ASH 2023 | BMS-986393 CAR T-cell therapy for R/R multiple myeloma: results of a Phase I trial

At this congress, we shared updated results for BMS-986393. This is a first-in-class GPRC5D-directed autologous CAR T-cell. 

What we presented at this congress was that we were able to share the recommended Phase II dose, which is 150 million CAR T-cells. We reached this dose without exceeding MTD, so I think that was encouraging. Overall, in about 84 patients who received the CAR T-cell so far, we have shown this to be a safe therapy with limited toxicities affecting the hair, skin, and nails. These were mostly low-grade, transient, and self-evolving. 

In terms of the efficacy data, we see that this CAR T-cell product, at the recommended Phase II dose, had an overall response rate of 91% and a complete response rate of 48%, which is very encouraging in this highly refractory patient population. Patients in this study had received a median of five prior lines of therapy. About 75% were triple-class refractory, 20% were BCMA refractory, and we had almost 41% of patients with high-risk cytogenetics and 44% of patients with extramedullary disease. Overall quite a refractory population, so it was encouraging to see high response rates.

Of course, we evaluated cytokine release syndrome in the setting of CAR T-cell products at the recommended phase two dose, which was present in about 89% of the subjects, but these were all grade one or two events, we did not see any grade three or higher cytokine release syndrome. We saw ICANS -most were low-grade events. We did see some cases of non-ICANS neurotoxicity, which are mostly symptoms such as dizziness, ataxia, or dysarthria that affected nine patients across the study so far. So far, you know, these appear to be dose-related and have shown some signs of reversibility with limited follow-up, and much of this needs to be continued to be followed up so we can understand better who are these patients and how do these toxicities evolve.