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Review
. 2020 Jan-Dec;12(1):1703531.
doi: 10.1080/19420862.2019.1703531.

Antibodies to watch in 2020

Affiliations
Review

Antibodies to watch in 2020

Hélène Kaplon et al. MAbs. 2020 Jan-Dec.

Abstract

This 2020 installment of the annual 'Antibodies to Watch' series documents the antibody therapeutics approved in 2019 and in regulatory review in the United States or European Union, as well as those in late-stage clinical studies, as of November 2019*. At this time, a total of 5 novel antibody therapeutics (romosozumab, risankizumab, polatuzumab vedotin, brolucizumab, and crizanlizumab) had been granted a first approval in either the US or EU, and marketing applications for 13 novel antibody therapeutics (eptinezumab, teprotumumab, enfortumab vedotin, isatuximab, [fam-]trastuzumab deruxtecan, inebilizumab, leronlimab, sacituzumab govitecan, satralizumab, narsoplimab, tafasitamab, REGNEB3 and naxituximab) were undergoing review in these regions, which represent the major markets for antibody therapeutics. Also as of November 2019, 79 novel antibodies were undergoing evaluation in late-stage clinical studies. Of the 79 antibodies, 39 were undergoing evaluation in late-stage studies for non-cancer indications, with 2 of these (ublituximab, pamrevlumab) also in late-stage studies for cancer indications. Companies developing 7 (tanezumab, aducanumab, evinacumab, etrolizumab, sutimlimab, anifrolumab, and teplizumab) of the 39 drugs have indicated that they may submit a marketing application in either the US or EU in 2020. Of the 79 antibodies in late-stage studies, 40 were undergoing evaluation as treatments for cancer, and potentially 9 of these (belantamab mafodotin, oportuzumab monatox, margetuximab, dostarlimab, spartalizumab, 131I-omburtamab, loncastuximab tesirine, balstilimab, and zalifrelimab) may enter regulatory review in late 2019 or in 2020. Overall, the biopharmaceutical industry's clinical pipeline of antibody therapeutics is robust, and should provide a continuous supply of innovative products for patients in the future. *Note on key updates through December 18, 2019: 1) the US Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (Padcev) on December 18, 2019, bringing the total number of novel antibody therapeutics granted a first approval in either the US or EU during 2019 to 6; 2) the European Commission approved romosozumab on December 9, 2019; 3) the European Medicines Agency issued a positive opinion for brolucizumab; 4) Sesen Bio initiated a rolling biologics license application (BLA) on December 6, 2019; 5) GlaxoSmithKline submitted a BLA for belantamab mafodotin; and 6) the status of the Phase 3 study (NCT04128696) of GSK3359609, a humanized IgG4 anti-ICOS antibody, in patients with head and neck squamous cell carcinoma was updated to recruiting from not yet recruiting.

Keywords: Antibody therapeutics; European Medicines Agency; Food and Drug Administration; cancer; immune-mediated disorders; monoclonal antibodies.

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Figures

Figure 1.
Figure 1.
Cumulative number of antibody therapeutics first approved in the US or EU, 1986–2019. *Data available as of November 28, 2019. Biosimilar antibody and Fc fusion protein products were excluded. A table of US- and EU-approved antibody therapeutics is available at https://www.antibodysociety.org/resources/approved-antibodies/.
Figure 2.
Figure 2.
Antibody therapeutics in late-stage clinical studies. 2020 values based on data publicly available as of December 5, 2019; other data from ‘Antibodies to watch’ articles published in mAbs starting in 2010. “Late-stage” clinical studies include pivotal or registrational Phase 2, Phase 2/3 or Phase 3 studies. Biosimilar antibody and Fc fusion protein products were excluded. A table of antibodies in late-stage studies sponsored by commercial firms is maintained by The Antibody Society.

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