Shots:

• The EMA has validated the MAA for epcoritamab to treat adult patients with r/r DLBCL after ≥2 lines of systemic therapy. Epcoritamab is being co-developed by AbbVie & Genmab
• The submission was based on the LBCL cohort of the P-II (EPCORE NHL-1) trial evaluating the safety & preliminary efficacy of epcoritamab in adult patients with r/r CD20+ mature B-cell NHL incl. DLBCL. The trial includes a P-I first-in-human, dose escalation part; a P-II expansion part; and an optimization part
• The 1EPs of the P-II expansion part was ORR & secondary efficacy EPs incl. DoR, CRR, PFS, OS, time to response, time to next therapy, and rate of MRD negativity. Genmab has submitted BLA to the US FDA for epcoritamab in r/r LBCL

Ref: PRNewswire | Image: AbbVie