ASH 2024 | Comparing the safety and efficacy of cilta-cel and ide-cel in R/R myeloma using real-world data

Yeah, so we currently have two FDA-approved CAR T-cell products. We have ciltacabtagene autoleucel, cilta-cel, and axicabtagene ciloleucel, or axi-cel. However, you know, the single-arm studies or the pivotal studies that led to their approvals show some differences in terms of responses, in terms of toxicity, particularly delayed neurologic toxicity, as well as survival. So we really set out to compare, in a standard of care setting, the efficacy of these products. And this is in lieu of a prospective randomized control clinical trial, such a thing is not available, so we need more information to select the right product for patients and to educate patients about one CAR-T versus the other. 

This was a multi-center analysis – about 19 sites or academic centers within the United States participated. We had about 641 leukapheresed patients and 586 infused patients. The primary analysis involved inverse probability of treatment weighting. This is a type of propensity score matching that allows us to balance measured confounders across treatment arms while preserving the cohort size. 

The main results of the study essentially found that cilta-cel patients were more likely to experience severe cytokine release syndrome, infections, and delayed neurotoxicity. There was a trend for increased second primary malignancies, but this did not reach statistical significance. There was also a slightly higher rate of non-relapse mortality (NRM) for cilta-cel, but this, again, did not reach statistical significance, and the most likely or the most common cause for NRM was CRS and infections. 

In terms of response, although cilta-cel may have a higher incidence of certain toxicities, it is also associated with a higher response rate, particularly complete response or better and significantly improved progression-free survival and overall survival, both overall in the entire patient population, but also among high-risk patient subgroups. 

I think, in summary, the study does provide at least the most comprehensive and thorough comparison that we can do between these commercial products. Certainly, there are limitations. It is a retrospective analysis and not a prospective randomized trial. There are unknown unknowns and biases inherent in real-world data, but we hope that this study will provide some information in terms of aiding clinical decision-making, patient counseling, as well as guiding selection of CAR T-cell products.

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