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
