The IRC-assessed overall response rate in the leukapheresed population (N=287) was 59% (95% CI: 53, 64), with a CR rate of 43% (95% CI: 37, 49) and PR rate of 15% (95% CI: 11, 20).1*
Efficacy was established on the basis of CR rate and DOR, as determined by an Independent Review Committee per the Lugano 2014 criteria.
Breyanzi is administered as a one-time treatment1†
* Of the 287 patients who underwent leukapheresis and had radiographically evaluable disease, 27 additional patients achieved a response, apart from the responses noted in graph above. These efficacy results include responses that may have been contributed solely by bridging therapy, product outside of the intended dose range, and out-of-spec product.
†Treatment process includes leukapheresis, manufacturing, administration, and adverse event monitoring. A single dose of Breyanzi is 90 to 110 × 106 CAR-positive viable T cells for LBCL after 1 line of prior therapy, and 50 to 110 × 106 for LBCL after 2 or more lines of therapy (consisting of 1:1 CAR-positive viable T cells of the CD8 and CD4 components), with each component supplied separately in 1 to 4 single-dose vials.
Breyanzi demonstrated rapid and durable remission1
|Number of responders (n=141/192)1
||Median months (95% Cl)
||16.7 (5.3, NR),‡ range§: 0.0+ to 23.5+
|DOR if best
response is CR
|NR (16.7, NR),‡ range§: 0.7+ to 23.5+
|DOR if best
response is PR
|1.4 (1.1, 2.2),‡ range§: 0.0+ to 22.8+
One-month median time to first CR (range: 0.8-12.5 months)
‡ Kaplan-Meier method was used to obtain 2-sided 95% confidence intervals.
§ A plus sign (+) indicates a censored value.
Breyanzi offers a potentially definitive treatment1
DOR by best overall response; median DOR: 16.7 months3