642. CLL: Therapy, excluding Transplantation II

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Anthony R. Mato, John M. Pagel, Catherine C. Coombs, et al.

Authors Conclusion from the Abstract: LOXO-305 demonstrated promising efficacy in heavily pretreated, poor-prognosis CLL/SLL pts following multiple prior lines of therapy including covalent BTKi and a BCL2 inhibitor. Importantly, the activity of LOXO-305 was not restricted to pts with BTK C481 mutations. LOXO-305 was well tolerated and exhibited a wide therapeutic index.

John G. Gribben, Wojciech Jurczak, Ryan Jacobs, et al.

Authors Conclusion from the Abstract: UNITY-CLL is the first randomized Phase 3 study in CLL of a PI3Ki vs. chemoimmunotherapy, and the first randomized study of a PI3Ki in treatment-naive CLL. U2 exhibited a well-tolerated safety profile, and significantly improved PFS vs. standard of care chemoimmunotherapy in patients with treatment-naive and relapsed/refractory CLL.

William G. Wierda, Kathleen A. Dorritie, Javier Munoz, et al.

Authors Conclusion from the Abstract: Preliminary data show that liso-cel in combination with ibrutinib is associated with manageable safety, including a low incidence of grade 3 CRS and grade ≥3 NEs, and promising efficacy in heavily pretreated patients with R/R CLL/SLL. No clear difference in safety was observed across DLs, and DL2 was selected as the RD for liso-cel in combination with ibrutinib in patients with R/R CLL/SLL. Updated results from the full combination cohort and additional PK/pharmacodynamic data will be reported.

Ohad Benjamini, Avichai Shimoni, Michal Besser, et al.

Authors Conclusion from the Abstract: CD19-CART-cell therapy in CLL patients with disease transformation is safe and has high complete remission rate with promising clinical response. Long term remission rate after CD19-CART-cell therapy for RT needs to be further evaluated in more patients.

Tanya Siddiqi, Jacob D. Soumerai, Kathleen A. Dorritie, et al.

Authors Conclusion from the Abstract: Liso-cel treatment resulted in a high rate of uMRD in this heavily pretreated, high-risk population of patients with R/R CLL/SLL, including those refractory to both a BTKi and venetoclax. Responses were rapid and durable, with liso-cel detectable for up to 18 mo postinfusion. No late or delayed adverse events of concern emerged with longer follow-up. The phase 2 monotherapy expansion of the study is currently enrolling at DL2.

Anthony R. Mato, Jacqueline C. Barrientos, Jeff P Sharman, et al.

Authors Conclusion from the Abstract: The informCLL registry provides an opportunity to prospectively assess CLL treatment patterns in the era of novel agents. The most common index treatment was ibrutinib and the majority of ibrutinib-treated pts remained on therapy at 2 y follow-up; CIT (primarily BR) was also used for one-third of patients. Prognostic biomarker testing rates were poor, especially for TP53 and IGHV mutational status. Data from informCLL also indicate a ‘knowledge gap’ in terms of prognostic marker testing and selection of therapies for pts with high-risk disease. Data from the now complete pt population and with continued follow up will allow for the ongoing evaluation of real-world treatment decisions and pt care that cannot be addressed by data from randomized clinical trials.