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Impact of Prior Inotuzumab Ozogamicin Treatment on Brexucabtagene Autoleucel outcomes in Adults with B-cell ALL.

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Impact of Prior Inotuzumab Ozogamicin Treatment on Brexucabtagene Autoleucel outcomes in Adults with B-cell ALL. Blood advances Aldoss, I., Roloff, G. W., Faramand, R. G., Kopmar, N. E., Lin, C., Advani, A. S., Dekker, S. E., Gupta, V. K., O'Connor, T. E., Jeyakumar, N., Muhsen, I. N., Valtis, Y. K., Zhang, A., Miller, K., Sutherland, K. C., Dykes, K. C., Ahmed, M., Chen, E. C., Zambrano, H., Bradshaw, D., Mercadal, S., Schwartz, M. S., Tracy, S. I., Dholaria, B., Kubiak, M. J., Mukherjee, A., Majhail, N. S., Battiwalla, M., Mountjoy, L., Malik, S. A., Mathews, J., Shaughnessy, P. J., Logan, A., Ladha, A., Stefan, M., Guzowski, C., Hoeg, R. T., Hilal, T., Moore, J., Connor, M., O'Dwyer, K. M., Hill, L. C., Tsai, S. B., Sasine, J. P., Solh, M. M., Lee, C. J., Kota, V., Koura, D., Veeraputhiran, M., Blunk, B., Oliai, C., Leonard, J. T., Frey, N. V., Park, J. H., Luskin, M. R., Bachanova, V., Galal, A., Bishop, M. R., Stock, W., Cassaday, R. D., Pullarkat, V. A., Shah, B. D., Muffly, L. 2024

Abstract

The effect of prior inotuzumab ozogamicin (InO) treatment on brexucabtagene autoleucel (brexu-cel) outcomes remains unclear in adults with acute lymphoblastic leukemia (ALL), particularly the influence off previous InO response and the timing of administration. We conducted a retrospective multicenter analysis of 189 patients with relapsed/refractory (r/r) ALL treated with brexu-cel. Over half of the patients received InO before brexu-cel (InO-exposed). InO-exposed patients were more heavily pretreated (p= 0.02) and frequently had active marrow disease pre-apheresis (p= 0.03). Response rate and toxicity profile following brexu-cel were comparable for InO-exposed and InO-naive; however, consolidation therapy post brexu-cel response was utilized at a higher rate in InO-naive patients (p= 0.005). With a median follow up of 11.4 months, InO-exposed patients had inferior progression-free survival (PFS) (p=0.013) and overall survival (OS) (p=0.006) in univariate analyses; however, prior InO exposure did not influence PFS (HR 1.20, 95%CI, 0.71-2.03) in multivariate models. When InO-exposed patients were stratified according to prior InO response, InO responders had superior PFS (p=0.002) and OS (p<0.0001) relative to InO-refractory. The timing of administering InO did not affect brexu-cel outcomes, with comparable PFS (p=0.51) and OS (p=0.86) for patients receiving InO as bridging therapy or pre-apheresis. In conclusion, while InO exposure was associated with inferior survival outcomes following brexu-cel in unadjusted analyses, these associations were no longer significant in multivariate analyses, suggesting it is unlikely that InO negatively impacts brexu-cel efficacy. Our data instead imply that InO-exposed recipients of brexu-cel tend to be higher-risk patients with intrinsic adverse leukemia biology.

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