- Study showed no significant difference in overall survival between elacytarabine and investigator’s choice of treatment in AML patients
- Conference call for analysts, investors and press scheduled for tomorrow Tuesday 2 April at 10:00am CET (details below)
Oslo, NORWAY I April 1, 2013 I Clavis Pharma ASA (OSE: CLAVIS), the Norwegian cancer drug development company, announces results of the Phase III CLAVELA study investigating elacytarabine in patients with relapsed or refractory acute myeloid leukaemia (AML). The trial showed that there was no significant difference in overall survival (OS) between the two arms where patients were randomised 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.
All development work with elacytarabine across all indications is now suspended by Clavis Pharma.
Olav Hellebø, Clavis Pharma CEO, said: “The results from CLAVELA are very disappointing for all stakeholders in Clavis and especially for AML patients for whom treatments available at this stage of their disease are few and of limited benefit. I would like to thank the patients, clinicians and all our stakeholders for their support. I would also like to thank the Clavis team for delivering a top quality global clinical trial on time and on budget. We all wish the result would have been different.
“We will review the strategic options for the Company during the coming weeks, and shareholders will be informed about the alternatives available at a later date. Immediate steps will be taken to minimise our expenditure going forward, while caring for those patients who are still benefiting from elacytarabine.”
[CLAVELA is a 380-patient Phase III open-label randomised, controlled trial comparing elacytarabine with the investigator’s choice of treatment in patients with relapsed or refractory AML. Elacytarabine is a novel, patented lipid-conjugated form of the anti-cancer drug cytarabine, which is routinely used in the treatment of AML. The study was conducted at 76 clinical sites in the USA, Canada, Europe and Australia. The primary endpoint of the study is overall survival (OS) and the objective is to demonstrate superiority of elacytarabine over current therapies. Patients were randomised to each arm of the study and the difference in OS and other parameters, including response rates, duration of response, and safety profile of elacytarabine, was measured.]
SOURCE: Clavis Pharma
Post Views: 379
- Study showed no significant difference in overall survival between elacytarabine and investigator’s choice of treatment in AML patients
- Conference call for analysts, investors and press scheduled for tomorrow Tuesday 2 April at 10:00am CET (details below)
Oslo, NORWAY I April 1, 2013 I Clavis Pharma ASA (OSE: CLAVIS), the Norwegian cancer drug development company, announces results of the Phase III CLAVELA study investigating elacytarabine in patients with relapsed or refractory acute myeloid leukaemia (AML). The trial showed that there was no significant difference in overall survival (OS) between the two arms where patients were randomised 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.
All development work with elacytarabine across all indications is now suspended by Clavis Pharma.
Olav Hellebø, Clavis Pharma CEO, said: “The results from CLAVELA are very disappointing for all stakeholders in Clavis and especially for AML patients for whom treatments available at this stage of their disease are few and of limited benefit. I would like to thank the patients, clinicians and all our stakeholders for their support. I would also like to thank the Clavis team for delivering a top quality global clinical trial on time and on budget. We all wish the result would have been different.
“We will review the strategic options for the Company during the coming weeks, and shareholders will be informed about the alternatives available at a later date. Immediate steps will be taken to minimise our expenditure going forward, while caring for those patients who are still benefiting from elacytarabine.”
[CLAVELA is a 380-patient Phase III open-label randomised, controlled trial comparing elacytarabine with the investigator’s choice of treatment in patients with relapsed or refractory AML. Elacytarabine is a novel, patented lipid-conjugated form of the anti-cancer drug cytarabine, which is routinely used in the treatment of AML. The study was conducted at 76 clinical sites in the USA, Canada, Europe and Australia. The primary endpoint of the study is overall survival (OS) and the objective is to demonstrate superiority of elacytarabine over current therapies. Patients were randomised to each arm of the study and the difference in OS and other parameters, including response rates, duration of response, and safety profile of elacytarabine, was measured.]
SOURCE: Clavis Pharma
Post Views: 379
