François-Clément Bidard, Head of Center for Clinical Investigation CIC-2501 at Inserm, shared on LinkedIn:
“After persevERA, SERENA-4 failed. SERENA-6 was the right way to go – adaptive oncology has a brilliant future in view.
‘There is no bad drug, only bad trial designs.’
originally from Dr Dan Von Hoff, quoted almost every week by one of his mentees, Dr DIERAS Véronique, who was one of my mentors during my residency at Institut Curie.
For those not following closely ER+ metastatic BC drug dev, oral SERDs are mostly active in ESR1mutant mBC.
persevERA and SERENA-4 were two large phase 3 trials which followed a candid (yet usual) strategy: giving new drug to all patients from the start of the 1st line, even if ESR1m are very rare in this setting and despite the failure of a prior trial (Parsifal).
In contrast, with SERENA-6, AstraZeneca chose to follow the science (and a succesful trial, PADA-1). Tracking and targeting ESR1m rising during 1st line, before the diseases becomes resistant and progresses, is the best use of oral SERDs in ER+ mBC!”
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