Long-term Follow-up from Qualitative Interviews of Patients with Relapsed or Refractory Large B-Cell Lymphoma on Their Treatment Experience While Enrolled in a Lisocabtagene Maraleucel Study

Background: Patients(pts) with R/R large B-cell lymphoma (LBCL) have rapid and durable responses when treated with lisocabtagene maraleucel (liso-cel), a CD19-directed CAR T cell therapy. The safety profile is manageable with low rates of grade ≥ 3 cytokine release syndrome, neurological events, and infections and no new safety signals after long-term follow-up (Abramson JS, et al. Blood 2021). Qualitative pt interviews can generate meaningful data to gain deeper understanding of the treatment (tx) experience and benefit from the pt perspective, help interpret pt-reported outcome (PRO) scores, and help identify what is most important to pts. Previous qualitative pt interviews within the context of a clinical trial showed positive pt experience in the first 3 months after liso-cel infusion (Siddiqi T, et al. Blood 2021). This analysis assessed pt perceptions of liso-cel tx 6‒24 months after infusion.

Methods: Pts with R/R LBCL treated with liso-cel in a single-arm phase 2 study (TRANSCEND WORLD [NCT03484702]) had an option to participate in a series of semistructured guided interviews that included 5 close-ended questions. Interviews were conducted by trained researchers independent of the trial and were audio recorded and transcribed. Analyses included thematic analysis, quantitative descriptive analysis of close-ended items, and qualitative longitudinal analysis. Interviews were conducted at baseline (before leukapheresis), after leukapheresis and before infusion; in the 3 days after infusion; and at 1, 2, 3, 6, 9, 12, 18, and 24 months after infusion. Results from Months 6‒24 are presented.

Results: Overall, 48 interviews were analyzed across 21 unique pts (8 from Spain; 4 from France; 3 from Austria; 2 from Finland; and 1 each from Germany, Italy, Japan, and the Netherlands). Mean age was 62 years, and the sample was 62% male. Most interviews were conducted in the first year: 12 at Month 6, 18 at Month 9, 10 at Month 12, 4 at Month 18, and 4 at Month 24. Whereas all pts (n = 21, 100%) reported ≥ 1 tx-related advantage between Months 6 and 24, 71% (n = 15) reported ≥ 1 tx-related disadvantage. The most common advantages included benefits regarding the lack of side effects (SEs) or the minor nature of SEs (n = 19, 90%) and efficacy (n = 18, 86%) associated with liso-cel. Fewer pts mentioned SEs associated with liso-cel (n = 10, 48%) and lack of efficacy (n = 7, 33%) as disadvantages. When specifically compared with other txs received (eg, transplant, radiation, chemotherapy, and unspecified txs), liso-cel was most often considered more advantageous in terms of favorable efficacy and SEs. The majority of pts (n = 15, 71%) described ≥ 1 advantage related to trial conduct (eg, quality of site staff), short time needed for infusion, or frequent medical care from follow-ups. Most pts (n = 15, 71%) also described ≥ 1 trial-related disadvantage, including the burden of safety monitoring and uncertainty about long-term outcomes. Between baseline and each time point, pts who received liso-cel as their only tx while enrolled in the trial either improved more often than they worsened or maintained stability in health and well-being areas of “physical capacity and day-to-day life” and “future outlook” (n = 14, 67%). Pts most frequently maintained stability over the course of the trial in areas of “feelings and mood,” “family, friends, and leisure,” “work and career,” and “income and expenses.” There were no clear trends in change over time for the area of “physical health.” In 2 separate interview questions, pts were asked to rate the benefits and negatives of liso-cel tx on a 0‒10 scale (0 = none; 10 = tremendous). Mean benefits score ranged from 7.28 at Month 12 to 9.25 at Month 24. Negative ratings were at the low end of the scale; mean score ranged from 1.33 at Month 6 to 3.17 at Month 18. At each time point, most pts (58%‒78%) reported that benefits outweighed negatives, and ≥ 75% reported that they would make the same decision to receive liso-cel. Between 50% and 100% of pts also stated they would recommend the trial to a friend.

Conclusions: This study provides unique insights into the pt experience during the 2-year follow-up after liso-cel infusion that complement PRO data and provide a qualitative assessment of change over time. Pts generally reported positive tx experiences, improvements or stability in quality of life, and that they would repeat their decision to receive liso-cel.