I will present during this ASH congress the results of the first phase III randomised trial in which the monoclonal antibody daratumumab has been evaluated in newly diagnosed myeloma patients. The ALCYONE trial is a phase III randomised trial in which 706 newly diagnosed myeloma patients and not candidates for autologous stem cell transplantation were included and randomised one to one to receive bortezomib, melphalan and prednisone for nine cycles, the standard of care, versus bortezomib, melphalan and prednisone plus daratumumab. Beyond cycle number nine the control arm stopped treatment whilst the experimental arm continued receiving daratumumab as a single agent until disease progression. The primary endpoint of the trial was progression free survival and the median follow-up is 16.5 months but the addition of daratumumab to bortezomib melphalan and prednisone resulted in a significant prolongation in the progression free survival. In fact, the median has not been reached whilst it was 18.1 months for the control arm. The hazard ratio is 0.5 which means that if we add daratumumab to the standard of care, VMP, we are going to reduce the probability of progression or death by 50%. This benefit in progression free survival is derived from the secondary endpoint, overall response rate, and especially complete response rate because 91% of the patients achieved at least a partial response in the experimental arm and the proportion of patients who achieved a complete response was 43%, approximately double in comparison with the control arm in which the complete response rate was 23%. In addition, the minimal residual disease was also evaluated inside the bone marrow and 22% of the patients achieved MRD negative in the experimental arm versus 7% in the control arm. The addition of daratumumab to VMP did not result in more adverse events or serious adverse events from the haematological point of view and from the non-haematological point of view infections and pneumonia were observed more frequently in the experimental arm but most resolved and only one patient needed to discontinue the study due to these adverse events.

So, in summary, I think that all these results confirm or support the addition of daratumumab to the standard of care, VMP. Finally, daratumumab plus VMP is a new standard of care for this patient population – elderly patients with newly diagnosed myeloma patients or non-transplant eligible newly diagnosed myeloma patients.