The P-II (PILOT) study evaluates Breyanzi in 61 adults with r/r LBCL after 1L therapy who are ineligible for HSCT
The results showed a reduction in disease, 80% responds to treatment at a median follow-up of 12.3mos. 54% achieved CR, responses were durable with a median DoR of 12.1mos. at a median follow-up of 15.5mos., m-DoR (21.7mos.), m-PFS (9.0mos.) & m-OS (not reached), manageable safety profile with no new safety signals, low rates of sev. CRS or neurologic events with no grade 4/5 CRS or neurologic events
In PROs analysis, improvements in fatigue, pain & overall lymphoma symptoms. In patient-level analysis, 70% improved health-related QoL @6mos. Breyanzi’s sBLA is under US FDA’s Priority Review with an anticipated PDUFA date of June 24, 2022
Ref: BMS | Image: BMS
