Fianlimab fianlimab PHASE3
Drug Profile
ModalityMonoclonal antibody
RouteIV
Therapy AreaOncology
Peak Sales Est$4000M
Formulations[]
Companies
REGN (ORIGINATOR)100%
Mechanism: LAG-3 inhibitor (monoclonal antibody)
Expert: Fully human IgG4 monoclonal antibody targeting lymphocyte-activation gene 3 (LAG-3). Blocks LAG-3 interaction with MHC-II on tumor/APC cells, reversing T-cell exhaustion. Used in combination with anti-PD-1 (cemiplimab) for dual checkpoint blockade.
Everyday: Blocks LAG-3, a "brake pedal" on T-cells that tumors exploit to hide from the immune system. Removing this brake (on top of removing PD-1 brake) gives T-cells a double boost to attack cancer.
Targets: ["LAG-3"]
Programs (2)
IndicationStageKey StudyRegional Status
Adjuvant melanomaPHASE3RELATIVITY-106[]
Metastatic melanoma 1LPHASE3RELATIVITY-104[]
Upcoming Catalysts (2)
Fianlimab - Metastatic Melanoma 1L - Ph3 Topline (RELATIVITY-104) 2026
Fianlimab - Adjuvant Melanoma - Ph3 Topline (RELATIVITY-106) H2 2026
Notes
LAG-3 inhibitor combined with Libtayo (cemiplimab, PD-1). Dual checkpoint blockade for melanoma. RELATIVITY-106 (adjuvant) and RELATIVITY-104 (metastatic 1L) are the pivotal Ph3s. Competes with nivo+rela (BMS Opdualag). If both trials positive, could establish REGN as a melanoma leader. High-conviction pipeline asset for REGN.
Data from Supabase · Updated 2026-03-24