CA073-1020_GOLSEEK-1 (BMS)

Description

randomized Phase 3 study of Golcadomide in combination with R-CHOP vs placebo in combination with R-CHOP in patients with previously untreated high risk LBCL

Objectifs principaux

Efficacy
•Complete metabolic response (CMR) at end of treatment (EoT) at the selected phase 3 dose is high (88%)
•Achievement of minimal residual disease (MRD) negativity at EoT by PhasED-Seq is an emerging predictor of long-term clinical benefit (progression-free survival [PFS] at 24 months)
•EoT MRD negativity was achieved in 93% (14/15) of patients ctDNA responses exceed published RCHOP and Pola/RCHP ctDNA benchmark criteria

Principaux critères d’éligibilité

• DLBCL (dont haut risque, B riche en T, EBV+)
• 18-80 ans
• IPI ≥3 ou IPI 1 ou 2 avec LDH> 1.3xULN et/ou masse ≥ 7cm
• PS 0-2 (3 si lié à la maladie)
• Ann-Arbor II-IV
• Neutrophiles ≥ 1G/L (0.5 si BM+), Hb ≥ 75g/L, plaquettes ≥ 75G/L (50 si BM+)
• ASAT/ALAT≤2.5xULN, bili≤1.5xULN
• ClCr≥30ml/min

Principaux critères d’inéligibilité

• PMBL, leg-type, LFgr3b (et autres indolents transformés)
• LVEF < 45%
• cancer < 3 ans (sauf localisés)
• refus d’anticoagulation