Genmab Announces Johnson & Johnson Decision Regarding HexaBody®-CD38
Genmab (Nasdaq: GMAB) announced that Johnson & Johnson (J&J) has declined to exercise its option for a worldwide license to develop, manufacture, and commercialize HexaBody-CD38. Following this decision and a portfolio evaluation, Genmab will discontinue further clinical development of the drug.
The Phase 2 expansion study comparing HexaBody-CD38 with DARZALEX FASPRO® in multiple myeloma patients showed an overall response rate (ORR) of 55% for HexaBody-CD38 versus 52% for daratumumab. Very good partial response rates were 29% vs. 17%, and complete response rates were 7% vs. 2%. Common treatment emergent adverse events included neutropenia, infusion-related reactions, anemia, and thrombocytopenia.
Despite promising clinical data validating the HexaBody platform's potential, Genmab will focus on its existing pipeline, including EPKINLY® and two wholly owned assets in Phase 3 development: rinatabart sesutecan and acasunlimab. The company maintains its 2025 Financial Guidance.
Genmab (Nasdaq: GMAB) ha annunciato che Johnson & Johnson (J&J) ha deciso di non esercitare la propria opzione per una licenza mondiale per sviluppare, produrre e commercializzare HexaBody-CD38. A seguito di questa decisione e di una valutazione del portafoglio, Genmab interromperà ulteriori sviluppi clinici del farmaco.
Lo studio di espansione di Fase 2 che confrontava HexaBody-CD38 con DARZALEX FASPRO® in pazienti con mieloma multiplo ha mostrato un tasso di risposta globale (ORR) del 55% per HexaBody-CD38 rispetto al 52% per daratumumab. I tassi di risposta parziale molto buoni erano del 29% contro il 17%, e i tassi di risposta completa erano del 7% contro il 2%. Gli eventi avversi emergenti comuni includevano neutropenia, reazioni correlate all'infusione, anemia e trombocitopenia.
Nonostante i dati clinici promettenti che convalidano il potenziale della piattaforma HexaBody, Genmab si concentrerà sul proprio portafoglio esistente, inclusi EPKINLY® e due asset interamente posseduti in sviluppo di Fase 3: rinatabart sesutecan e acasunlimab. L'azienda mantiene la sua guida finanziaria per il 2025.
Genmab (Nasdaq: GMAB) anunció que Johnson & Johnson (J&J) ha decidido no ejercer su opción para una licencia mundial para desarrollar, fabricar y comercializar HexaBody-CD38. Tras esta decisión y una evaluación de su cartera, Genmab interrumpirá el desarrollo clínico adicional del fármaco.
El estudio de expansión de Fase 2 que compara HexaBody-CD38 con DARZALEX FASPRO® en pacientes con mieloma múltiple mostró una tasa de respuesta global (ORR) del 55% para HexaBody-CD38 frente al 52% para daratumumab. Las tasas de respuesta parcial muy buena fueron del 29% frente al 17%, y las tasas de respuesta completa fueron del 7% frente al 2%. Los eventos adversos emergentes comunes incluyeron neutropenia, reacciones relacionadas con la infusión, anemia y trombocitopenia.
A pesar de los prometedores datos clínicos que validan el potencial de la plataforma HexaBody, Genmab se centrará en su cartera existente, incluyendo EPKINLY® y dos activos de propiedad total en desarrollo de Fase 3: rinatabart sesutecan y acasunlimab. La empresa mantiene su guía financiera para 2025.
Genmab (Nasdaq: GMAB)는 Johnson & Johnson (J&J)이 HexaBody-CD38의 개발, 제조 및 상업화를 위한 전 세계 라이센스를 행사하지 않기로 결정했다고 발표했습니다. 이 결정과 포트폴리오 평가에 따라 Genmab는 해당 약물의 추가 임상 개발을 중단할 것입니다.
