USFDA2 Jun 2025, 06:41 pm
Glenmark Pharmaceuticals' ISB 2001 Shows High Response Rates, Favorable Safety Profile in Relapsed/Refractory Multiple Myeloma
AI Summary
Glenmark Pharmaceuticals' ISB 2001, a first-in-class BCMA x CD38 x CD3 trispecific antibody, has shown continued high response rates and a favorable safety profile in the treatment of relapsed/refractory multiple myeloma. The TRignite-1 study showed an overall response rate (ORR) of 74% across nine dose levels in heavily pretreated patients with a median of six prior lines of therapy. The ORR was remarkably high in patients with no prior CAR-T or bispecific therapies (84%). The safety profile continues to be favorable, with the majority of patients remaining on treatment at data cutoff. The FDA recently granted ISB 2001 Fast Track Designation.
Key Highlights
- ISB 2001 shows an overall response rate (ORR) of 74% across nine dose levels in heavily pretreated patients with a median of six prior lines of therapy
- ORR is remarkably high in patients with no prior CAR-T or bispecific therapies (84%)
- Safety profile continues to be favorable, with the majority of patients remaining on treatment at data cutoff
- FDA recently granted ISB 2001 Fast Track Designation