Denmark-based Genmab A/S (NASDAQ: GMAB) announced that US giant Johnson & Johnson (J&J, NYSE: JNJ) has decided not to exercise its option to obtain a worldwide license for the development, manufacturing, and commercialization of HexaBody-CD38 (GEN3014). Consequently, clinical development of the drug will be terminated. The decision was based on clinical data, market landscape assessments, and Genmab’s rigorous portfolio prioritization, despite promising initial clinical efficacy.
Clinical Data Overview
Genmab provided J&J with data from a clinical proof-of-concept study in multiple myeloma, as per their development and option agreement. The study included a head-to-head comparison with Darzalex Faspro (daratumumab and hyaluronidase fihj). Preliminary data covered 88 patients who received study treatment, with 84 evaluable for response (42 in each arm).
Efficacy Results
The overall response rate (ORR) was 55% (95% CI: 39%, 70%) in the HexaBody-CD38 IV arm versus 52% in the daratumumab SC arm (95% CI: 36%, 68%). The very good partial response (VGPR) or better rate was 29% versus 17%, and the complete response (CR) or better rate was 7% versus 2%. Secondary efficacy endpoints, including duration of response, progression-free survival, and overall survival, were not yet mature due to the relatively short follow-up time. Follow-up is ongoing, and more mature data will be presented at a future medical conference, according to Genmab.-Fineline Info & Tech
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