다양한 다발성 골수종 환자에서 HexaBody-CD38과 DARZALEX FASPRO®를 비교한 2상 확장 연구에서 HexaBody-CD38의 전체 반응률(ORR)은 55%로, daratumumab의 52%와 비교되었습니다. 매우 좋은 부분 반응률은 29% 대 17%, 완전 반응률은 7% 대 2%였습니다. 일반적인 치료 유발 부작용으로는 호중구감소증, 주입 관련 반응, 빈혈 및 혈소판감소증이 포함되었습니다.
HexaBody 플랫폼의 잠재력을 검증하는 유망한 임상 데이터에도 불구하고, Genmab는 EPKINLY® 및 3상 개발 중인 두 개의 전액 소유 자산인 rinatabart sesutecan과 acasunlimab을 포함한 기존 파이프라인에 집중할 것입니다. 회사는 2025년 재무 가이드를 유지합니다.
Genmab (Nasdaq: GMAB) a annoncé que Johnson & Johnson (J&J) a décidé de ne pas exercer son option pour une licence mondiale afin de développer, fabriquer et commercialiser HexaBody-CD38. Suite à cette décision et à une évaluation de portefeuille, Genmab mettra fin au développement clinique supplémentaire du médicament.
L'étude d'expansion de phase 2 comparant HexaBody-CD38 à DARZALEX FASPRO® chez des patients atteints de myélome multiple a montré un taux de réponse global (ORR) de 55% pour HexaBody-CD38 contre 52% pour daratumumab. Les taux de réponse partielle très bonne étaient de 29 % contre 17 %, et les taux de réponse complète étaient de 7 % contre 2 %. Les événements indésirables émergents courants comprenaient la neutropénie, les réactions liées à l'infusion, l'anémie et la thrombocytopénie.
Malgré des données cliniques prometteuses validant le potentiel de la plateforme HexaBody, Genmab se concentrera sur son pipeline existant, y compris EPKINLY® et deux actifs entièrement détenus en développement de phase 3 : rinatabart sesutecan et acasunlimab. L'entreprise maintient ses prévisions financières pour 2025.
Genmab (Nasdaq: GMAB) gab bekannt, dass Johnson & Johnson (J&J) beschlossen hat, seine Option für eine weltweite Lizenz zur Entwicklung, Herstellung und Vermarktung von HexaBody-CD38 nicht auszuüben. Nach dieser Entscheidung und einer Portfolio-Bewertung wird Genmab die klinische Entwicklung des Medikaments einstellen.
Die Erweiterungsstudie der Phase 2, die HexaBody-CD38 mit DARZALEX FASPRO® bei Patienten mit multiplem Myelom verglich, zeigte eine Gesamtansprechrate (ORR) von 55% für HexaBody-CD38 im Vergleich zu 52% für Daratumumab. Die sehr guten partiellen Ansprechquoten lagen bei 29% gegenüber 17%, und die vollständigen Ansprechquoten bei 7% gegenüber 2%. Häufige behandlungsbedingte unerwünschte Ereignisse umfassten Neutropenie, infusionbedingte Reaktionen, Anämie und Thrombozytopenie.
Trotz vielversprechender klinischer Daten, die das Potenzial der HexaBody-Plattform bestätigen, wird sich Genmab auf sein bestehendes Portfolio konzentrieren, einschließlich EPKINLY® und zwei vollständig im Besitz befindlichen Vermögenswerten in der Phase 3-Entwicklung: Rinatabart Sesutecan und Acasunlimab. Das Unternehmen hält an seiner Finanzprognose für 2025 fest.
