Daihe: AKESO (09926) HARMONi-2 mid-term OS analysis met expectations, slightly boosting confidence in global first-line NSCLC phase III trial OS success.

Daiwa published a research report stating that AKESO (09926) has achieved the key secondary endpoint of overall survival (OS) in the phase III study of Ivosidenib as a first-line treatment for PD-L1 expressing positive NSCLC, as per the pre-specified interim analysis evaluated by an independent data monitoring committee. The firm maintains a Buy rating on AKESO. Daiwa believes this result further validates the clinical benefit of Ivosidenib in terms of OS for first-line NSCLC treatment, successfully translating strong progression-free survival (PFS) clinical benefits. The firm pointed out that the previously announced median PFS was 11.14 months for the Ivosidenib group and 5.82 months for the control group receiving Pembrolizumab, with a PFS hazard ratio (HR) of 0.51 (P<0.0001). The company had previously also reported an early interim OS HR of 0.777. Although detailed data from this interim OS analysis has not yet been published, Daiwa believes that this result helps to slightly increase confidence in the success of its global phase III trial for OS in first-line NSCLC.