Richard Doll Seminar - Mylotarg from clinical trial to licensing: A fifteen year odyssey

Robert Hills is Professor of Translational Statistics at the Centre for Trials Research, Cardiff University, and Lead for Clinical Cancer Research Methodology.

His interests include novel trial designs to maximise data from patients in increasingly genetically delineated conditions, and meta-analyses of data from different trials, including a recent individual patient data meta-analysis of gemtuzumab ozogamicin (mylotarg) which has been used to support licensing applications in The United States and the EU.

Since 2006 he has worked in Cardiff as statistician for the NCRI Trials in Acute Myeloid Leukaemia, including introducing the multi-arm multi-stage Pick-A-Winner design for older patients not suitable for intensive chemotherapy, which has so far accumulated data on a dozen comparisons. The NCRI AML trials have also accumulated over 10,000 samples, which has allowed investigations of both prognostic and predictive markers. These results have enabled improved risk stratification and the identification of patients who are not well served by current therapy.

In his talk he will explore the story of Mylotarg, from the first randomised controlled trial (AML15) in 2002 through to the recent approval by the FDA last autumn, including the role of the IPD meta-analysis.