Genmab A/S announced today that Johnson & Johnson (J&J) has decided not to exercise its option to obtain worldwide license rights for HexaBody-CD38 (GEN3014), an investigational antibody therapeutic for multiple myeloma. Despite promising clinical data, Genmab also stated it will not pursue further development of the compound following a thorough evaluation of the market landscape and portfolio priorities.
"While we are disappointed that J&J has decided not to advance HexaBody-CD38, the data confirms the clinical potential of the HexaBody platform, reinforcing its value for future applications," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
The decision follows a head-to-head clinical proof-of-concept study comparing HexaBody-CD38 with DARZALEX FASPRO® (daratumumab and hyaluronidase fihj) in patients with relapsed or refractory multiple myeloma who were naïve to anti-CD38 antibody treatment.
Clinical Trial Results Show Promising Efficacy
Preliminary data from the Phase 2 expansion Part B of the study included 88 patients who received treatment, with 84 patients evaluable for response (42 in each treatment arm). The results demonstrated:
- Overall response rate (ORR): 55% (95% CI: 39%, 70%) for HexaBody-CD38 IV versus 52% (95% CI: 36%, 68%) for daratumumab SC
- Very good partial response (VGPR) or better: 29% for HexaBody-CD38 versus 17% for daratumumab
- Complete response (CR) or better: 7% for HexaBody-CD38 versus 2% for daratumumab
Due to the relatively short follow-up period, secondary endpoints including duration of response, progression-free survival, and overall survival were not yet mature.
Safety Profile
The most common treatment-emergent adverse events (occurring in >20% of patients) in the HexaBody-CD38 arm included:
- Neutropenia
- Infusion-related reactions
- Anemia
- Thrombocytopenia
Treatment-emergent adverse events leading to death occurred in one patient in the HexaBody-CD38 IV arm and two patients in the daratumumab SC arm, though none were determined to be related to the study treatment.
Strategic Focus on Late-Stage Pipeline
Despite the promising clinical data for HexaBody-CD38, Genmab has decided to focus its resources on other pipeline assets.
"With EPKINLY® (epcoritamab) moving from strength to strength and two wholly owned assets, rinatabart sesutecan (Rina-S™) and acasunlimab in Phase 3 development, we are confident in the potential of our existing pipeline of innovative antibody therapeutics," van de Winkel explained. "Genmab intends to maintain its laser sharp focus on and disciplined investments in our promising late-stage proprietary clinical pipeline and continues to execute against our capital allocation framework ensuring future growth."
About the Clinical Trial
The 3014-01 trial was a Phase 1/2, open-label, multi-center study evaluating HexaBody-CD38 as monotherapy in patients with relapsed or refractory multiple myeloma and other blood cancers. The trial consisted of three parts: a dose-escalation phase (Phase 1) and an expansion phase (Parts A and B).
The primary objective of Phase 2 Expansion Part B was to assess the objective response rate of HexaBody-CD38 versus subcutaneous daratumumab in patients with CD38 antibody-naïve relapsed or refractory multiple myeloma.
Market Impact
Genmab stated that this development does not impact its 2025 Financial Guidance. The company plans to present more mature data from the study at a future medical conference.
The decision highlights the increasingly competitive landscape in multiple myeloma treatment, where several therapeutic options already exist, including J&J's own DARZALEX franchise. For Genmab, the focus now shifts to advancing its other late-stage assets and leveraging its antibody technology platforms for future applications.
Founded in 1999 and headquartered in Copenhagen, Denmark, Genmab continues to focus on its vision to transform the lives of people with cancer and other serious diseases through innovative antibody medicines by 2030.
