Sparks - Mendus

Mendus has announced that the first patient has been enrolled in the Phase II AMLM22-CADENCE trial, sponsored by the Australasian Leukaemia and Lymphoma Group. The trial is a multicentre, randomised controlled study testing vididencel in combination with the standard-of-care oral azacitidine versus oral azacitidine alone as a potential maintenance treatment for acute myeloid leukemia (AML). The CADENCE trial, which includes both measurable residual disease (MRD+) and MRD- patients will be conducted in two parts. The first will assess safety in 40 patients and the second will assess efficacy in 100 patients. Mendus aims to potentially use the safety data to support its dossier for its internal Phase III registrational study, which we expect to commence in 2026.

We note that the initiation of first patient recruitment was slightly slower than expected, although management has stated that its plans for the registration study are not entirely tied to the safety data from the CADENCE trial and remain on track to be pivot-stage ready by H225.