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“Antibodies to Watch in 2024” is now online!

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In this 15th installment of the annual ‘Antibodies to Watch’ article series, we review commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those granted a first approval in any country in 2023. 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.

Download or read the full paper here.

The complete abstract is here: 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.

Lebrikizumab (Ebglyss) approved in the European Union

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On November 17, 2023, Almirall S.A. announced that the European Commission approved EBGLYSS (lebrikizumab) for the treatment of adult and adolescent patients (12 years and older with a body weight of at least 40 kg) with moderate-to-severe atopic dermatitis (AD), who are candidates for systemic therapy. Lebrikizumab (Ebglyss) is a humanized, hinge-stabilized (S228P mutation) IgG4k antibody that targets IL-13, a key mediator of the pro-inflammatory response and enhances neuronal responses to the persistent itch stimuli in atopic dermatitis.

The approval in the European Union is based on results from three phase 3 trials evaluating the safety and efficacy of lebrikizumab in adults and adolescents >12 years of age with atopic dermatitis. Advocate 1 (NCT04146363) and Advocate 2 (NCT04178967) are randomized, double-blind, placebo-controlled, parallel-group studies in which patients with moderate-to-severe atopic dermatitis received either an initial dose of 500 mg of lebrikizumab followed by 250 mg lebrikizumab Q2W, or placebo for a 16-week treatment period. Following the 16 weeks, patients who received a clinical response to lebrikizumab were re-randomized to receive lebrikizumab Q2W or Q4W, or placebo, for another 36 weeks. The primary endpoints were an Investigator Global Assessment (IGA) score of clear or almost clear (0 or 1, respectively) skin with reduction of at least two points from baseline and at and least 75% reduction in the Eczema Area and Severity Index (EASI-75) score. Both Advocate 1 and Advocate 2 met their primary endpoints, with the IGA outcome being achieved in 43.1% of the lebrikizumab cohort (n=283) compared to 12.7% in placebo cohort (n=141) for Advocate 1, and 33.2% of the lebrikizumab cohort (n=281) compared to 10.8% in the placebo cohort (n=146) for Advocate 2. [1] The third Phase 3 study, Adhere (NCT04250337), is a 16-week randomized, double-blind, parallel-group study which investigated the efficacy of lebrikizumab in combination with topical corticosteroids in 211 patients with AD. Patients were randomized 2:1 to receive either 250mg SC lebrikizumab Q2W after an initial loading dose of 500 mg, or placebo, in combination with topical steroids, either mid-potency (0.1% triamcinolone acetonide cream) or low-potency (1% hydrocortisone cream). After 16 weeks, IGA of 0 or 1 with a 2 or more-point reduction from baseline was achieved by 41.2% of the lebrikizumab cohort compared to 22.1% of the placebo cohort, with statistical significance being reached as early as 8 weeks. [2] There was also a significantly greater proportion of patients achieving EASI-75 responses.

Almirall licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including atopic dermatitis, in Europe. Eli Lilly and Company has exclusive rights for the development and commercialization of the product in the United States and the rest of the world, not including Europe. Lilly has submitted a marketing application for lebrikizumab for atopic dermatitis to the US Food and Drug Administration.

  1. Silverberg JI, Guttman-Yassky E, Thaçi D, Irvine AD, Stein Gold L, Blauvelt A, Simpson EL, Chu CY, Liu Z, Gontijo Lima R, et al. Two Phase 3 trials of lebrikizumab for moderate-to-severe atopic dermatitis. N Engl J Med. 2023;388(12):1080-1091. Doi: 10.1056/NEJMoa2206714.
  2. Simpson EL, Gooderham M, Wollenberg A, Weidinger S, Armstrong A, Soung J, Ferrucci S, Lima RG, Witte MM, Xu W, et al. Efficacy and safety of lebrikizumab in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis: A randomized clinical trial (Adhere). JAMA Dermatol. 2023;159(2):182-191. Doi: 10.1001/jamadermatol.2022.5534.

Wondering which Antibodies to Watch in 2023?

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Join us for our next webinar to learn which late-stage antibodies you should watch next year!

Registration is open!

