Varnimcabtagene Autoleucel Therapy Achieves Durable Remissions With Manageable Toxicity for R/R Follicular Lymphoma
Varnimcabtagene autoleucel (var-cel) demonstrated high response rates and sustained remissions among patients with relapsed/refractory (R/R) follicular lymphoma (FL), and significantly reduced financial burden and hospital admission time, according to updated study results from the CART19-BE-01 trial published in HemaSphere.
Due to limited access and the high cost of CAR T-cell products like tisagenlecleucel, axicabtagene ciloleucel, and lisocabtagene maraleucel, the anti-CD19 CAR T-cell product, varnimcabtagene autoleucel to may be an effective alternative treatment for R/R FL. Researchers conducted the CART19-BE-01 clinical trial to determine the safety and efficacy of varnimcabtagene autoleucel among patients with R/R FL who were ineligible for transplant or relapsed following autologous or allogeneic transplant.
Overall, 27 patients were treated with varnimcabtagene autoleucel and the median age was 61 years (range, 33 to 73). Among patients, the median lines of prior therapy was 3 (range, 2 to 9), with progression occurring within 24 months of initial frontline therapy for 56% of patients. The median follow-up was 17.9 months (range, 3.3 to 60.4).
At day +100 following infusion, the objective response rate (ORR) was 100% (95% confidence interval [CI], 87 to 100), including a complete response (CR) rate of 93% (95% CO, 76 to 99). At 3 years, the median DOR had not been reached and was 78% (95% CI, 62 to 98). The estimated progression-free survival rate was 78%, 95% CI, 62 to 98) and the estimated overall survival (OS) was 81% (95% CI, 65 to 100).
In terms of safety, 55% (95% CI, 35 to 75) of patients reported cytokine release syndrome (CRS) of any grade. Neutropenia grade 3 or higher occurred in 93% (95% CI, 76 to 99) of patients, while anemia grade 3 or higher occurred in 41% (95% CI, 22 to 61). Additionally, grade 3 or higher thrombocytopenia occurred in 44% (95% CI, 25 to 65) of patients treated with varnimcabtagene autoleucel.
The researchers concluded, “we believe that var‐cel holds promise for the treatment of adult patients with R/R FL.”
They added, “moreover, the toxicity of the product was manageable, both manufacturing and hospital admission times could be shortened, and the product was 3 to 4 times cheaper than axi‐cel or tisa‐cel, which reduced the burden for patients, families, healthcare providers, and payers.”
Source:
Núria Martínez‐Cibrián, Valentín Ortiz‐Maldonado, Español‐Rego M, et al. Efficacy and safety of the academic anti‐CD19 chimeric antigen receptor T‐cell product varnimcabtagene autoleucel for the treatment of relapsed/refractory follicular lymphoma. HemaSphere. Published online September 11, 2025. doi:10.1002/hem3.70166
