RegulationPriority Review (US), Breakthrough Therapy (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Orphan Drug (AU), Conditional marketing approval (EU)

Gene Sequence

Sequence Code 143818L

Source: *****

Sequence Code 319323760L

Source: *****

Sequence Code 319323796H

Source: *****

Sequence Code 616714422H

Source: *****

Clinical Trials associated with Epcoritamab

NCT06563596 / Not yet recruitingPhase 2IIT

A Phase 2 Study of Epcoritamab, Zanubrutinib, and Rituximab (EZR) for Treatment of Relapsed or Refractory Follicular Lymphoma

The purpose of this study is to determine how effective and safe the combination of epcoritamab, zanubrutinib, and rituximab is in treating participants with relapse or refractory Follicular Lymphoma (FL).
* The names of the study drugs involved in this research study are:
* Epcoritamab (a type of antibody)
* Zanubrutinib (a type of Bruton tyrosine kinase inhibitor)
* Rituximab (a type of monoclonal antibody)

Start Date01 Feb 2025

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+2]

NCT06510361 / Not yet recruitingPhase 2IIT

A Phase 2 Study of Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a Complete Response With Upfront Chemoimmunotherapy

This research is being done to see if epcoritamab is effective in treating follicular lymphoma as a second line of treatment.
The name of the study drug in this research study is:
-Epcoritamab (a type of antibody)

Start Date01 Dec 2024

Sponsor / Collaborator

Beth Israel Deaconess Medical Center, Inc.

[+1]

NCT06575686 / Not yet recruitingPhase 2

A Phase 2 Study of Epcoritamab Plus Tazemetostat for Treatment of Relapsed/Refractory Follicular Lymphoma

This phase II trial tests the safety, side effects and effectiveness of epcoritamab and tazemetostat in treating patients with grade I-IIIa follicular lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Epcoritamab is a bispecific monoclonal antibody that binds to two different antigens on the surface of cancer cells that may help the body's immune system attack the cancer and may interfere with the ability of the cancer cells to grow and spread. Tazemetostat, a EZH2 inhibitor, may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving epcoritamab and tazemetostat may be safe, tolerable and/or effective in treating patients with relapsed or refractory grade I-IIIa follicular lymphoma.

Start Date23 Nov 2024

Sponsor / Collaborator

Hope Medical Center

[+1]

100 Clinical Results associated with Epcoritamab

100 Translational Medicine associated with Epcoritamab

100 Patents (Medical) associated with Epcoritamab

Literatures (Medical) associated with Epcoritamab

31 Dec 2024·mAbs

Antibodies to watch in 2024

Article

Author: Reichert, Janice M ; Kaplon, Hélène ; Crescioli, Silvia ; Wang, Lin ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

31 Dec 2024·mAbs

A pivotal decade for bispecific antibodies?

Article

Author: Surowka, Marlena ; Klein, Christian

Bispecific antibodies (bsAbs) are a class of antibodies that can mediate novel mechanisms of action compared to monospecific monoclonal antibodies (mAbs). Since the discovery of mAbs and their adoption as therapeutic agents in the 1980s and 1990s, the development of bsAbs has held substantial appeal. Nevertheless, only three bsAbs (catumaxomab, blinatumomab, emicizumab) were approved through the end of 2020. However, since then, 11 bsAbs received regulatory agency approvals, of which nine (amivantamab, tebentafusp, mosunetuzumab, cadonilimab, teclistamab, glofitamab, epcoritamab, talquetamab, elranatamab) were approved for the treatment of cancer and two (faricimab, ozoralizumab) in non-oncology indications. Notably, of the 13 currently approved bsAbs, two, emicizumab and faricimab, have achieved blockbuster status, showing the promise of this novel class of therapeutics. In the 2020s, the approval of additional bsAbs can be expected in hematological malignancies, solid tumors and non-oncology indications, establishing bsAbs as essential part of the therapeutic armamentarium.

