Astra places its bet in oestrogen receptor degradation

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Astrazeneca had boasted two selective oestrogen receptor degraders (Serds), but one of these, AZD9496, has been discontinued, it revealed on today’s fourth-quarter call. However, the second, AZD9833, has just moved into phase III, meaning that there are now four pivotal-stage Serds battling for a breast cancer niche some think is worth $2-3bn a year. Sanofi’s most important first-half event is readout of amcenestrant’s potentially registrational phase II Ameera-3 trial, though this targets second-line use. The first-line Ameera-5 study will not read out for some time, but Asco could see phase I data from yet another study, Ameera-1, that Sanofi last week said “gave us confidence to kick off ... the pivotal trial”. Radius Health’s elacestrant will be the first to yield pivotal data, but does not appear to target the front-line setting. Roche, meanwhile, is now on its third Serd, having scrapped two Seragon-derived assets. Astra said AZD9496 was canned based on initial safety and efficacy results, but called AZD9833 a next-generation Serd that forms an integral part of its breast cancer strategy. The group developed the first ever Serd, Faslodex, a drug that struggled with poor bioavailability, and will not give up this market without a fight.

Serds in phase III development for ER+ve/Her2-ve breast cancer
Project Company Study Design Primary endpoint(s) Status
Elacestrant Radius Health/ Menarini Emerald 2nd-line, postmenopausal, vs SoC PFS in ESR1-mut & PFS in all-comers Reads out Q4 2021
Amcenestrant (SAR439859) Sanofi Ameera-5 1st-line, vs Femara PFS First patient in Q4 2020
Giredestrant (RG6171) Roche BO41843 1st-line, Ibrance combo vs Femara + Ibrance PFS First patient in Q4 2020
Camizestrant (AZD9833) Astrazeneca Serena-4 1st-line, Ibrance combo vs Arimidex + Ibrance PFS First patient in Q1 2021

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