ASH 2024 | The potential of daratumumab in HR-SMM: single agent and Dara-VRd

So I think this year is such an important year for smoldering myeloma. We have the Phase III trial of daratumumab versus observation being presented, and hopefully that will be a game changer. It will be for the first time we show, not really for the first time, but a sponsored study that potentially may lead to FDA registration of daratumumab single agent versus observation, showing a huge difference in progression-free survival and a trend of overall survival. And if you build on that, we know that we don’t use right now daratumumab as a single agent in multiple myeloma, but we use a four drug regimen. So we already have the data of Dara-RVd, which is the standard of care of newly diagnosed myeloma. Can we bring it earlier into the high-risk smoldering myeloma setting? And the answer is absolutely yes. We’re seeing impressive deep remissions, MRD-negative disease. And we show that you can treat those patients for two years. And the nice thing is if they are still MRD positive, then we give them two more years of maintenance. So it’s risk adapted. So already we’re trying to anticipate that if you are MRD positive, can we improve on it and deepen the response by giving you two more years. But the patients who are MRD negative, we’re leaving them. And it hopefully will make a big difference that you can treat with their RVd. You can get that deep remission and you can make a difference in smoldering myeloma.

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