Janssen Presents Updated Results Evaluating First-in-Class Talquetamab (GPRC5DxCD3 Bispecific Antibody) in Heavily Pretreated Patients with Multiple Myeloma

ATLANTA, Ga., December 11, 2021– The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated results from the MonumenTAL-1 Phase 1 first-in-human dose-escalation study of talquetamab (NCT03399799). Talquetamab is the only investigational off-the-shelf T cell redirecting bispecific antibody in clinical development targeting both GPRC5D, a novel multiple myeloma target, and CD3 on T cells.[1] Results from the study show that no new safety signals were observed with longer follow-up.1 Heavily pretreated patients with multiple myeloma treated with talquetamab at the recommended subcutaneous (SC) Phase 2 doses (RP2D) administered weekly (QW) and every two weeks (Q2W) achieved high overall responses that deepened over time.1 These data were featured during the American Society of Hematology (ASH) 2021 Annual Meeting as an oral presentation (Abstract #158).1 No new safety signals were identified with longer follow-up of either dose cohort.1 The most common adverse events (AEs) at the SC 405 µg/kg QW dose were cytokine release syndrome (CRS – 77 percent; three percent grade 3), neutropenia (67 percent; 60 percent grade 3/4) and dysgeusia (60 percent).1 Dysgeusia was generally mild with few dose adjustments required. The most common AEs at the SC 800 µg/kg Q2W dose were CRS (72 percent; all grade 1/2), neutropenia (44 percent; 36 percent grade 3/4), and dry mouth (40 percent; all grade 1/2).1 Cytopenias were mostly confined to step-up doses and cycles o...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news