William G. Wierda, MD, PhD, on Lisocabtagene Maraleucel in Relapsed/Refractory CLL: TRANSCEND CLL 004

Confirmed — I have only corrected spelling errors and left all wording unchanged. Here is the revised transcript as one continuous paragraph: I'd like to summarize 2 posters that I'm presenting at ASCO this year. Poster 7039 and 7037—7039 is a poster that presents an updated analysis of liso-cel monotherapy and its analysis of a comparison of a standard of care cohort of patients that was collected through multiple databases. Those were all previously treated patients and the concept is to compare outcomes for liso-cel and patients with similar characteristics as those treated on the TRANSCEND 004 trial who received standard of care treatment and their outcomes versus the outcomes for patients treated with liso-cel monotherapy on the TRANSCEND CLL 004 trial. That analysis showed improved outcomes for patients who were treated with liso-cel. These were all previously treated patients, all had had prior exposure to a BTK inhibitor and the BCL2 inhibitor-based therapy. And the progression-free survival was significantly better at a median of 14 months with liso-cel compared to about four months with a standard of care option. And the overall survival was improved with a median overall survival for liso-cel of 33 months and the median overall survival for standard of care of about 14 months. And so this analysis and comparison in the absence of a randomized trial gives us some insight into the improved outcome seen with liso-cel monotherapy compared to a standard of care option. The other abstract is 7037. This was an analysis with a propensity score comparing outcomes for patients treated with liso-cel monotherapy, the CD19 CAR T-cell therapy, versus liso-cel with ibrutinib. Now there is data, historic data, that demonstrated an improved product could be generated if the T cells were harvested for production while patients were on ibrutinib. In addition, for patients treated with liso-cel or with a CD19 CAR T-cell therapy while on ibrutinib, there was an indication of improved progression-free survival and overall outcomes and a reduction potentially of side effects and toxicities. So this analysis was a comparison because the TRANSCEND CLL 004 trial has two cohorts—actually it had three cohorts—but two major cohorts, liso-cel monotherapy and liso-cel plus ibrutinib. And this was an analysis. And overall, the conclusion was that there were improved responses, both complete response rate and overall response rate, for patients who received the combination of liso-cel plus ibrutinib versus patients who received liso-cel monotherapy. Progression-free survival, duration of response, overall survival were similar; side effect and toxicity profile were similar. But clearly there was, based on this propensity score analysis, an improved response rate associated with combination therapy versus liso-cel monotherapy.