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.
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.
