Sunday brought so many exciting advances in investigating different facets of things that affect patient’s quality of life. I can truly say that during ASH, I heard researchers thank patients and their families an innumerable number of times. Researchers understand the impact that clinical trials have on patients and their families and value that sacrifice and truly do focus on improving patient’s daily lives in so many different ways.
Aurore Perrot, MD, PhD, from Toulouse, France, presented long-term data on patient reported outcomes (PRO’s) and QoL (quality of life) assessments from the MAIA trial. The phase 3, MAIA data showed that the addition of daratumumab to Revlimid and dexamethasone (Rd) has been shown to significantly improve both progression free survival (PFS) and overall survival (OS) vs Rd alone in transplant ineligible patients with newly diagnosed myeloma, with an estimated PFS rate of 53% and OS rate of 66% at 5 years. Dr. Perrot presented clinically meaningful improvements in PROs with D-Rd vs Rd as well. A key item to point out is subject compliance with QoL assessments in long term follow-up. QoL data is so important, but it can only be obtained if patients follow through to complete the assessments for the entire length of the trial. Impressively, the median follow-up of Dr. Perrot’s research was 64.5 months. QoL assessments and PROs should always be included in research, when appropriate, in my opinion. Isn’t this the true reason for our research?
Additionally, Rebecca Silbermann, MD, MMS, from Knight Cancer Institute at Oregon Health & Science University, presented PROs from the GRIFFIN trial at final study analysis after all patients completed 1 year of follow-up post-maintenance, with a median follow up of 49.6 months. As a patient advocate, I am so grateful for more researchers focusing their work on patient-centric data.
Also of interest on Sunday was a study looking at a new drug class altogether. Modakafusp alfa is a first-in-class, innate immunity enhancer that functions through targeted next-generation Interferon (IFN) signaling. The process of determining safest and most effective dose and dosing interval is fascinating. Dan Vogl, MD, from the University of Pennsylvania eloquently presented the final results from this Phase ½ study of Modakafusp alfa in patients with relapsed/refractory (R/R) myeloma. Of the 100 patients studied, their prior lines of therapy ranged from 3 to 19. This is mind boggling, but exciting at the same time, that we are researching new drug classes to help make a difference for this patient population. I am looking forward to the continued study of this drug and others for R/R myeloma.
The last study that I will comment on here was presented by Luciano Costa, MD, PhD, from the University of Alabama at Birmingham Hospital presented very important results from the first phase 1 clinical study of the BCMA Nex T CAR-T cell Therapy Orva-cel in heavily pretreated relapsed and refractory myeloma patients. This NEX-T process was designed to shorten historically long manufacturing time and improve the potency and phenotypic attributes of the product. This is absolutely exciting research as the CAR-T manufacturing process currently is quite long, especially for these heavily pretreated patients who are so hopeful and ready for this treatment.
Talk about giving hope to myeloma patients…no matter where they are in their journey with this disease!
You must be logged in to post a comment.