AstraZeneca’s Etcamah (camizestrant) failed to significantly delay disease progression in SERENA-4, a Phase 3 trial evaluating the oral SERD as part of a standard first-line regimen for advanced ER-positive, HER2-negative breast cancer. AstraZeneca said the study showed a numerical improvement in progression-free survival that did not reach statistical significance, with detailed data expected later. The setback adds pressure to AstraZeneca’s strategy for earlier use of SERDs, following an accelerated approval earlier this month tied to ESR1 mutation detection via an FDA-approved test. It also reflects industry scrutiny after another oral SERD, Roche’s giredestrant, failed in a similar label-expansion setting. AstraZeneca now looks to other readouts in its pipeline, including the AVANZAR study testing Datroway in first-line non-small-cell lung cancer, as Etcamah’s next regulatory steps remain under review pending final results.
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