arm, with a hazard ratio of 0.97. Adverse events were comparable between the two arms, and no meaningful differences were observed in any subgroup analyses. As a result, the company said on Monday (April 1) that all development work with elacytarabine across all indications is now suspended by Clavis Pharma.

Second major disappointment for Clavis

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