IMS 2025 | Updated findings from GEM2017FIT: triplet versus quadruplet regimen in NDMM

The GEM2017FIT Phase III trial was devoted to analyze the efficacy of a triplet versus a quadruplet, KRd versus Dara-KRd, and we also used a knowledge standard of care that was developed also by the Spanish myeloma group by combining cycles of VMP plus lenalidomide and dexamethasone. In total, patients receive 18 cycles of induction. Should be mentioned that in those patients that were not exposed to daratumumab up front, what we did is to give them the opportunity to receive four consolidation cycles. This applies to the KRd arm and also the VMP-Rd arm. In other words, at the end of the day, we were trying to explore if not using dara upfront due to economical constraints in some countries may be compensated by the addition of daratumumab plus lenalidomide and dexamethasone as part of the consolidation before moving into the maintenance. Okay, what we have seen is that the consolidation, after induction, the MRD rate was slightly superior for Dara-KRd, 61% versus 54% for KRd, and it was much lower for VMP-Rd, was just 27%. But in the setting of the consolidation, what we have seen is that adding the four cycles of consolidation, if you look to the 10 to the minus 5 MRD rate, does not increase so much in the KRd arm because it moved from 54 to 56%. It moved from 27 to 40% in the weakest induction, VMP-Rd. If you concentrate into the 10 to the minus 6, the evidence is more clear for the consolidation in the KRd arm because it increased from 47 to 54%. In terms of progression-free survival, we have not seen so far any difference with a follow-up of almost four years, any difference in the progression-free survival between KRd and Dara-KRd. at 50 months, it was 67% and 71%. Much lower, the PFS for the patients that receive VMP are the old regime in the induction, because at 50 months, it was just 52%. But probably what is very, very interesting in this study is that in spite there were fit patients, we have used a more sophisticated scale to assess the fitness of the patients. It’s the GAH scale. The lower the GAH score, the better the status of the patient. Okay? And what we have seen is that in patients that were really fit, In those that have a GAH less than 20, I mentioned that the lower the scale, the better the status. In those that have GAH scale less than 20, there were no significant difference between Dara-KRd and KRd. In fact, slightly better Dara-KRd, 50 months 72% versus 69%, inferior for VMP Rd. But if you move to the patients that all the way fit, they have through the scale not so fit status, the scale was over 20. In that setting, the patients receiving KRd did better with a PFS of 73% of 50 months as compared to 67% for patients receiving Dara-KRd. In other words, I think this story is helping us to grade the intensity of the treatment according to the fitness. And I think this is the second message.

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