With so many great studies covered at ASH 2019, what will take home the honors for the best outstanding oral presentation? Will it be a Chimeric Antigen Receptor (CAR) or Bispecific T-cell Engager (BiTEs) trials, or will it be a new four-drug combination trial? How about one study that has a 100% response rate in myeloma patients? That alone sounds incredible!
A potential trial with a low profile of side effects as controllable cytokine release syndrome (CRS) and almost no neurological effects. This trial is for patients who have had 5 to 18 failed therapies and demonstrate persistent active disease. These patients have a poor response to immunomodulators, proteasome inhibitors, and to anti-CD38 infusion, confirming a relapsed/refractory state. This sounds incredible for a study that has an equal number of males and females who were triple- and penta-refractory to various therapies. Dr. Deepu Madduri presented a multi-center CAR-T Cell trial, JNJ-4528, containing two antibodies directed at BCMA on the myeloma cell. This study has shown a high overall response, and patients in the study expanded their T-cells; these T-cells maintain a longer memory.
My choice for the most important oral presentation would be the CARTITUDE-1 study. Aside from my fondness for the name, how could one argue with the results? I am anxious to know the results of the phase II and phase III studies to which patients are currently enrolled. I am very interested to know what’s in store for these patients over time. Clearly, I am not the only one impressed with these results as the FDA has recently given JNJ-4528 “BREAKTHROUGH” status.