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Results from the aceIERA trial, recently published on Journal of Clinical Oncology, showed that the oral, selective estrogen receptor antagonist and degrader (SERD) giredestrant improve outcomes compared with physician’s choice of endocrine therapy in patients with pretreated, estrogen receptor–positive, HER2-negative, advanced breast cancer.
The randomized aceIERA breast cancer study involved 303 patients with HR+/HER2- advanced breast cancer whose disease progressed after 1-2 lines of systemic therapy. Patients were randomly assigned to giredestrant (30 mg oral once daily) or fulvestrant/aromatase inhibitor until disease progression or unacceptable toxicity; the primary end point was investigator-assessed progression-free survival (INV-PFS). After a median follow-up of 7.9 months the INV-PFS hazard ratio was 0.81; INV-PFS was 0.60 in patients with a detectable ESR1mutation versus 0.88 in patients with no ESR1 mutation detected. Giredestrant was well tolerated, with a safety profile comparable to physician’s choice of endocrine therapy and consistent with known endocrine therapy risks. However, giredestrant did not show statistically significant superiority to physician’s choice of endocrine therapy with regards to INV-PFSl. In patients with ESR1-mutated tumors, there was a trend toward favorable benefit with giredestrant, so the JCO associate editor Gini Fleming wrote: «Hopeful results continue to emerge from studies of novel ER-targeting drugs, with a number appearing to show more activity than historically available agents in the presence of a tumor ESR1 mutation. However their significance in the treatment algorithm for women with ER+, HER2-negative breast cancer remains to be determined».
Results from the aceIERA trial, recently published on Journal of Clinical Oncology, showed that the oral, selective estrogen receptor antagonist and degrader (SERD) giredestrant improve outcomes compared with physician’s choice of endocrine therapy in patients with pretreated, estrogen receptor–positive, HER2-negative, advanced breast cancer.
The randomized aceIERA breast cancer study involved 303 patients with HR+/HER2- advanced breast cancer whose disease progressed after 1-2 lines of systemic therapy. Patients were randomly assigned to giredestrant (30 mg oral once daily) or fulvestrant/aromatase inhibitor until disease progression or unacceptable toxicity; the primary end point was investigator-assessed progression-free survival (INV-PFS). After a median follow-up of 7.9 months the INV-PFS hazard ratio was 0.81; INV-PFS was 0.60 in patients with a detectable ESR1mutation versus 0.88 in patients with no ESR1 mutation detected. Giredestrant was well tolerated, with a safety profile comparable to physician’s choice of endocrine therapy and consistent with known endocrine therapy risks. However, giredestrant did not show statistically significant superiority to physician’s choice of endocrine therapy with regards to INV-PFSl. In patients with ESR1-mutated tumors, there was a trend toward favorable benefit with giredestrant, so the JCO associate editor Gini Fleming wrote: «Hopeful results continue to emerge from studies of novel ER-targeting drugs, with a number appearing to show more activity than historically available agents in the presence of a tumor ESR1 mutation. However their significance in the treatment algorithm for women with ER+, HER2-negative breast cancer remains to be determined».