01 Aug 2024·Lancet Haematology

Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma (EPCORE NHL-1): a phase 2 cohort of a single-arm, multicentre study

Article

Author: Gernhardt, Diana ; Christensen, Jacob Haaber ; Vitolo, Umberto ; Elliott, Brian ; Dinh, Minh H ; Tilly, Hervé ; Liu, Yan ; Gyan, Emmanuel ; Altıntaş, Işıl ; Cochrane, Tara ; Jurczak, Wojciech ; Cordoba, Raul ; Hutchings, Martin ; Chamuleau, Martine E D ; Vose, Julie M ; Lewis, David John ; Sancho, Juan-Manuel ; Thieblemont, Catherine ; Clausen, Michael Roost ; Favaro, Elena ; Sureda, Anna ; Linton, Kim M ; Okada, Craig ; Lugtenburg, Pieternella J ; Ahmadi, Tahamtan ; Leppä, Sirpa ; Hess, Brian ; Hoehn, Daniela

BACKGROUND:

A standard of care and optimal duration of therapy have not been established for patients with multiply relapsed or refractory follicular lymphoma. The aim of this study was to evaluate epcoritamab, a novel CD3 × CD20 bispecific antibody, in the third-line and later setting of follicular lymphoma.

METHODS:

EPCORE NHL-1 is a multicohort, single-arm, phase 1-2 trial conducted at 88 sites across 15 countries. Here, we report the primary analysis of patients with relapsed or refractory follicular lymphoma in the phase 2 part of the trial, which included the pivotal (dose expansion) cohort and the cycle 1 optimisation cohort. Eligible patients were aged 18 years or older, had relapsed or refractory CD20⁺ follicular lymphoma (grade 1-3A), an Eastern Cooperative Oncology Group performance status of up to 2, and had received at least two previous lines of therapy (including an anti-CD20 monoclonal antibody and an alkylating agent or lenalidomide). Patients were treated with subcutaneous epcoritamab 48 mg in 28-day cycles: weekly in cycles 1-3, biweekly in cycles 4-9, and every 4 weeks until disease progression or unacceptable toxicity. To mitigate the risk and severity of cytokine release syndrome, in the pivotal cohort, cycle 1 consisted of a step-up dosing regimen of a 0·16-mg priming dose on day 1 and a 0·80-mg intermediate dose on day 8, followed by subsequent 48-mg full doses and prophylactic prednisolone 100 mg; in the cycle 1 optimisation cohort, a second intermediate dose of 3 mg on day 15, adequate hydration, and prophylactic dexamethasone 15 mg were evaluated during cycle 1 to further reduce risk and severity of cytokine release syndrome. Primary endpoints were independently reviewed overall response rate for the pivotal cohort and the proportion of patients with grade 2 or worse and any-grade cytokine release syndrome for the cycle 1 optimisation cohort. Analyses were done in all enrolled patients who had received at least one dose of epcoritamab. This study is registered with ClinicalTrials.gov, NCT03625037, and is ongoing.

FINDINGS:

Between June 19, 2020, and April 21, 2023, 128 patients (median age 65 years [IQR 55-72]; 49 [38%] female and 79 [62%] male) were enrolled and treated in the pivotal cohort (median follow-up 17·4 months [IQR 9·1-20·9]). The overall response rate was 82·0% (105 of 128 patients; 95% CI 74·3-88·3), with a complete response rate of 62·5% (80 of 128; 95% CI 53·5-70·9). The most common grade 3-4 treatment-emergent adverse event was neutropenia in 32 (25%) of 128 patients. Grade 1-2 cytokine release syndrome was reported in 83 (65%) of 128 patients; grade 3 cytokine release syndrome was reported in two (2%). Immune effector cell-associated neurotoxicity syndrome was reported in eight (6%) of 128 patients (five [4%] grade 1; three [2%] grade 2). Between Oct 25, 2022, and Jan 8, 2024, 86 patients (median age 64 years [55-71]; 37 [43%] female and 49 [57%] male) were enrolled and treated in the cycle 1 optimisation cohort. The incidence of cytokine release syndrome was 49% (42 of 86 patients; eight [9%] grade 2; none of grade 3 or worse), with no reported immune effector cell-associated neurotoxicity syndrome.

INTERPRETATION:

Epcoritamab monotherapy showed clinically meaningful activity in patients with multiply relapsed or refractory follicular lymphoma, and had a manageable safety profile.

FUNDING:

Genmab and AbbVie.

