Updated results with liso-cel underscore potential for best-in-class CAR T profile for patients with poor prognosis
"As liso-cel data mature, the durable response rates continue to
demonstrate the potential of CAR T cell therapy in patients with DLBCL
who have relapsed or are refractory to prior treatments," said principal
The update provided today was based on a cutoff date of
At six months, 49% of patients remained in remission, with 46% maintaining a complete response (CR) in this cohort (n=37). When durability of response beyond six months was evaluated across all dosing levels ranging from 5 x 107 to 1 x 108 CAR T cells, 93% of patients in CR remained in CR at data cut off. Liso-cel therapy was available for 99% (132/134) of patients apheresed.
The most common treatment-emergent adverse events that occurred at ≥25% incidence included neutropenia (63%), anemia (53%), fatigue (46%), thrombocytopenia (34%), decreased appetite (29%), nausea (28%), hypotension (26%), cough (26%), headache (25%), dizziness (25%), constipation (25%), and diarrhea (25%). Cytokine release syndrome and neurotoxicity were observed at a rate of 37% and 23% for all grades, and 1% and 13% for grades 3 and 4, respectively (n=102). Based on this emerging safety profile, outpatient administration is being evaluated in the TRANSCEND trial.
"The updated efficacy and tolerability data for liso-cel continue to
support a potential best-in-class CD19 CAR T profile," said
About Liso-cel and TRANSCEND
Liso-cel is an investigational defined composition CD19-directed CAR T cell product candidate using a 4-1BB costimulatory domain. TRANSCEND is an open-label, multicenter phase I study to determine the safety, pharmacokinetics, and antitumor activity of liso-cel in adult patients with relapsed or refractory diffuse large B cell lymphoma, primary mediastinal B-cell lymphoma, follicular lymphoma Grade 3B, and mantle cell lymphoma.
The pivotal cohort includes patients with DLBCL (NOS and transformed from follicular lymphoma) who are ECOG Performance Status 0-1. These patients represent a high-risk patient population, with approximately 90% of treated patients having one or more predictors of poor survival, including double or triple hit lymphoma, being chemorefractory to front-line or subsequent therapies, never reaching a complete remission with prior treatments, or never having undergone an autologous transplant.
This press release contains forward-looking statements, which are
generally statements that are not historical facts. Forward-looking
statements can be identified by the words "expects," "anticipates,"
"believes," "intends," "estimates," "plans," "will," "outlook" and
similar expressions. Forward-looking statements are based on
management's current plans, estimates, assumptions and projections, and
speak only as of the date they are made.
Hyperlinks are provided as a convenience and for informational
News Provided by Acquire Media