Firm Announcement
- Based mostly on the topline outcomes from the EPCORE™ NHL-1 medical trial, Genmab and AbbVie will interact international regulatory authorities to debate subsequent steps
- Information from the medical trial to be introduced at a future medical assembly
- Massive B-cell lymphoma (LBCL) is a standard type of non-Hodgkin’s lymphoma (NHL) and presently has restricted therapy choices
Genmab A/S (Nasdaq: GMAB) and ABBVie (NYSE: ABBV) introduced right now topline outcomes from the primary cohort of the EPCORE™ NHL-1 section 1/2, medical trial evaluating epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous bispecific antibody. The research cohort contains 157 sufferers with relapsed/refractory giant B-cell lymphoma (LBCL) who acquired a minimum of two prior traces of systemic remedy, together with 38.9 % who acquired prior therapy with chimeric antigen receptor (CAR) T-cell remedy. Based mostly on the topline outcomes, the businesses will interact international regulatory authorities to find out subsequent steps.
The topline outcomes from this cohort demonstrated an general response fee (ORR) of 63.1 % as confirmed by an impartial assessment committee (IRC), which exceeded the protocol prespecified threshold for efficacy. The noticed median period of response (DOR) was 12 months. The commonest treatment-emergent hostile occasion was cytokine launch syndrome (CRS) with 49.7 %, together with 2.5 % grade 3. The info will likely be submitted for presentation at a future medical assembly.
Epcoritamab is being co-developed by Genmab and AbbVie as a part of the businesses’ broad oncology collaboration. The businesses stay dedicated to evaluating epcoritamab as a monotherapy, and together, throughout traces of remedy, for a wide range of hematologic malignancies, together with an ongoing section 3, open-label, randomized trial evaluating epcoritamab as a monotherapy in sufferers with relapsed/refractory diffuse giant B-cell lymphoma (DLBCL) ( NCT: 04628494 ).
“Along with our accomplice, AbbVie, we’ll work with regulatory authorities to find out subsequent steps and proceed to guage epcoritamab in a wide range of medical trials as a possible therapy choice for sufferers with varied hematological malignancies,” mentioned Jan van de Winkel, Ph.D., Chief Govt Officer of Genmab. “We look ahead to sharing the findings at a future medical assembly.”
LBCL is a fast-growing kind of non-Hodgkin’s lymphoma (NHL) – a most cancers that develops within the lymphatic system – that impacts B-cell lymphocytes, a kind of white blood cell. There are an estimated 150,000 new LBCL instances annually globally. LBCL contains DLBCL, which is the most typical kind of NHL worldwide and accounts for about 31 % of all NHL instances. 1,2,3,4
“We goal to leverage AbbVie’s robust blood most cancers experience to additional develop epcoritamab, alongside Genmab, for sure blood most cancers sufferers who’ve restricted therapy choices,” mentioned Mohamed Zaki, M.D., Ph.D., Vice President and Head, International Oncology Improvement, AbbVie.
In regards to the EPCORE™ NHL-1 Trial
EPCORE™ NHL-1 an open-label, multi-center security and preliminary efficacy trial of epcoritamab that consists of two components: a section 1 first-in-human, dose escalation half; and a section 2 enlargement half. The trial was designed to guage subcutaneous epcoritamab in sufferers with relapsed, progressive or refractory CD20+ mature B-NHL, together with LBCL and DLBCL. The dose escalation findings, which decided the really helpful section 2 dose RP2D, had been printed in The Lancet in 2021. Within the section 2 enlargement half, extra sufferers are being handled with epcoritamab to additional discover the security and efficacy of epcoritamab in three cohorts of sufferers with several types of relapsed/refractory B-NHLs who had restricted therapeutic choices.
The first endpoint of the enlargement half was ORR as assessed by an IRC. Secondary efficacy endpoints included DOR, full response fee, period of full response, progression-free survival, and time to response as decided by the Lugano standards. General survival, time to subsequent remedy, and fee of minimal residual illness negativity had been evaluated as secondary efficacy endpoints.
About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created utilizing Genmab’s proprietary DuoBody know-how. Genmab’s DuoBody-CD3 know-how is designed to direct cytotoxic T cells selectively to tumors to elicit an immune response in the direction of malignant cells. Epcoritamab is designed to concurrently bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of lymphoma B cells. 5 CD20 is a clinically validated therapeutic goal, and is expressed on many B-cell malignancies, together with diffuse giant B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and power lymphocytic leukemia. 6,7 Epcoritamab is being co-developed by Genmab and AbbVie as a part of the businesses’ broad oncology collaboration.
