FDA approves novel drug for advanced or metastatic breastcancer
, experts raised concerns about the adequacy of the"standard of care" control arm in EMERALD, particularly that single agents were used at a time when combination therapy is becoming more common.
"The expression 'standard of care' is applied generously, as the control arm is restricted" to single agents and no combinations, which"may have led to a substandard" comparison group, Timothée Olivier, MD, Geneva University Hospital, Switzerland, and Vinay Prasad, MD, MPH, University of California San Francisco, said in an editorial quoted in the piece.
EMERALD investigators acknowledged that there were issues with the control group, noting that in the"United States and Europe, combination therapy with fulvestrant" — instead of single agents —"is increasingly being used as the second-line [standard of care] treatment." However, the goal of the study"was to compare a novel endocrine therapy vs currently available endocrine therapies," not combination regimens, the investigators said.
Also,"the benefit of elacestrant over fulvestrant and AIs in our monotherapy trial…suggests that incorporating elacestrant as the preferred endocrine therapy backbone in future earlier-line combination studies is a promising strategy.
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