A controlled analysis using historical data published in Blood Advances suggests that tisagenlecleucel (tisa-cel) may improve clinical outcomes compared with usual care among patients with relapsed or refractory follicular lymphoma (FL).

Relapsed/refractory FL represents a serious clinical challenge and patient population with a currently unmet need of therapeutic options. Tisa-cel, an anti-CD19 chimeric antigen receptor (CAR)-T cell therapy, may represent such an option, and is being investigated in the phase 2 ELARA trial (ClinicalTrials.gov Identifier: NCT03568461).

While ELARA is a single arm study, it has shown high overall response rates among patients with relapsed/refractory FL, including among patients with high-risk disease. The complete response rate in the study was shown to be 69%.


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It was, however, previously unknown whether tisa-cel improves outcomes compared with those seen in historical populations worldwide who receive usual care in this setting. For this study, researchers aimed to compare clinical findings from ELARA with those seen in usual care among patients with relapsed/refractory FL.

Data from 97 patients included in ELARA and 99 historical controls (the ReCORD-FL sample, after weighting) were included. At baseline, the mean ages were 56.5 and 56.1 years, respectively, and 34% and 30.8% of patients were female gender; the median number of prior therapy lines was 4 in both groups.

Analysis showed that the adjusted complete response rates were 69.1% (95% CI, 59.8%-78.3%) in the tise-cel group vs 37.3% (95% CI, 26.4%-48.3%) in the usual care group; the overall response rates were 85.6% (95% CI, 78.7%-92.5%) and 63.6% (95% CI, 52.5%-74.7%), respectively.

The researchers also found that the 12-month probabilities for progression/event-free survival were 70.5% (95% CI, 61.4%-79.7%) in the tisa-cel group compared with 51.9% (95% CI, 40.6%-63.3%) for usual care. The hazard ratio for 12-month overall survival was 0.2 (95% CI, 0.02-0.38), strongly favoring tisa-cel.

“In conclusion, this study provides further context to the results of the single-arm ELARA trial by providing needed historical control data from clinically similar patients receiving usual care in routine practice settings,” the authors wrote in their report.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, or device companies. Please see the original reference for a full list of authors’ disclosures. 

Reference

Salles G, Schuster SJ, Dreyling M, et al. Efficacy comparison of tisagenlecleucel vs usual care in patients with relapsed or refractory follicular lymphoma. Blood Adv. 2022;6(22):5835-43. doi:10.1182/bloodadvances.2022008150