Antibodies to Watch in 2023

 

Thursday January 12, 2023, 11am ET / 4pm CET

Speakers: Drs. Janice Reichert, Silvia Crescioli, Alicia Chenoweth & Jyothsna Visweswaraiah

“Antibodies to Watch in 2023” highlights key events in commercial monoclonal antibody therapeutics development that occurred in 2022 and forecasts events that might occur in 2023. In this presentation, we will discuss the antibody therapeutics granted first approvals in either the United States or European Union in 2022, which include 4 bispecific antibodies ((tebentafusp, faricimab, mosunetuzumab and teclistamab) and 1 ADC (mirvetuximab soravtansine). We will also discuss approvals for antibody therapeutics that were first granted in China or Japan in 2022, which include 2 bispecific antibodies (cadonilimab and ozoralizumab). Globally, at least 24 investigational antibody therapeutics are undergoing review by regulatory agencies. Our data show that, with antibodies for COVID-19 excluded, the late-stage commercial clinical pipeline grew by ~20% in the past year to include nearly 140 investigational antibody therapeutics that were designed using a wide variety of formats and engineering techniques. Of those in late-stage development, marketing application submissions for at least 23 may occur by the end of 2023, of which 5 are bispecific (odronextamab, erfonrilimab, linvoseltamab, zanidatamab, and talquetamab) and 2 are ADCs (datopotamab deruxtecan, and tusamitamab ravtansine).

Everyone who registers will receive 3 reminders before the event, as well as the link to the On Demand version when it is available.

Registration is open!

Tezspire (tezepelumab) approved in the European Union for severe asthma

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On September 19, 2022, the European Commission (EC) approved AstraZeneca’s Tezspire (tezepelumab) as an add-on maintenance treatment in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product in the European Union.

The EC’s approval was based on results from the PATHFINDER clinical trial program, which included the placebo-controlled NAVIGATOR Phase 3 trial (NCT03347279), which evaluated the effects of tezepelumab in adults and adolescents with severe uncontrolled asthma. In this study, patients received tezepelumab (210 mg; n=529) or placebo (n=532) SC every 4 weeks for 52 weeks. Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy in this study. For the tezepelumab group, the annualized rate of asthma exacerbations was 0.93 (95% CI, 0.80 to 1.07), while the rate was 2.10 (95% CI, 1.84 to 2.39) with placebo (rate ratio, 0.44; 95% CI, 0.37 to 0.53; P<0.001). Overall, data from the study indicated that, compared to those administered placebo, patients who received tezepelumab had fewer exacerbations and better lung function, asthma control, and health-related quality of life. Full results of the NAVIGATOR trial were published in The New England Journal of Medicine in May 2021.

Tezspire has been approved in the US and other countries for the treatment of severe asthma.

Interested in more information about approved antibody therapeutics? Explore our searchable table of antibody therapeutic products for details.

Vabysmo™ (faricimab) approved in the European Union for ophthalmic disorders

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On September 15, 2022, the European Commission approved Vabysmo ™ (faricimab) for the treatment of wet, or neovascular, age-related macular degeneration (AMD) and visual impairment due to diabetic macular edema (DME). Faricimab (RO6867461, RG7716) is an anti-vascular endothelial growth factor-A (VEGF-A) and anti-angiopoietin-2 (Ang-2) bispecific antibody derived from Roche’s CrossMab technology.

The approval in the European Union was based in part on results from four Phase 3 studies in wet AMD and DME. The TENAYA (NCT03823287) and LUCERNE (NCT03823300) studies evaluated the effects of faricimab (6.0 mg administered at fixed intervals of every two, three, or four months) and aflibercept (Eylea®) (2.0 mg administered at fixed two-month intervals) in wet AMD patients. The YOSEMITE (NCT03622580) and RHINE studies (NCT03622593) compared the effects of faricimab (6.0 mg administered at personalized treatment intervals (PTI) of up to four months or 6.0 mg administered at fixed two-month intervals) to those of aflibercept (2.0 mg administered at fixed two-month intervals) in DME patients. Results of the TENAYA and LUCERNE and YOSEMITE and RHINE studies were published in The Lancet.

Interested in more information? Explore our searchable table of antibody therapeutics approved in the EU or US for details.