Genmab Announces Johnson & Johnson Decision Regarding HexaBody®-CD38

Core Viewpoint - Johnson & Johnson (J&J) has opted not to exercise its option for a worldwide license to develop, manufacture, and commercialize HexaBody-CD38, leading Genmab to halt further clinical development of the drug despite promising initial clinical data [1][2][8]. Group 1: Clinical Data and Development - Initial clinical data for HexaBody-CD38 showed robust efficacy, with an overall response rate (ORR) of 55% in the intravenous arm compared to 52% in the subcutaneous daratumumab arm [4]. - The Phase 2 expansion study assessed the objective response rate as the primary endpoint, comparing HexaBody-CD38 with daratumumab in patients with relapsed or refractory multiple myeloma [3][9]. - Treatment emergent adverse events (TEAEs) above 20% in the HexaBody-CD38 arm included neutropenia, infusion-related reactions, anemia, and thrombocytopenia, with no new safety findings in the daratumumab arm [5]. Group 2: Future Focus and Pipeline - Genmab remains confident in its existing pipeline, which includes EPKINLY (epcoritamab) and two wholly owned assets, rinatabart sesutecan (Rina-S™) and acasunlimab, both in Phase 3 development [2]. - The company intends to maintain a disciplined investment strategy focused on its promising late-stage proprietary clinical pipeline to ensure future growth [2]. Group 3: Financial Guidance and Communication - The decision by J&J does not impact Genmab's financial guidance for 2025 [6]. - Genmab will host a conference call to discuss the event, providing an opportunity for stakeholders to gain further insights [7].