128

News (Medical) associated with Epcoritamab

16 Sep 2024

·www.prnewswire.com

Expanding the Bispecific Antibody Market from CAR-Ts to Drive Follicular Lymphoma's Future | DelveInsight

The competition in follicular lymphoma is rapidly intensifying, with three CAR-T therapies and three bispecific antibodies now approved for relapsed or refractory patients. As both classes of treatments expand, the battle for dominance in this market is growing, with each therapy offering unique advantages in accessibility, efficacy, and safety profiles, setting the stage for a dynamic shift in treatment strategies. LAS VEGAS, Sept. 16, 2024 /PRNewswire/ -- Follicular lymphoma is a type of non-Hodgkin lymphoma (NHL) that develops from B-lymphocytes and is generally slow-growing or indolent. This subtype represents 20–30% of all NHL cases. While follicular lymphoma typically progresses slowly, there are instances where it can grow more rapidly. Treatment options for follicular lymphoma include, chemotherapy, radiation therapy, immunotherapy, stem cell transplantation, CAR T-cell therapy, and bispecific-antibodies. For those in the early stages of the disease (Ann Arbor stages I or II), treatment may involve radiation therapy alone or in combination with chemotherapy. Patients with advanced follicular lymphoma are typically treated initially with a combination of chemotherapy and anti-CD20 antibodies, a method known as chemoimmunotherapy. The most commonly used antibodies are RITUXAN (rituximab) and GAZYVA (obinutuzumab), which specifically target tumor cells associated with follicular lymphoma. In older patients who do not have organ dysfunction, treatment with rituximab alone may be an option. Other therapies like ZEVALIN (yttrium-90 ibritumomab tiuxetan), TAZVERIK (tazemetostat), REVLIMID (lenalidomide), and others are approved for the treatment of follicular lymphoma. CAR T-cell therapies are becoming increasingly significant in treating follicular lymphoma. YESCARTA, a CD19-directed genetically modified autologous T-cell therapy, became the first CAR-T to be approved for follicular lymphoma by the US FDA in March 2021. Before the approval of YESCARTA, BREYANZI was approved in February 2021 for Grade 3B follicular lymphoma that accounts for about 5-10% of all follicular lymphoma cases. Later in April 2022 it was approved by the European commission. In May 2024 BREYANZI was approved for the treatment of relapsed/refractory follicular lymphoma who have received two or more prior lines of systemic therapy and provided sustained clinical benefit with median duration of response not reached and the majority (77.1%) of responders in ongoing response at 18 months. In May 2022, Novartis announced that the European Commission approved KYMRIAH (tisagenlecleucel) for adult patients with relapsed/refractory follicular lymphoma who have undergone two or more systemic therapies. This approval represents the third indication for KYMRIAH, making it the first CAR-T cell therapy sanctioned in Europe for such patients, including those with relapsed/refractory follicular lymphoma Grades 1, 2, and 3A. Additionally, in May 2022, the US FDA granted approval for KYMRIAH for the same patient group. Currently, autologous CAR-T therapies are the only ones approved, but the emerging pipeline predominantly comprises autologous CAR-Ts alongside a growing number of allogeneic CAR-T therapies. Allogeneic CAR-T, a newer term, refers to donor-derived therapies offering several advantages over autologous treatments. These off-the-shelf therapies are readily available, eliminating the need to modify patient cells either at a central manufacturing site or at the point of care. Even though the reimbursement of CAR-T therapies represents a challenge for healthcare providers, insurers, and government agencies, they have successfully reached the majority of the markets by considering the patient pool demand. While determining the cost and reimbursement, various factors, such as pharmacoeconomic analysis and outcome-based responses, as well as the added value to society, have been evaluated. The CAR T-cell-related toxicity, such as the cytokine-release syndrome and neurotoxicity, remain important potential complications of this therapy. Second generation CAR T-cell therapies are emerging with more safety and efficacy to overcome these limitations. If these limitations