Advertisement


Xavier P. Leleu, MD, PhD, on Multiple Myeloma: Update on Isatuximab, Lenalidomide, Dexamethasone, and Bortezomib

2024 ASCO Annual Meeting

Advertisement

Xavier P. Leleu, MD, PhD, of France’s Université de Poitiers and Centre Hospitalier Universitaire de Poitiers, discusses phase III findings showing that isatuximab in combination with bortezomib, lenalidomide, and dexamethasone deepened responses and increased the rate of measurable residual disease negativity vs isatuximab with lenalidomide and dexamethasone in patients with newly diagnosed transplant-ineligible multiple myeloma (Abstract 7501).



Transcript

Disclaimer: This video transcript has not been proofread or edited and may contain errors.
The current standard of care for newly diagnosed multiple myeloma, non-transplant eligible, but non-frail, usually patients from, let's say 65 to 79, 80 years old, is a triplet-based regimen called C38 Immunotherapy first in class [inaudible] plus Lenalidomide and Dexamethasone based on a study named MAIA that was for registration. And I guess most of the country in the world now use that triplet-based combination as standard of care. It has replaced a previous one called [inaudible]. We wanted to improve on the results, the main results, the most interesting results of MAIA, meaning the MRD negative rate, 10 to -5 threshold that was at 31% approximately, and we wanted to improve as well the survival that is at median at approximately five years, 62 months. So we created this phase three study, randomized one-to-one, two arms; one arm MAIA-like, but using Isatuximab, the second-in-class immunotherapy targeting CD38. isatuximab, lenalidomide, dexamethasone in the control arm, 135 patients versus isatuximab, lenalidomide, dexamethasone plus bortezomib, a protease inhibitor, first in class that we know for years and we know is extremely efficacious in myeloma in the study arm, a quadruplet-based regimen; again, 135 patients. The primary endpoint was the MRD-negativity rate at 10 to minus five at 18 months. And I'm not going to go through the secondary endpoint, the regular safety, survival types of response and other MRD endpoints. The results of the study are that we have met primary endpoint. The rate of MRD-negativity, 10 to minus five in the control arm, ISAL index was 26% similar to MAIA. It was more than 50%, 53% in the study arm, in the quadruplet-based regimen, which not only a positive study, because it was calculated initially at 30%, and it is more than 50, but it is even more than a positive study. It is a clinically meaningful improvement in MRD-negativity rate, because more than half of the patients actually reach MRD-negativity at 10 to minus five, which is unprecedented in myeloma in that population, in non-transplant eligible patients. The survival cannot be shared yet because it is immature. All of the patient have reached 18 months, but it is too early to talk about survival. Yet the safety profile was as expected; it was of course good, manageable. The bortezomib in that study was given weekly, so we have a lot improve the risk of side effects related to bortezomib. However, I have to disclose a slight increase in neurotoxicity. But overall, it was a quadruped regimen with a very interesting balance risk-benefit, given the incredible activity and given the slight increase in neurotoxicity in terms of safety profile. And so we believe that isatuximab, bortezomib, lenalidomide, dexamethasone, quadruped based regimen is the new standard of care and probably should replace the triple-based regimen that we were using before.

Related Videos

Kidney Cancer

Brian I. Rini, MD, on Renal Cell Carcinoma: Exploratory Biomarker Results

Brian I. Rini, MD, of Vanderbilt Ingram Cancer Center, discusses phase III findings of the KEYNOTE-426 study of pembrolizumab plus axitinib vs sunitinib for patients with advanced renal cell carcinoma. He details the exploratory biomarker results, including RNA sequencing, whole-exome sequencing, and PD-L1 (Abstract 4505).

Gynecologic Cancers

Don S. Dizon, MD, on Ovarian and Other Extrarenal Clear Cell Carcinomas: Update on Nivolumab and Ipilimumab

Don S. Dizon, MD, of Legorreta Cancer Center at Brown University and Lifespan Cancer Institute, discusses final phase II results of the BrUOG 354 trial showing that, for patients with ovarian and other extrarenal clear cell cancers, nivolumab and ipilimumab warrant further evaluation against standard treatment, given the historically chemotherapy-resistant nature of the disease (LBA5500).

Breast Cancer

Reshma Jagsi, MD, DPhil, and Tarah J. Ballinger, MD, on Early-Stage Breast Cancer in Black Women: Docetaxel and Peripheral Neuropathy

Reshma Jagsi, MD, DPhil, of Emory University Winship Cancer Institute, and Tarah J. Ballinger, MD, of Indiana University Simon Comprehensive Cancer Center, discuss the disparate burden of taxane-induced peripheral neuropathy in Black women with early-stage breast cancer and how a tailored trial for this population showed that using docetaxel as the preferred taxane may be beneficial (LBA503).

Multiple Myeloma

Luciano J. Costa, MD, PhD, on Multiple Myeloma: Subgroup Analysis of CARTITUDE-4 on Ciltacabtagene Autoleucel

Luciano J. Costa, MD, PhD, of the University of Alabama at Birmingham, discusses recent findings from the CARTITUDE-4 trial showing that, in patients with lenalidomide-refractory functional high-risk multiple myeloma after one prior line of treatment, ciltacabtagene autoleucel improved outcomes vs the standard of care (Abstract 7504).

Kidney Cancer

Laurence Albiges, MD, PhD, on Renal Cell Carcinoma: Biomarker Analysis of the IMmotion010 Study

Laurence Albiges, MD, PhD, of Gustave Roussy, Université Paris-Saclay, discusses phase III findings showing that high baseline serum KIM-1 levels were associated with poorer prognosis but improved clinical outcomes with atezolizumab vs placebo in patients with renal cell carcinoma at increased risk of recurrence after resection. Increased post-treatment KIM-1 levels were found to be associated with worse disease-free survival (Abstract 4506).

Advertisement

Advertisement




Advertisement