Cellectis Presents Promising Results for Lasmé-cel
Cellectis has announced encouraging results from phase 1 of the BALLI-01 clinical trial for lasmé-cel, targeting patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
Phase 1 Clinical Trial Outcomes
During its R&D Day, Cellectis presented the results of the phase 1 BALLI-01 clinical trial, which examines lasmé-cel in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). In this trial, lasmé-cel demonstrated an overall response rate (ORR) of 68% with Process 2 (P2), and 83% at the recommended Phase 2 dose (RP2D). The safety of lasmé-cel was assessed in 40 participants, showing generally favorable tolerance. A case of grade 2 immune effector cell-associated hemophagocytic syndrome was reported but resolved. Among patients in complete remission or complete remission with invasive residual disease (CR/CRi MRD-negative), the median overall survival reached 14.8 months, with 80% of subjects becoming MRD-negative.
Initiation of Pivotal Phase 2
Cellectis has initiated the pivotal phase 2 of the BALLI-01 study, targeting patients with relapsed or refractory B-ALL. This phase aims to confirm the potential of lasmé-cel as a 'bridge' treatment towards transplantation. The company plans to submit a Biologics License Application (BLA) in 2028. A panel of hematology experts was convened to discuss the potential of lasmé-cel to meet the unmet needs of heavily pre-treated patients. Additionally, a strategic partnership with AstraZeneca was highlighted to develop up to 10 new cell and gene therapy products.
Market Potential and Pricing Strategy
According to Cellectis, lasmé-cel could address up to about 1900 eligible patients in third-line and beyond by 2035, in the US, EU4, and the United Kingdom. The treatment could generate up to about $700 million in peak gross sales in 2035. An indication extension could increase this figure to about $1.3 billion. Cellectis has set a reference price of $365,000 for the EU4 and the United Kingdom, and $515,000 for the US in 2025, with an anticipation of an annual increase of 5% for the latter. The treatment of lasmé-cel is positioned to capture a significant share of the addressable market with an alternative target and 'ready-to-use' availability.