have been overcome, these are going to be the potential drivers of the market. After CAR-T approval companies focused on developing alternative therapies to overcome CAR-Ts limitations. LUNSUMIO became the first bispecific antibody to get approval for adult patients with relapsed/refractory follicular lymphoma who have undergone two or more lines of systemic treatment in June 2022 in Europe. Later in December 2022, the US FDA approved it for the same indication. This was the game changing step toward a brighter future for follicular lymphoma patients. Bispecific antibodies are ready to use therapies and safer treatment options than CAR-Ts. In 2023, LUNSUMIO captured USD 55 million in revenue in the United States for follicular lymphoma. In the United States, AbbVie and Genmab's epcoritamab, marketed as EPKINLY, first gained FDA approval in May 2023 for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This was followed by its approval for follicular lymphoma in June 2024. With the recent FDA authorization for relapsed/refractory follicular lymphoma, along with expected approvals and launches in international markets, EPKINLY is poised to see revenue growth in the coming quarters. Its strong performance in treating relapsed/refractory DLBCL suggests it could achieve similar success in follicular lymphoma. LUNSUMIO now faces competition in the European market for follicular lymphoma, as on August 19, 2024, the European Commission granted approval for the expanded use of AbbVie and Genmab's bispecific antibody, TEPKINLY (epcoritamab), for treating adults with relapsed/refractory follicular lymphoma. The study showed an overall response rate of 83% and a complete response rate of 63%, with the median response duration being 21.4 months. Just after TEPKINLY approval in Europe, Regeneron's ORDSPONO (odronextamab) a CD20 x CD3 bispecific antibody approved by European Commission on August 26, 2024 for the treatment of adult patients with relapsed/refractory follicular lymphoma or relapsed/refractory DLBCL, after two or more lines of systemic therapy. After this approval, ORDSPONO becomes the first off-the-shelf option that can be administered in the out-patient setting. In March 2024, the US FDA declined approval for odronextamab for treating follicular lymphoma and DLBCL. The agency issued two complete response letters concerning the biologics license application (BLA) for odronextamab in relapsed/refractory follicular lymphoma and DLBCL after two or more lines of systemic therapy. The denial was tied to the enrollment status of confirmatory trials assessing the drug. Importantly, there were no concerns raised about odronextamab's efficacy, safety, trial design, labeling, or manufacturing. Both EPKINLY, LUNSUMIO, and ORDSPONO are off-the-shelf therapies, offering greater accessibility compared to CD19 CAR-T treatments. These drugs will compete not only with each other but also with CAR-T therapies to secure a substantial portion of the follicular lymphoma market. Learn more about the FDA-approved follicular lymphoma drugs @ Drugs for Follicular Lymphoma Treatment A new class has also emerged for the treatment of follicular lymphoma, i.e., Bruton tyrosine kinase (BTK) inhibitors. In November 2023, BeiGene received approval from the European Commission for BRUKINSA (zanubrutinib) to treat relapsed/refractory follicular lymphoma. Later in March 2024, the US FDA approved BRUKINSA for the same indication. BRUKINSA is the first and only BTK inhibitor approved for this condition. To know more about follicular lymphoma treatment options, visit @ New Treatment for Follicular Lymphoma The follicular lymphoma pipeline is robust with so many companies working in the domain. Various potential therapies that are projected to enter during the forecast period include AbbVie's IMBRUVICA, Xynomic Pharmaceuticals' Abexinostat, Pfizer PF-06821497, Incyte's Parsaclisib, Bristol-Myers Squibb's Nivolumab, and others. Discover which therapies are expected to grab major follicular lymphoma market share @ Follicular Lymphoma Market Report IMBRUVICA (ibrutinib) is an anti-cancer medication available in various forms, including hard gelatin capsules, tablets, film-coated tablets, and oral suspension. It is being developed by AbbVie and is currently undergoing Phase III trials for follicular lymphoma. This study aims to determine if adding