Shots:

• The P-II trial for r/r FL & P-I trial for r/r MCL evaluated Breyanzi in 213 & 385 patients. In the P-II trial, ORR (97%) in efficacy evaluable patients in the 3L+ setting, CR (94%), responses were durable, m-DoR (not reached) at a median follow-up of 16.6mos.
• 81.9% of responders had an ongoing response @12mos., m-PFS (not reached) at a median follow-up of 17.5mos., 12mos. PFS (80.7%). In the P-I trial at a median on-study follow-up of 16.1mos., ORR (86.5%) in efficacy evaluable patients in the primary analysis set, CR (74.3%)
• In the safety set, any grade CRS & NEs (58% & 15%) in the P-II trial and 61% & 31% in the P-I trial; grade 3 CRS & NEs (1% & 5%) and 1% & 9% in grade 3/4 CRS & NEs with no grade 4/5 CRS & NEs in P-II trial & no grade 5 CRS & NEs in P-I study. Both studies showed a manageable safety profile with no new safety signals & low rates of sev. CRS & neurologic events

Ref: BMS | Image: BMS

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