welcome to OncLive On AirTM! I am your host today, Kristi Rosa.
OncLive On AirTM is a podcast of OncLive, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers all aspects of oncology practice, from new technologies and therapeutic advances to important regulatory decisions.
In today’s episode, we had the pleasure of speaking with C. Ola Landgren, MD, PhD, professor of medicine; head of the myeloma program in the hematology division; and Head of the Experimental Therapy Program at the Sylvester Comprehensive Cancer Center, University of Miami Health System, to discuss the Phase 2 MANHATTAN trial examining a new quadruplet regimen in patients with newly diagnosed multiple myeloma .
The trial examined whether adding daratumumab (Darzalex) to weekly carfilzomib (Kyprolis) plus lenalidomide (Revlimid) and dexamethasone would result in high levels of minimal residual disease (MRD) negativity in the absence of chemotherapy at high dose and transplant. Investigators also sought to establish the security of the regime.
The data showed that the rate of MRD negativity of 40% or more after up to 8 cycles of the weekly combination was achieved by 71% of 41 patients, meeting the primary endpoint of the trial. Additionally, the median time to MRD negativity was 6 treatment cycles.
The 4-drug regimen was also found to induce an overall response rate of 100% and a very good partial response or a complete response rate of 95%. For individual patients, the response obtained with the diet was noted to deepen over time. At a median of 11 months of follow-up, the 1-year progression-free survival rate with the regimen was 98%, with a 1-year overall survival rate of 100%.
In terms of safety, the most common grade 3 or 4 side effects seen with the combination included neutropenia, rash, and lung infections. Serious diet-related toxicities were reported in 18% of patients; however, no deaths have been reported.
In our exclusive interview, Dr. Landgren discussed in more detail the trial, the potential of the 4-drug regimen in this population, and the next steps in this research.