ibrutinib to the treatment will extend progression-free survival (PFS) compared to using rituximab alone in patients with newly diagnosed follicular lymphoma. Xynomic Pharmaceuticals is developing Abexinostat for treating follicular lymphoma. The company is currently testing this investigational drug in a Phase II clinical trial involving patients with relapsed/refractory follicular lymphoma who have received at least three prior therapies. The US FDA has granted Abexinostat fast-track designation for this use. In June 2021, Xynomic completed a short-form merger with Xu-Nuo Pharma in a "Going Private" transaction. Post-merger, Xu-Nuo Pharma will continue Xynomic's business as its main focus. Discover more about drugs for follicular lymphoma in development @ Follicular Lymphoma Clinical Trials The anticipated launch of these emerging therapies for follicular lymphoma are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the follicular lymphoma market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for follicular lymphoma is expected to grow from USD 1.4 billion in 2020 with a significant CAGR by 2034. This growth can be attributed to the introduction of upcoming therapies and the rise in the increasing incidence of follicular lymphoma. DelveInsight's latest published market report titled as Follicular Lymphoma Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the follicular lymphoma country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The follicular lymphoma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Incident Cases of Follicular Lymphoma Risk-specific Incident Cases of Follicular Lymphoma Stage-specific Incident Cases of Follicular Lymphoma Mutation-specific Incident Cases of Follicular Lymphoma Transplant Eligible and Ineligible Patient Pool of Follicular Lymphoma Refractory/Relapsed Incident Cases of Follicular Lymphoma The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM follicular lymphoma market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis up to 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this follicular lymphoma market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the follicular lymphoma market. Also, stay abreast of the mitigating factors to improve your market position in the follicular lymphoma therapeutic space. Related Reports Follicular Lymphoma Pipeline Follicular Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key follicular lymphoma companies, including Incyte Corporation, Genmab A/S, BeiGene, Merck & Co., ADC Therapeutics, Xynomic Pharmaceuticals, Nordic Nanovector, TG Therapeutics Inc, Allogene Therapeutics, MEI Pharma, Innovent Biologics, among others. Non-Hodgkin Lymphoma Market Non-Hodgkin Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key Non-Hodgkin lymphoma companies, including Roche, Pfizer, Amgen, Novartis, Teva Pharmaceuticals, Genentech, ACD Therapeutics, among others. Non-Hodgkin Lymphoma Pipeline Non-Hodgkin Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Non-Hodgkin lymphoma companies, including Novartis, AstraZeneca, Genentech, BioInvent, Genmab, SystImmune, Nordic Nanovector, Pacylex Pharmaceuticals, Artiva Biotherapeutics, Inc., Chipscreen Biosciences, Ltd., Timmune Biotech Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Gilead Sciences, Acerta Pharma BV, Adagene Inc, Conjupro Biotherapeutics, Inc., Rhizen Pharmaceuticals, Juventas Cell Therapy Ltd., Incyte Corporation, HUYA Bioscience International, SecuraBio, Genor Biopharma Co., Ltd., Kyowa Kirin Co., Ltd., Antengene Therapeutics Limited, Regeneron Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Xynomic Pharmaceuticals, Inc., BioTheryX, Inc., UWELL Biopharma, Kronos Bio, Bio-Thera Solutions, Spectrum Pharmaceuticals, Inc., Aptose Biosciences Inc., Miltenyi Biomedicine GmbH, Precision BioSciences, Inc., Teneobio, Inc., TCR2 Therapeutics, IGM Biosciences, Inc, among others. Diffuse Large B-cell Lymphoma Market Diffuse Large B-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key DLBCL companies, including AbbVie, Genmab, Merck, Roche, Xencor, Janssen, Denovo Biopharma, Calithera Biosciences IMV, Biogen, Autolus Therapeutics, Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Regeneron Pharmaceuticals, Debiopharm, Seagen, Takeda, AstraZeneca, Gilead Sciences, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2ImmunotherapyDrug ApprovalFast TrackPhase 3

