Shots:

• The company has submitted the BLA to the US FDA for talquetamab, an off-the-shelf, bispecific T-cell engager Ab targeting both GPRC5D for r/r MM. The BLA was based on the P-I/II (MonumenTAL-1) study evaluating talquetamab
• As of data cut off May 16, 2022, ORR was 73% in 143 patients treated at 0.4mg/kg, qw, responses were & deepened over time, the median time to response was 1.2mos., the median time to CR was 2.1mos., m-DOR (9.3mos.), m-PFS (7.5mos.), ORRs in patients who were triple-class refractory (72%) and Penta-drug refractory (71%) over the overall population, no significant effect on PK, efficacy, or AEs were seen. The results were presented at ASH 2022 in an oral scientific session
• Talquetamab received BTD from the US FDA for r/r MM & also received ODD from the US FDA & EC

Ref: PRNewswire | Image: Janssen