Hi, I'm Ola Langren. I'm a professor of medicine and I lead a myeloma program at the University of Miami in beautiful Miami, Florida. I'm here at IHA 2025 in Milan, Italy to present the ADVANCE clinical trial. This is a large, randomized, multi-center study for newly diagnosed patients with multiple myeloma. The primary endpoint of the study is to determine MRD negativity after eight cycles of combination therapy. The study shows that the daratumumab added to KOD increases the MRD negativity rate significantly. About 60% of the patients are MRD negative with a combination of daratumumab, corfulsimilblenalidomide and dexamethasone. This is highly significant. The p-value is less than 0.0001 and the adjusted odds ratio is 2.9. Also, I do present here at the meeting multiple results as part of the planned secondary endpoints, including stratifications for MRD negativity by age and the midpoint of age in the study is around 60 years. So looking above and below 60 years, the daratumumab KOD regimen is significantly better independent if you're above or below the threshold for 60 years. Also, we stratified by high risk and standard risk and we see that the delta in terms of improvement with the addition of daratumumab is over 20% in the patient with high risk disease, supporting the idea that using a better therapy for patients in high risk disease is really very important. But also, importantly, patients with standard risk disease, they have actually the best outcome with the daratumumab added to KOD backbone. The delta is over 30%. So I think this is another study indicating that do not follow the idea of risk adaptive therapy. Instead, give the best therapy to every patient and the best therapy is needed for patients with high risk disease, but the best therapy will always work the best in patients with standard risk disease. Also, other secondary endpoints of this study include progression-free survival. The median follow-up time is 31.2 months. So around three years out from randomization, we see that 92% of the patients remain free from progressive disease on the darakod arm. So that's a very strong result. And lastly, as for results, I was very proud to show that we enrolled all the 306 patients at only seven dedicated centers, independent academic centers in the United States. I should also say that as for the safety, there is no new safety concern. There are similar results for safety as you see for the individual drugs. It's very well balanced between the two arms and there is also no new serious adverse event signal, very similar to what I mentioned. The signal is similar to what you have seen for the individual drugs and is very well balanced. So the study delivered its primary endpoints. MOD negativity is significantly better with darakod over KOD. And as I mentioned, at three years of follow-up, 92% of patients remain free from progression on darakod. So we conclude that darakod should be a new standard of care for patients with multiple myeloma and this is independent of transplant eligibility.
HealthTree • June 26, 2025