Shots:
- The CHMP has recommended approval of an indication extension for Johnson & Johnson’s Talvey (talquetamab) + daratumumab ± pomalidomide for adults with relapsed/refractory multiple myeloma (RRMM) who have received ≥1 prior therapy; if approved, it will be the only GPRC5D-targeting bispecific antibody combination for RRMM as early as 2L
- Recommendation was based on the P-III (MonumenTAL-3) study (N=864) of Tal-DP & Tal-D vs DPd; at a median follow-up of 24.6mos., PFS improved (HR: 0.28 & 0.33), with 24mos. PFS rates of 81.3% & 77.6%, while OS also improved (HR: 0.47 & 0.51), with 24mos. OS rates of 89.2% & 87.9%, respectively
- ORR (88.2% & 88.5% vs 77.6%), ≥CR (71.1% & 68.9% vs 34.5%) & MRD-negative ≥CR (52.3% & 46.3% vs 15.9%) were higher vs DPd, with safety consistent with each monotherapy; Talvey is a CD3 x GPRC5D bispecific T-cell engager with EU conditional approval (Aug 2023) as monotherapy after ≥3 prior therapies
Ref: Johnson & Johnson | Image: Johnson & Johnson | Press Release
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