ASH 2023 | Preliminary results of GEM2017FIT: comparing induction therapies in fit elderly patients with MM
Maria Victoria Mateos, MD, PhD, University of Salamanca, Salamanca, Spain, presents the preliminary findings of the Phase III GEM2017FIT trial (NCT03742297) comparing three induction regimens in transplant-ineligible fit, elderly patients with newly diagnosed multiple myeloma (MM). The standard of care (SoC) arm of bortezomib-melphalan and prednisone (VMP) followed by lenalidomide and dexamethasone (Rd) was compared to 18 induction cycles of carfilzomib plus lenalidomide and dexamethasone (KRd) with or without daratumumab (Dara). Measurable residual disease (MRD) negativity was significantly higher in the KRd and Dara-KRd arms after the 18 induction cycles. Although assessment of consolidation and maintenance outcomes is still ongoing, there also appears to be an improvement in progression-free survival (PFS) in these cohorts. Dr Mateos highlights that hematological scores and geriatric assessments may be valuable tools for predicting toxicity and mortality in these older patients to ensure the best treatment decisions are made. This interview took place at the 65th ASH Annual Meeting and Exposition, held in San Diego, CA.
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Transcript (edited for clarity)
This is a Phase III clinical study conducted by the Spanish Myeloma Group in a transplant-ineligible population between 65 and 80 but fit, according to a geriatric assessment and hematology score. And in this Phase III randomized trial, we compared three induction regimens: VMP followed by len/dex -this was our standard of care, and the experimental arms were carfilzomib, lenalidomide, and dexamethasone; daratumumab, carfilzomib, lenalidomide and dexamethasone, 18 cycles...
This is a Phase III clinical study conducted by the Spanish Myeloma Group in a transplant-ineligible population between 65 and 80 but fit, according to a geriatric assessment and hematology score. And in this Phase III randomized trial, we compared three induction regimens: VMP followed by len/dex -this was our standard of care, and the experimental arms were carfilzomib, lenalidomide, and dexamethasone; daratumumab, carfilzomib, lenalidomide and dexamethasone, 18 cycles. Following induction, patients are receiving consolidation as well as maintenance, but the presentation here at ASH was focused on the 18 induction cycles, and the primary endpoint was the minimal residual disease negativity rate after 18 induction cycles. And we had the opportunity to see how KRd as well as daraKRd, resulted in a significantly higher MRD negativity rate in comparison with VMP len/dex. And in principle, although the median follow-up is 33 months and we have to wait in order to see the role of consolidation and maintenance in terms of progression-free survival, KRd and daraKRd seem to be also superior to VMP ln/dex.
But I would also like to add something about the fitness and the geriatric assessment and hematology score, because this scale is able to predict the toxicity as well as mortality. And we’ve seen that, for example, patients eligible for daraKRd, patients in which we have observed the better outcomes, are those patients with a geriatric assessment and hematology score lower than 20. However, patients with a geriatric assessment and hematology score higher than 20, this means that these patients are less fit, maybe they can obtain a benefit just with carfilzomib, lenalidomide, and dexamethasone in order to avoid early mortality rate. But these are just preliminary data based on the primary endpoint, and new data will be coming when we evaluate the consolidation as well as maintenance.
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Disclosures
Honoraria: BMS-Celgene, Janssen, Abbvie, GSK, Amgen, Takeda, Oncopeptides, Sanofi, Pfizer, Regeneron, Stemline; Membership on an entity’s Board of Directors or advisory committees: BMS-Celgene, Janssen, Abbvie, GSK, Oncopeptides, Sanofi, Pfizer, Stemline; Current Employment: University of Salamanca/Gerencia Regional de Salud de Castilla y León.