26 Aug 2024

·www.fiercepharma.com

After FDA rejection, Regeneron gains nod in Europe for T-cell engager odronextamab

Regeneron has won approval in Europe for its blood cancer T-cell engager odronextamab five months after the FDA rejected the treatment under its accelerated pathway because of the timeline of its confirmatory trial. Five months after the FDA rejected Regeneron’s bid for accelerated approval of its T-cell engager odronextamab because of the immaturity of its confirmatory trial, the European Union has signed off on the treatment for two types of blood cancers.In winning the nod from the European Commission for relapsed or refractory follicular lymphoma (FL) and for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), Ordspono becomes Regeneron’s first approved bispecific antibody. The endorsement covers patients who have undergone two or more lines of systemic therapy.Separately, the EC also granted a first-time approval to SIFI’s Akantior (polyhexanide), which becomes the first therapy to treat the rare corneal infection acanthamoeba keratitis. The sudden, parasitic disorder can cause blindness and primarily affects those who wear soft contact lenses. The Italian company has received orphan drug designation from the FDA for polyhexanide as a potential treatment for both acanthamoeba keratitis and fungal keratitis. Regeneron’s approval was backed by phase 1 and phase 2 trials that provided remarkable data. In the ELM-2 study, patients with FL showed an 80% overall response rate (ORR), with 73% achieving a complete response (CR). The median duration of response (DoR) for the complete responders was 25 months.In the same study, patients with DLBCL who were CAR-T therapy-naïve had a 52% ORR, with 31% reaching CR and having an 18-month median DoR.Despite the results, the FDA sent Regeneron two complete response letters in March, rejecting the company’s application for accelerated approval because its confirmatory trials for odronextamab were not yet underway. The FDA and Regeneron need to agree to timelines of the trials “prior to resubmission,” the company said.The rejection came as the FDA is wrestling with how to adjudicate accelerated approvals. With the recent failures of some FDA-sanctioned drugs, the approval mechanism has come under scrutiny. A recent study published in the Journal of the American Medical Association showed that 80% of drugs approved under the pathway couldn't demonstrate survival benefits after five years.In April, the FDA's Oncology Center of Excellence chief Richard Pazdur, M.D., addressed the issue.“If we really believe that there are no other therapeutic alternatives, then there will be obviously some degree of flexibility,” Pazdur said. “When we do see, however, that there may be accelerated approval with the same class of drugs with the same diseases and with sponsors previously having most of the confirmatory study accrual already completed at the time of accelerated approval, we have to have a level playing field for all of the pharmaceutical companies.” In the case of odronextamab, there are other new treatments from its drug class on the market in the indications. Over the last 15 months, AbbVie and Genmab’s bispecific antibody Epkinly has gained FDA nods for both FL and DLBCL. Meanwhile, Roche has two T-cell engagers on the market: Columvi earned an FDA nod in DLBCL in June, and Lunsumino was approved by the FDA as a treatment for FL in December of 2022.All the endorsements for the therapies have been for third-line use. In clinical trials, each of the companies, including Regeneron, is combining the T-cell engagers with other medicines in attempt to move them into earlier treatment lines.“Ordspono marks the first approval from our bispecific antibody platform, which we hope will increasingly contribute to our growing portfolio of practice-changing medicines for oncology and other diseases,” George Yancopoulos, M.D., Ph.D., Regeneron’s chief scientific officer, said in a release.

Clinical ResultDrug ApprovalOrphan DrugAccelerated ApprovalImmunotherapy

26 Aug 2024

·firstwordpharma.com

After US rejection, Regeneron claims expected EU clearance for lymphoma bispecific

On Monday, Regeneron’s Ordspono (odronextamab) became the second CD20xCD3-targeting bispecific approved by the European Commission this month for patients with certain types of non-Hodgkin lymphoma (NHL), following AbbVie and Genmab's Tepkinly (epcoritamab). Both antibodies are now cleared to treat relapsed or refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. The rival therapies secured positive recommendations from the European Medicines Agency's drug advisory panel in June. The approvals come amid a shifting treatment landscape for NHL, with key opinion leaders (KOLs) suggesting that bispecifics are carving out an important role in the treatment algorithm, particularly for patients who are ineligible for or relapsing after CAR-T cell therapy. However, certain KOLs speaking with FirstWord expressed tempered enthusiasm for Ordspono given its late-to-market status and lack of clear differentiation in DLBCL. For further analysis, see Spotlight On: How KOLs are navigating an evolving NHL treatment landscape.Additionally, AbbVie and Genmab’s drug has found a commercial foothold in the US — where it’s marketed as Epkinly (epcoritamab-bysp) for both FL and DLBCL — while Regeneron’s has yet to find success in the region. Earlier this year, the FDA declined to grant Ordspono accelerated approval due to the enrollment status of confirmatory studies. (See – Spotlight On: Regeneron’s odronextamab forces FDA to draw line in sand on accelerated approvals).Backing response dataThe greenlight for Ordspono was based on data from the Phase II ELM-2 trial, as well as a 60-person cohort in the Phase I ELM-1 study of patients with DLBCL who had progressed after CAR-T. In the latter trial, the bispecific demonstrated an overall response rate (ORR) of 48%, with a median duration of response (DOR) of 15 months. The pivotal ELM-2 study comprised one cohort of 128 patients with FL, and a second 127-patient CAR-T therapy naive DLBCL arm. In individuals with FL, Ordspono achieved an ORR of 80%. Among those who experienced a complete response (73%), patients saw a median DOR of 25 months. The DLBCL arm demonstrated a 52% ORR, of which 31% achieved a complete response and had a median DOR of 18 months. More than half of patients across the two studies experienced cytokine release syndrome, the most common adverse reaction followed by neutropenia (41%), pyrexia (39%), anaemia (38%), thrombocytopenia (27%) and diarrhoea (24%).

