On March 10, 2025 Genmab A/S (Nasdaq: GMAB) reported that Johnson & Johnson (J&J) has decided that it will not exercise its option to receive a worldwide license to develop, manufacture and commercialize HexaBody-CD38 (GEN3014) (Press release, Genmab, MAR 10, 2025, View Source [SID1234651040]). While the initial HexaBody-CD38 clinical data is promising and showed robust clinical efficacy, following a thorough evaluation of the data, the market landscape, and Genmab’s rigorous portfolio prioritization, Genmab will not pursue further clinical development of HexaBody-CD38.
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"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. "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. 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."
As stipulated by the development and option agreement between Genmab and J&J for HexaBody-CD38, Genmab provided J&J with data from a clinical proof-of-concept study in multiple myeloma, including a head-to-head comparison with DARZALEX FASPRO (daratumumab and hyaluronidase fihj).
The Phase 2 expansion Part B of the study assessed the objective response rate (primary endpoint) of intravenous HexaBody-CD38 versus subcutaneous daratumumab in patients with anti-CD38 antibody- naïve relapsed or refractory multiple myeloma.
Preliminary data submitted by Genmab to J&J, inclusive of 88 patients who received a study treatment and 84 patients who were response evaluable (42 in each arm), demonstrated an overall response rate (ORR) of 55% (95% CI: 39%, 70%) in the HexaBoby-CD38 IV arm vs. 52% in the daratumumab SC arm (95% CI: 36%, 68%); very good partial response (VGPR) or better rate was 29% vs. 17%; and complete response (CR) or better rate was 7% vs. 2%.
Due to the relatively short follow-up time, secondary efficacy endpoints including duration of response, progression-free survival, and overall survival were not mature yet. Treatment emergent Adverse events (TEAEs) above 20% in the Hexabody-CD38 arm were neutropenia, infusion related reactions, anemia, and thrombocytopenia. No new safety findings were observed in the daratumumab arm of the study. TEAEs leading to death included one patient in the HexaBody-CD38 IV arm and two patients in the daratumumab SC arm; none of these deaths was related to the study treatment. Follow-up is ongoing and more mature data will be presented at a future medical conference.
This news does not impact Genmab’s 2025 Financial Guidance.
Conference Call Details
Genmab will host a conference call to discuss this event today at 5:00 PM CET / 4:00 PM GMT / 12:00 PM EDT. To join the call or listen to the webcast, please register using the following link: View Source
An archived webcast of the call will be available at View Source
About the 3014-01 Trial
3014-01 is a Phase 1/2, open-label, multi-center trial to evaluate the safety and preliminary efficacy of HexaBody-CD38 as a monotherapy in patients with relapsed or refractory multiple myeloma and other blood cancers. The trial consists of three parts: a dose-escalation phase (Phase 1) and an expansion phase (Part A and Part B). The primary objective of Phase 1 is to determine the recommended Phase 2 dose and the maximum tolerated dose as well as establish the safety profile of HexaBody-CD38 monotherapy. The purpose of Phase 2 Expansion Part A is to assess the objective response rate of HexaBody-CD38 for patients with relapsed or refractory multiple myeloma and other blood cancers. The purpose of Phase 2 Expansion Part B is to assess the objective response rate of HexaBody-CD38 versus subcutaneous daratumumab in patients with CD38 antibody naïve relapsed or refractory multiple myeloma. More information on this trial can be found at View Source (NCT04824794).