About Genmab
Genmab is a global biotechnology firm with a core function to enhance the lives of individuals with most cancers. For greater than 20 years, Genmab’s imaginative and prescient to rework most cancers therapy has pushed its passionate, revolutionary and collaborative groups to invent next-generation antibody know-how platforms and leverage translational analysis and information sciences, fueling a number of differentiated most cancers remedies that make an impression on folks’s lives. To develop and ship novel therapies to sufferers, Genmab has shaped 20+ strategic partnerships with biotechnology and pharmaceutical corporations. Genmab’s proprietary pipeline contains bispecific T-cell engagers, next-generation immune checkpoint modulators, effector perform enhanced antibodies and antibody-drug conjugates.
Genmab is headquartered in Copenhagen, Denmark with places in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For extra info, please go to Genmab.com and observe us on Twitter.com/Genmab .
About AbbVie
AbbVie’s mission is to find and ship revolutionary medicines that remedy severe well being points right now and deal with the medical challenges of tomorrow. We try to have a outstanding impression on folks’s lives throughout a number of key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, girls’s well being and gastroenterology, along with services throughout its Allergan Aesthetics portfolio. For extra details about AbbVie, please go to us at www.abbvie.com . Comply with @abbvie on Twitter , Fb , Instagram , YouTube and LinkedIn .
Genmab Ahead-Wanting Statements
This Firm Announcement accommodates ahead trying statements. The phrases “consider”, “count on”, “anticipate”, “intend” and “plan” and related expressions determine ahead trying statements. Precise outcomes or efficiency could differ materially from any future outcomes or efficiency expressed or implied by such statements. The essential components that would trigger our precise outcomes or efficiency to vary materially embrace, amongst others, dangers related to pre-clinical and medical improvement of merchandise, uncertainties associated to the result and conduct of medical trials together with unexpected issues of safety, uncertainties associated to product manufacturing, the dearth of market acceptance of our merchandise, our incapability to handle progress, the aggressive surroundings in relation to our enterprise space and markets, our incapability to draw and retain suitably certified personnel, the unenforceability or lack of safety of our patents and proprietary rights, {our relationships} with affiliated entities, adjustments and developments in know-how which can render our merchandise or applied sciences out of date, and different components. For an additional dialogue of those dangers, please seek advice from the chance administration sections in Genmab’s most up-to-date monetary stories, which can be found on www.genmab.com and the chance components included in Genmab’s most up-to-date Annual Report on Kind 20-F and different filings with the U.S. Securities and Trade Fee (SEC), which can be found at www.sec.gov . Genmab doesn’t undertake any obligation to replace or revise ahead trying statements on this Firm Announcement nor to verify such statements to replicate subsequent occasions or circumstances after the date made or in relation to precise outcomes, until required by legislation.
Genmab A/S and/or its subsidiaries personal the next emblems: Genmab ® ; the Y-shaped Genmab brand ® ; Genmab together with the Y-shaped Genmab brand ® ; HuMax ® ; DuoBody ® ; DuoBody together with the DuoBody brand ® ; HexaBody ® ; HexaBody together with the HexaBody brand ® ; DuoHexaBody ® and HexElect ® .
AbbVie Ahead-Wanting Statements
Some statements on this information launch are, or could also be thought of, forward-looking statements for functions of the Non-public Securities Litigation Reform Act of 1995. The phrases “consider,” “count on,” “anticipate,” “venture” and related expressions, amongst others, typically determine forward-looking statements. AbbVie cautions that these forward-looking statements are topic to dangers and uncertainties which will trigger precise outcomes to vary materially from these indicated within the forward-looking statements. Such dangers and uncertainties embrace, however usually are not restricted to, failure to appreciate the anticipated advantages from AbbVie’s acquisition of Allergan plc (“Allergan”), failure to promptly and successfully combine Allergan’s companies, competitors from different merchandise, challenges to mental property, difficulties inherent within the analysis and improvement course of, hostile litigation or authorities motion, adjustments to legal guidelines and laws relevant to our business and the impression of public well being outbreaks, epidemics or pandemics, comparable to COVID-19. Extra details about the financial, aggressive, governmental, technological and different components which will have an effect on AbbVie’s operations is about forth in Merchandise 1A, “Threat Elements,” of AbbVie’s 2021 Annual Report on Kind 10-Okay, which has been filed with the Securities and Trade Fee, as up to date by its subsequent Quarterly Reviews on Kind 10-Q. AbbVie undertakes no obligation to launch publicly any revisions to forward-looking statements on account of subsequent occasions or developments, besides as required by legislation.
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