Servier has reported positive top-line data from the Phase III AGILE clinical trial of Tibsovo (ivosidenib tablets) in adult patients with treatment naïve IDH1-mutated acute myeloid leukaemia (AML).

When given in combination with the chemotherapy azacitidine, the drug led to a statistically significant improvement in event-free survival (EFS) compared with azacitidine plus placebo, meeting the primary endpoint.

EFS was determined as the time from randomisation until failure of therapy, relapse from remission or death due to any cause, whichever event takes place first.

AGILE is a multi-centre, double-blind, randomised, placebo-controlled trial designed to assess the safety and efficacy of the treatment in newly diagnosed patients who were not eligible to receive intensive chemotherapy.

The trial also met all the major secondary goals such as complete remission (CR) rate, overall survival, CR and complete remission with partial hematologic recovery rate, and objective response rate.

Tibsovo is the first targeted treatment to improve event-free survival, as well as overall survival when given with azacitidine compared with azacitidine alone, Servier said.

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The safety profile of Tibsovo plus azacitidine in the Phase III trial was similar to previous data.

AGILE stopped further enrolment according to the Independent Data Monitoring Committee (IDMC)’s recommendation since a clinically meaningful difference was noted between the treatment arms.

Servier Pharmaceuticals clinical development vice-president Susan Pandya said: “Tibsovo monotherapy has been instrumental in transforming outcomes for adult patients with newly diagnosed or relapsed refractory AML harbouring an IDH1 mutation.

“These promising results from the AGILE study support the added benefit of inhibiting the mutant IDH1 enzyme in combination with standard chemotherapy in the newly diagnosed intensive chemotherapy ineligible setting.”

Tibsovo holds approval in the US as monotherapy to treat IDH1-mutant relapsed or refractory AML in adults.

The drug is also indicated for the treatment of newly diagnosed IDH1-mutant AML in people aged 75 years and above or those with comorbidities that prevent the use of intensive induction chemotherapy.

Last month, Servier partnered with Oracle to modernise and standardise its clinical trials approach.