DREAMM-7 Trial Update (BelaVd vs DaraVd) in RRMM | Maria Victoria Mateos, MD | EHA 2024

Hello to everyone. My name is Maria Victoria Mateos. I work as a hematologist at the University Hospital of Salamanca in Spain, and we are here attending EHA 2024 in Madrid. And I will present on behalf of all co-investigators of the DREAM 7 clinical study the results of a Phase III randomized clinical study conducted in relapsed refractory myeloma patients after at least one prior line of therapy in which Belantamav, in combination with Bordesomibandexamedazone, has been compared with Daratumumab in combination with Bordesomibandexamedazone. As you know, Belantamav is the first BCMA antibody drug conjugated with monometilauristatin F. And in this study, 494 patients were included. All patients had to receive at least one prior line of therapy. The median number of prior lines was one. And of note, 52% of the patients were exposed to lenalidomide, and approximately one-third of them were indeed refractory to lenalidomide. The primary endpoint of this study was progression free survival, and the trial met its primary Bella-VD resulted into a significantly and clinically meaningful longer progression free survival in comparison with the DaravD. The median PFS was 36.6 months versus 13.4 months, with a hazard ratio of 0.41. And what is also important is to remark that the superiority for Bella-VD was sustained across the different group of patients, including challenging populations, those patients refractory to lenalidomide, or those patients with high-risk cytogenetic abnormalities. The superiority for Bella-VD was also observed in terms of overall response rate, complete response rate or better, and it was basically the double, 34% for Bella-VD versus 17 for DaravD. But also we know that in myeloma, minimal residual disease negativity is maybe the most powerful prognostic marker. And Bella-VD resulted also in approximately 25% of MRD negativity rate, clearly superior to no more than 9% observed with DaravD. Although the follow-up is not very long at the present time, approximately 28 months, we see already a clear trend to benefit in terms of overall survival, what it is also relevant with a hazard ratio of 0.57. Durability of the response is also longer for Bella-VD. And in terms of safety profile, Bella-VD resulted numerically in higher incidence of adverse events. From the hematological point of view, thrombocytopenia is the most frequent one, and from the non-hematological point of view, we have to concentrate on the ocular events. And when we evaluate the best corrected visual equity, it's true that approximately 34% of the patients experience a worsening in the visual equity from normal visual equity with blurred vision. But only five patients reported an impaired vision with a best corrected visual equity of 2200. And in addition, and I think that this is very important indeed for patients, with those delays and those modifications, all patients basically resolved the keratopathy. And what we've seen in the Dream 7 is at the beginning, Bella-Maff was delivered every three weeks. But over treatment, the majority of the patients had to increase the time between two administrations. Until 10 or 12 weeks. This factor didn't impact in the efficacy, but resulted in a significantly lower incidence of ocular events and into a significant reduction of the number of patients who had to discontinue Bella-Maff. So, overall, I think that all these data clearly supported the role of Bella-Maff, Bortezumip, and Dexamedazone as a new potential combination for relapsed refractory myeloma patients after one prior line of therapy. And with this new combination, we are going definitely to increase the number of possibilities for our myeloma patients after just one prior line of therapy. And we know how the BCMA targeted therapy are rapidly moving to the first line of therapy. Filtafel is already approved. Biospecific monoclonal antibodies are coming. And we are going to have now also Bella-Maff in combination with VD, maybe based on the Dream 8 also Bella-Maff in combination with PD. And from my personal point of view, I think that this will allow us to deliver a much more personalized therapy for each patient based on their characteristics, based on this lifestyle and based on the risk status as well as comorbidities. Thank you very much.