Clinical ResultDrug ApprovalPhase 2ImmunotherapyCell Therapy

100 Deals associated with Epcoritamab

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Large B-cell lymphoma	CA	AbbVie, Inc.	13 Oct 2023
Recurrent Grade 3b Follicular Lymphoma	CA	AbbVie, Inc.	13 Oct 2023
Mediastinal large B-cell lymphoma	JP	Genmab A/S	25 Sep 2023
Recurrent Follicular Lymphoma	JP	Genmab A/S	25 Sep 2023
Refractory Follicular Lymphoma	JP	Genmab A/S	25 Sep 2023
Diffuse large B-cell lymphoma recurrent	EU	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse large B-cell lymphoma recurrent	IS	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse large B-cell lymphoma recurrent	LI	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse large B-cell lymphoma recurrent	NO	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse large B-cell lymphoma refractory	EU	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse large B-cell lymphoma refractory	IS	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse large B-cell lymphoma refractory	LI	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse large B-cell lymphoma refractory	NO	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse Large B-Cell Lymphoma	US	Genmab, Inc.	19 May 2023
High grade B-cell lymphoma	US	Genmab, Inc.	19 May 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Follicular Lymphoma	Phase 3	AU	AbbVie, Inc.	20 Sep 2022
Follicular Lymphoma	Phase 3	AT	AbbVie, Inc.	20 Sep 2022
Follicular Lymphoma	Phase 3	BE	AbbVie, Inc.	20 Sep 2022
Follicular Lymphoma	Phase 3	DK	AbbVie, Inc.	20 Sep 2022
Follicular Lymphoma	Phase 3	FR	AbbVie, Inc.	20 Sep 2022
Follicular Lymphoma	Phase 3	HU	AbbVie, Inc.	20 Sep 2022
Follicular Lymphoma	Phase 3	IL	AbbVie, Inc.	20 Sep 2022
Follicular Lymphoma	Phase 3	IT	AbbVie, Inc.	20 Sep 2022
Follicular Lymphoma	Phase 3	NZ	AbbVie, Inc.	20 Sep 2022
Follicular Lymphoma	Phase 3	KR	AbbVie, Inc.	20 Sep 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03625037 (EPCORE NHL-1, Pubmed)	Phase 2	Refractory Follicular Lymphoma Third line CD20	128	Epcoritamab 48 mg	vjpzrtksoi(inahgnpchm) = 6% of patients experienced immune effector cell-associated neurotoxicity syndrome with Epcoritamab 48 mg gzdqounmro (lryjttrzfn ) View more	Positive	13 Jun 2024
NCT04663347 (EPCORE NHL-2, ASCO2024) Manual	Phase 1/2	Diffuse Large B-Cell Lymphoma CD20 Positive	97	Epcoritamab + GemOx	ojjscptbtf(vhipvqedgo) = ynvhylpruw qriljtdoji (deudjrhrdn ) View more	Positive	24 May 2024
				Epcoritamab + GemOx (Kaplan–Meier estimates at 9 mo in pts with CR)	gpbdkflurw(awcveqkwet) = oyyhupybqk syuzmjfjgy (hbbwqvyeoz ) View more
