Lilly fans the degrader Embers

So far, oral SERDs have largely disappointed, but Lilly might be bucking this trend. The company’s Ember-3 trial of imlunestrant in second-line ER-positive, HER2-negative breast cancer was positive, Lilly slipped into its third-quarter earnings release on Wednesday. No further details were given, so the success is difficult to gauge; the magnitude of any win is especially important as SERDs have tended to show a benefit only in patients with ESR1 mutations. It is unclear whether Ember-3, which has co-primary endpoints of PFS in all-comers and ESR1 mutants, enriched for this subgroup. Meanwhile, Arvinas, which is developing its SERD vepdegestrant alongside Pfizer, confirmed on Wednesday that readout from its analogous second-line trial, Veritac-2, was due in the fourth quarter of 2024 or first quarter of 2025; data had once been expected in the second half of this year. Many SERD players have now shifted to first-line and even earlier breast cancer, with the exception of Olema, whose phase 3 second-line Opera-1 trial of its hopeful, palazestrant, is set to read out in 2026. The only approved SERD is Menarini’s Orserdu, which is restricted to ESR1 mutants.