Philippe Aftimos, Clinical Trials Development Leader at Institut Jules Bordet, shared on X:
“The FDA approved the Imlunestrant (oral SERD) + Abemaciclib combo for ER+/HER2– MBC with an ESR1 mut with disease progression following at least 1 line of endocrine therapy based on results from EMBER-3 (COI).
Why was the approval only in tumors with an ESR1 mut (panel A) while median PFS was also longer in the ESR1m not detected cohort (panel B)? Because single-agent Imlunestrant is not SOC in all-comers as it did not improve PFS vs SOC endocrine therapy.
To date, there is no approval for an oral SERD in breast cancer without a detected ESR1 mutation. Will the early positive results with Giredestrant in the lidERA trial in the adjuvant setting of HR+/HER2- early breast cancer change that? To be followed.”
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