Genmab (NASDAQ:GMAB) announced today that Johnson & Johnson (NYSE:JNJ) has opted not to exercise its option for a worldwide license to develop and commercialize HexaBody-CD38 (GEN3014).
This decision follows a thorough evaluation of clinical data, the current market landscape, and Genmab's internal portfolio priorities.
While initial Phase 2 clinical data demonstrated promising efficacy, including a head-to-head comparison with J&J’s own DARZALEX FASPRO (daratumumab and hyaluronidase fihj) in multiple myeloma, Genmab has decided to discontinue further clinical development of HexaBody-CD38.
The Phase 2 study, which compared intravenous HexaBody-CD38 to subcutaneous daratumumab in patients with anti-CD38 antibody-naive relapsed or refractory multiple myeloma, revealed an overall response rate (ORR) of 55% in the HexaBody-CD38 arm versus 52% in the daratumumab arm.
Additionally, the HexaBody-CD38 arm showed a very good partial response (VGPR) or better rate of 29% compared to 17% for daratumumab, and a complete response (CR) or better rate of 7% versus 2%.
Due to the relatively short follow-up period, secondary efficacy endpoints such as duration of response, progression-free survival, and overall survival remain immature.
Genmab will now focus its resources on its advanced pipeline, including EPKINLY® (epcoritamab), rinatabart sesutecan (Rina-S™), and acasunlimab, both of which are in Phase 3 development.
The company remains confident in its existing pipeline and will continue to execute its capital allocation framework to ensure future growth.