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ASH 2024 | Results of IFM2017-03: dexamethasone-sparing regimen in frail patients with newly diagnosed myeloma
Salomon Manier, MD, PhD, Lille Hospital University, Lille, France, presents the results of the Phase III IFM2017-03 trial (NCT03993912) comparing a dexamethasone-sparing regimen with daratumumab and lenalidomide to lenalidomide-dexamethasone (len-dex) for frail patients with newly diagnosed multiple myeloma (MM). Dr Manier highlights that this regimen significantly improved progression-free survival (PFS) and overall survival (OS) compared to the standard len-dex regimen while demonstrating a comparable safety profile regarding non-hematological side effects, infection rates, and treatment discontinuation. This interview took place at the 66th ASH Annual Meeting and Exposition, held in San Diego, CA.
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Transcript (AI-generated)
So we’ve been presenting this IFM 2017-03 trial. It’s a Phase III trial. We can say that it’s the first Phase III trial dedicated to elderly frail patients with newly diagnosed multiple myeloma. So the rationale is that those patients, we know from the MAIA study for example, that they have more adverse events and infections and more treatment discontinuation when you treat them with DRd versus Len-Dex...
So we’ve been presenting this IFM 2017-03 trial. It’s a Phase III trial. We can say that it’s the first Phase III trial dedicated to elderly frail patients with newly diagnosed multiple myeloma. So the rationale is that those patients, we know from the MAIA study for example, that they have more adverse events and infections and more treatment discontinuation when you treat them with DRd versus Len-Dex. So we came up with the idea to explore a dexamethasone-sparing regimen with daratumumab and lenalidomide and just two cycles of dexamethasone and then the patient would stop dexamethasone. And we compared this to the previous standard of treatment, the Len-Dex, until progression.
So 295 patients were randomized in a 2:1 manner, 200 in the DR arm and 95 in the Len-Dex arm. The population is frail, so median age is 81 years old, and the patients have an IFM frailty score of two or more. So we reported the primary endpoint, which is the PFS. The median PFS is 53 months in the DR group as compared to 22.5 months in the Len-Dex group, control group. Hazard ratio is 0.51 and it’s a significant p-value. We also observe a difference in overall survival. The median overall survival is not reached for the patients treated with DR and it’s 47 months in the patients treated with Len-Dex and it’s significant again. Hazard ratio at 0.52.
And in terms of safety, we see that the patients treated with daratumumab and lenalidomide don’t have more non-hematological side effects. So it’s a similar number compared to Len-Dex. And especially for infection, it’s 19% of grade 3/4 infections in patients treated with DR and 21% in patients with Len-Dex. And similar for pneumonia specifically, 6% with daratumumab lenalidomide and 8% with Len-Dex. And no more treatment discontinuation with daratumumab lenalidomide versus Len-Dex, 30% versus 34%. So it’s very encouraging data. And we think that treating the patients, elderly patients with frail status with this dexamethasone-sparing regimen is probably the next standard of care treatment.
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Disclosures
Takeda: Consultancy; Sanofi: Consultancy; Novartis: Consultancy; Janssen: Consultancy; GlaxoSmithKline: Consultancy; Celgene/BMS: Consultancy; Amgen: Consultancy; Adaptive Biotechnology: Consultancy; Roche: Consultancy; Regeneron: Consultancy; Abbvie: Consultancy.
