Liso-Cel Shows Clinical Benefit in Relapsed/Refractory LBCL

Jeremy Abramson, MD, director of the Center for lymphoma at Massachusetts General Cancer Center, associate professor of medicine at Harvard Medical School, discusses findings from the TRANSFORM study (NCT03575351) of lisocabtagene maraleucel (liso-cel; Breyanzi) vs standard of care treatment in patients with relapsed or refractory large B-cell lymphoma (LBCL).

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0:10 | We randomized 92 patients to each arm of the study. Our study confirmed the superiority for liso-cel over the standard of care. Our primary end point was event-free survival, which was not reached for the liso-cel arm and was only 2 months for standard of care. At 18 months, which was our median duration of follow-up, the 18-month event-free survival was 54% for liso-cel and only 21% for standard of care. Our secondary end points were also consistently in favor of liso-cel. The complete response rate was significantly improved favoring liso-cel with a complete response rate of 74% for liso-cel patients, which was far superior to those on platinum-based chemotherapy, and the median duration of complete response was better for patients who achieved a [complete response] on the liso-cel arm.

1:05 | We saw an improved progression-free survival with a 60% reduction in risk of progression or death favoring liso-cel over standard of care, and we saw a trend in favor of an overall survival benefit with a numerically better overall survival in liso-cel, even though 2/3 of patients assigned to standard of care had crossed over as of the time of this analysis.

1:29 | As a result, we performed a supportive overall survival analysis using a 2-stage accelerated failure time model to adjust for the impact of crossover. When adjusting for the impact of crossover, we [found] a superior overall survival favoring liso-cel over a standard of care with a hazard ratio of 0.43. We found significant superiority in terms of event-free survival, complete response rate, and progression-free survival, as well as overall survival after adjusting for crossover favoring liso-cel over the historic standard therapy.