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18 December 2023

BelaCarD @ ASH 2023 - preliminary results from planned interim analysis poster presentation

Following the full recruitment of 70 patients to BelaCarD, we conducted a per-protocol interim analysis, looking at the proportion of patients who achieved PR or better in the first two cycles of treatment with belantamab mafodotin (belamaf), carfilzomib (K) and dexamethasone (d) . This equates to one dose of belamaf. We also analysed the safety data available at the time of analysis. The preliminary safety and efficacy results of this analysis were presented by Dr. Masa Lasica and Prof. Hang Quach at ASH 2023. Overall:

  • Belamaf-Kd with an extended belamaf schedule (2.5mg every 8 weeks) demonstrates a manageable safety profile with no unexpected toxicities
  • Consistent with previous reports, blurred vision and thrombocytopenia were the most prevalent AEs reported in cycle 1 but majority were mild.
  • Although keratopathy was prevalent, vast majority of patients had complete recovery to their baseline corneal architecture.
  • The preliminary efficacy data on the BelaMaf-Kd combination therapy with extended BelaMaf schedule is encouraging with deep responses observed after only 2 cycles of therapy

For more information about the poster and preliminary results, please contact AMaRC (amarc@alfred.org.au) or Prof. Hang Quach (Hang.Quach@svha.org.au)

With recruitment now completed, the main analysis of the primary endpoint (progression free survival) will be conducted once all patients on study have completed their 12-month assessment. We expect this to occur in Q3 2024.