The submission was based on the P-I/II study (MonumenTAL-1) study evaluating talquetamab (off-the-shelf, bispecific T-cell engager Ab). The recent application was based on BLA submission in the US
Patients treated with talquetamab (SC, 0.4mg/kg, qw) achieved 74.1% ORR & 73.1% at 0.8mg/kg, q2w; VGPR or better (59.4% & 57.2%); CR (33.6% & 32.4%); sCR (23.8% & 20%); m-PFS (7.5mos. & not mature) at a median follow-up of 14.9 & 8.6mos., respectively. The study results were presented at ASH 2022
At both doses, AEs leading to the treatment discontinuation (4.9% & 6.2%); 8.4% & 13.8% had dose delays; 14.7% & 6.2% had dose reductions. Talquetamab received PRIME designation from the EMA in Jan 2021; BTD from the US FDA in June 2022; ODD in the EU & US in Aug & May 2021, respectively
Ref: Globe Newswire | Image: Janssen
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