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.