- Clinical data validated HexaBody platform's potential for future applications
- HexaBody-CD38 showed slightly better efficacy metrics compared to DARZALEX FASPRO
- Strong alternative pipeline with EPKINLY and two Phase 3 assets
- Johnson & Johnson declined worldwide license option for HexaBody-CD38
- Genmab discontinuing further clinical development of HexaBody-CD38
- Loss of potential future revenue stream from HexaBody-CD38 commercialization
Insights
Johnson & Johnson's decision to pass on licensing Genmab's HexaBody-CD38 represents a significant setback for Genmab's pipeline. Despite Genmab reporting that HexaBody-CD38 showed promising Phase 2 data with
The discontinuation eliminates a potential revenue stream from milestone payments and royalties that would have materialized had J&J exercised its option. This also removes a complementary product to DARZALEX from Genmab's multiple myeloma portfolio.
Management's decision to frame this as validation of the HexaBody platform technology while simultaneously discontinuing the program sends mixed signals. The preliminary efficacy data showed only modest improvements over the established DARZALEX, suggesting the differentiation might not have been compelling enough for commercial success.
Genmab is now emphasizing its focus on EPKINLY (epcoritamab) and two wholly-owned Phase 3 assets - rinatabart sesutecan and acasunlimab. This narrower pipeline focus may allow for more efficient capital allocation but increases the importance of success for these remaining late-stage programs.
While management confirmed this decision won't impact their 2025 financial guidance, suggesting near-term financial implications, the long-term impact depends on whether other HexaBody platform candidates can demonstrate more compelling differentiation in the future.
This pipeline setback highlights the extremely high bar for success in the competitive multiple myeloma market. The comparative data between HexaBody-CD38 and DARZALEX FASPRO revealed only incremental benefits in efficacy (
J&J's decision to pass on the license option reflects a calculated commercial assessment. Even with slightly improved efficacy metrics, the challenges of market penetration against established therapies (including J&J's own DARZALEX) likely factored into this decision. The similar safety profile, featuring neutropenia, infusion reactions, anemia, and thrombocytopenia, offered no meaningful differentiation.
Genmab's subsequent decision to discontinue development rather than pursue it independently speaks volumes about the commercial realities they face. Without J&J's commercial infrastructure and existing presence in multiple myeloma, Genmab likely concluded the development costs couldn't be justified by the potential market opportunity.
This reprioritization aligns with the industry trend toward more disciplined capital allocation. By concentrating resources on their most promising assets, particularly wholly-owned programs like rinatabart sesutecan and acasunlimab where they retain full economics, Genmab may ultimately create more shareholder value despite this setback.
The announcement's timing and Genmab's reaffirmation of 2025 guidance suggests this outcome was contemplated in their financial planning, though it does raise questions about the longer-term revenue growth trajectory beyond current projections.
- Johnson & Johnson has decided that it will not exercise its option to receive a worldwide license to develop, manufacture and commercialize HexaBody-CD38
- Genmab will not pursue further clinical development of HexaBody-CD38
- Data validates clinical potential of the HexaBody platform
- Genmab to host a conference call today at 5:00 PM CET / 4:00 PM GMT / 12:00 PM EDT
“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
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
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: https://genmab-investor-update-mar2025.open-exchange.net/.
An archived webcast of the call will be available at https://www.genmab.com/investor-relations.
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 https://www.clinicaltrials.gov (NCT04824794).
About Genmab
Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For more than 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO) antibody medicines®.
Established in 1999, Genmab is headquartered in
This Company Announcement contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the
Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO®. DARZALEX FASPRO® is a trademark of Johnson & Johnson. EPKINLY® and its design is a trademark of AbbVie Biotechnology Ltd. Rina-S™ is a trademark of ProfoundBio, US Co. and ProfoundBio (
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FAQ
What were the clinical results of HexaBody-CD38 compared to DARZALEX FASPRO in the Phase 2 trial?
Why did Johnson & Johnson decline to license Genmab's HexaBody-CD38?
What are the main side effects reported in the HexaBody-CD38 trial for GMAB?
How does this decision affect Genmab's (GMAB) 2025 Financial Guidance?
What alternative pipeline assets is GMAB focusing on after discontinuing HexaBody-CD38?
