At # ASH23 , Omar Nadeem, MD, Dana-Farber, presented findings from the phase 2 clinical trial, Immuno-PRISM. Results suggest early use of immunotherapy may have even greater benefit for people with high-risk smoldering myeloma.
The context of this study is that we have patients that have precursor uh conditions to multiple myeloma. Uh one called smoldering myeloma, in which there is a category of high risk patients that have a very high probability of developing multiple myeloma in the next two years, multi myeloma can cause debilitating uh organ damage and symptoms. So, the goal for these patients is to prevent that. And so far there isn't clear uh guidance or consensus about what the best therapy for these patients is that are asymptomatic but have high risk of aggression. So, our hypothesis was that uh immunotherapy may be the best solution here because the patient's immune system at this stage in their life or the course of their journey with this disease is much healthier than it is in patients that have relapse myeloma where currently immunotherapy agents such as by specific antibodies are approved. Uh So this is a platform study looking at the comparison of TLI which is ABC MA by specific antibody against the control arm of lenalidomide and dexamethasone. These are two agents that have proven in the past to show benefit in patients with high risk smoldering myeloma 19 patients were enrolled into the study of which we have data to report for 12 patients that receive Tiam. What was really striking about this study was the uh efficacy results. So 100% of patients achieved the response to therapy and 83% of those patients actually achieved a complete response to therapy with um uh resolution of their uh their disease. And when we dug deeper, looking at minimal residual disease or MRD in their bone marrow, we saw that 100% of patients were negative for MRD, both at the 10 to the minus five level and an even deeper 10 to the minus six level. These numbers are are fourfold greater really. Uh when you look at the 10 to the minus six level compared to what we see with this exact uh drug in patients with relapse myeloma. And we also saw that these responses so far are durable and nobody has progressed. Yes on the um yet on therapy. So, so far, in conclusion, Tiam and high risk VM myoma patients uh demonstrated an overall response rate of 100%. Uh with 100% of patients achieving MRD negativity, the safety profile so far appears uh improved compared to relapse myeloma with fewer grade three infections uh and um cytokine release syndrome. And so far, we are um moving on with enrollment to the randomized portion of this study and additional arms to be added. And I think this is a proof of concept study that demonstrate that um if you give immunotherapy early to these patients, uh you will see even better efficacy results and hopefully prevention of multiple myeloma in their lifetime.
