My name is Professor Xavier Leleu, I'm head of department of hematology specialized in myeloma, in France. And so at ASCO and IHA 2024, I have presented, I have made two talks. The number one is the BENEFIT study, so called IFM 2020.05, which is an attempt to improve newly diagnosed multiple myeloma patients transplant ineligible and to improve MAIA, the triplet daratumoma based regimen, daratumoma bledidomidexamethasone. So to improve MAIA, we have implemented a quadruplet based regimen, keeping the CD38 immunotherapy instead of daratumoma, we've been using esatuximab, lenalidomide and dexamethasone, plus the proteasome inhibitor, Bortezomib, a proteasome inhibitor that all the physicians in myeloma and I guess all the patients know. So the results of MAIA alongside IMROs, the two phase three studies that have studied quadruplet versus triplet, the study BENEFIT have provided, I would say, incredible data. Our primary endpoint was the MEd negativity rate at 10 to minus 5 at 18 months. And the results is that in the quadruplet based regimen, esatuximab, botazomib, and in the meds 53% of the patients had a negative MEd rate at 10 to minus 5 at 18 months. And 30% of them, approximately, were actually even negative at 10 to minus 6, which is much deeper, much more difficult to get. We don't have survival yet, it's too immature, but there is survival for IMROs, the results of IMROs being very close to BENEFIT. The safety profile is great, it's good, it's slightly more problematic when you add the botazomib, more thrombocytopenia, slightly more neurotoxicity peripheral neuropathy, slightly more edema of the lower limbs. However, besides this, we believe it was very, very manageable. One particularity of BENEFIT, which is different from IMROs, was that in BENEFIT, the Velcale was given weekly for 12 cycles, 1, 8, 15, of cycles 28 days long, and from 12 to 18 months it was given 1, 15. And we believe this way of giving the Velcade provided incredible data and was pretty safe for the patients in the quadruplet based regimen. That's for BENEFIT. And we think that IMROs and BENEFIT, the two first three studies looking at this quadruplet, the esatuximab, botazomib, linovendix, and tazone are going to become now the new start of care for patients newly diagnosed with myeloma, transplant ineligible, 65, 79 years old.
HealthTree • July 2, 2024