Date: 2013-04-01
Type of information:
phase: 3
Announcement: results
Company: Clavis Pharma (Norway)
Product: elacytarabine
Action mechanism: Elacytarabine is a novel, patented lipid-conjugated form of the anti-cancer drug cytarabine created by Clavis Pharma using its Lipid Vector Technology (LVT).
Disease: late-stage acute myeloid leukaemia
Therapeutic area: Cancer - Oncology
Country: USA, Canada, Europe and Australia
Trial details: The CLAVELA study 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. The study is being 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 have been 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, will be measured.
Latest
news: * On May 14, 2013, Clavis Pharma, a Norwegian cancer drug development company, has announced that Olav Hellebø will leave the position as CEO of the company effective 20 May by mutual agreement. This is a consequence of the significant down scaling of the Company's operations following the negative outcome of the CLAVELA phase III study in April.
* On April 1, 2013, Clavis Pharma, a Norwegian cancer drug development company, has announced 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. Clavis Pharma will now review its strategic options.
* On December 6, 2012, Clavis Pharma has announced that it has reached the enrolment target for its Phase III CLAVELA study investigating elacytarabine in patients with relapsed or refractory acute myeloid leukaemia (AML). Top-line data are expected to be available in Q1 2013.
* On August 25, 2011, Clavis Pharma has announced that the company has decided to expand its pivotal Phase III CLAVELA study, investigating elacytarabine in patients with late-stage acute myeloid leukaemia (AML), in order to maximise the chances of success, the statistical power of the study has been increased from 80% to close to 90%. The inclusion criteria have also been amended, and patients over the age of 65 with disease of poor prognosis are now eligible for study entry after only one previous treatment cycle, significantly expanding the potential first launch patient population.
The primary endpoint of survival will now be evaluated after 300 events have occurred vs. 250 events previously, and the study is expected to enrol approximately 400 patients. Top line data are now expected to be available in Q4 2012.