NCT03625037 (EPCORE NHL-1, ASCO2024) Manual	Phase 1/2	Follicular Lymphoma Third line CD20 Positive	86	Epcoritamab (C1 OPT Cohort)	yqrnmukqdo(vsqqzotdfl) = fjpdhgwduq jvvrdqiamm (slappltshk ) View more	Positive	24 May 2024
				epcoritamab (Pivotal Cohor)	yqrnmukqdo(vsqqzotdfl) = ymhzcvodft jvvrdqiamm (slappltshk ) View more
NCT04663347 (EPCORE™ NHL-2, ASCO2024) Manual	Phase 1/2	Diffuse Large B-Cell Lymphoma Second line CD20 Positive	29	Epcoritamab + R-DHAX/C	zyphtpjuum(jajeqvvnxv) = fvstykawpv iibgtqqzxu (ecdvcopwak ) View more	Positive	24 May 2024
				Epcoritamab + R-DHAX/C (Progressed within 12 mo of initial tx)	zyphtpjuum(jajeqvvnxv) = buaobntmpw iibgtqqzxu (ecdvcopwak ) View more
NCT03625037 (NHL-1 EPCORE, ASCO2024) Manual	Phase 2	High grade B-cell lymphoma \| Diffuse Large B-Cell Lymphoma Second line CD20 Positive	157	Epcoritamab (DLBCL)	hzgarpkjhd(zwnzcrbotv) = ewjtwhutce thivkhsrhv (ovgiyrlcdd ) View more	Positive	24 May 2024
				Epcoritamab	hzgarpkjhd(zwnzcrbotv) = cskbaonlav thivkhsrhv (ovgiyrlcdd ) View more
NCT05451810 (EPCORE NHL-6, ASCO2024) Manual	Phase 2	Follicular Lymphoma \| Diffuse Large B-Cell Lymphoma Third line	36	SC epcoritamab (Priming SUD1)	jdscozovmq(tejgwjcfjq) = gngsrjowby dxucdsvlbm (lsliisytjx ) View more	Positive	24 May 2024
				SC epcoritamab (Intermediate SUD2)	jdscozovmq(tejgwjcfjq) = sjspwggxgy dxucdsvlbm (lsliisytjx ) View more
NCT04623541 (EPCORE CLL-1, EHA2024) Manual	Phase 1/2	Richter's syndrome CD20 Positive	35	Epcoritamab 48 mg	cxelgcwjwz(rewdcxxotg) = bsxlnodvgn pwmxwtnukl (snsibuuwxy ) View more	Positive	14 May 2024
NCT03888105 \| NCT02500407 \| NCT03625037 (ELM-2, EHA2024) Manual	Not Applicable	Follicular Lymphoma Third line CD3 \| CD20	81	Epcoritamab	wnqljcgain(azdygggqyb) = vktkgilrek noygregpij (orrcyegsqm ) View more	Positive	14 May 2024
				Mosunetuzumab	wnqljcgain(azdygggqyb) = jmwzatmxxd noygregpij (orrcyegsqm ) View more
SCHOLAR-5 (EHA2024) Manual	Not Applicable	Follicular Lymphoma Third line	128	Epcoritamab	jggchjvepm(qwaxoyybvf) = xavopdesaz udklfmudzp (rwsbgwhwjd ) View more	Positive	14 May 2024
				Standard of Care (SoC)	jggchjvepm(qwaxoyybvf) = dlrdlwzfse udklfmudzp (rwsbgwhwjd ) View more
NCT05283720 (EPCORE NHL-5, EHA2024) Manual	Phase 1/2	Diffuse Large B-Cell Lymphoma First line MYC \| CD20 Positive ... View more	27	Epcoritamab + pola-R-CHP	fhcrghqwaw(arkisskhdj) = CRS was low grade (32% G1, 16% G2)and primarily occurred after the first full dose (C1D15). CRS events occurred in 6/17 pts (35%; 3 G2) and 12/20pts (60%; 3 G2) receiving prophylactic dexamethasone or prednisone, respectively. All CRS resolved, withmedian time to resolution of 2 d (range: 1–6). szftubapjq (ppzvmucfxu ) View more	Positive	14 May 2024

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