Esmo 2022 – Sanofi and Roche’s duelling Serd duds

An Esmo abstract has shown why Sanofi was right to can amcenestrant: the Serd showed absolutely no benefit over physician’s choice in the second-line Ameera-3 study in Her2-negative breast cancer. Control numerically outperformed amcenestrant, with the PFS primary endpoint yielding a hazard ratio above 1.0, meaning that patients given amcenestrant were numerically more likely to progress than those on control. A second Serd failure, that of Roche’s giredestrant in the Acelera trial, also features among Esmo’s regular presentations, and appears slightly better: a non-significant 19% reduction in risk of progression favours giredestrant, while in ESR1 mutants the benefit was 40% – though there were not enough patients in this subgroup for this to be meaningful. Roche is pinning its hopes with giredestrant on front-line use, while Sanofi finally pulled the plug on amcenestrant when its first-line Ameera-5 trial also failed. The only novel oral Serd to work so far has been Radius/Menarini’s elacestrant, likely thanks to its trial having been enriched for ESR1 mutants. Curiously, however, this project is not being tested in the front line.

Cross-trial comparison of novel oral Serds in 2nd-line HR+/Her2- breast cancer
  mPFS
Project (company) Trial All comers ESR1mut
Elacestrant (Radius/Menarini) Emerald 2.8mth vs 1.9mth HR=0.70, p=0.002 3.8mth vs 1.9mth HR=0.55, p=0.0005
Giredestrant (Roche) Acelera Medians not disclosed in Esmo abstract 211MO HR=0.81, p=0.18 Medians not disclosed in Esmo abstract 211MO  HR=0.60 (95% CI upper bound of 1.03)
Amcenestrant (Sanofi) Ameera-3 3.6mth vs 3.7mth HR=1.051, p=0.6437 Not given in Esmo abstract 212MO
Source: Asco & Esmo.

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