{"id":81821,"date":"2026-06-11T20:32:08","date_gmt":"2026-06-11T20:32:08","guid":{"rendered":"https:\/\/www.europesays.com\/ch\/81821\/"},"modified":"2026-06-11T20:32:08","modified_gmt":"2026-06-11T20:32:08","slug":"roche-reports-phase-3-breast-cancer-victory-for-oral-serd","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/ch\/81821\/","title":{"rendered":"Roche reports phase 3 breast cancer victory for oral SERD"},"content":{"rendered":"<p dir=\"ltr\">Roche\u00a0<a href=\"https:\/\/www.businesswire.com\/news\/home\/20250921368723\/en\/Positive-Phase-III-Results-Show-Genentechs-Giredestrant-Significantly-Improved-Progression-Free-Survival-in-ER-positive-Advanced-Breast-Cancer\" rel=\"nofollow noopener\" target=\"_blank\">has reported<\/a> a phase 3 win for its oral selective estrogen receptor degrader (SERD), bouncing back from an earlier setback to deliver data that could support filings for approval in breast cancer.<\/p>\n<p dir=\"ltr\">The candidate, giredestrant, contributed to a downturn in excitement about oral SERDs in 2022. That year, giredestrant\u00a0<a href=\"https:\/\/www.fiercebiotech.com\/biotech\/weeks-after-sanofi-flop-roches-rival-oral-serd-flunks-phase-2-breast-cancer-test\" rel=\"nofollow noopener\" target=\"_blank\">failed<\/a> a midphase test and Sanofi\u2019s rival asset amcenestrant\u00a0<a href=\"https:\/\/www.fiercebiotech.com\/biotech\/long-wait-pivotal-data-sanofis-oral-serd-ends-failure\" rel=\"nofollow noopener\" target=\"_blank\">flunked<\/a> a pivotal trial. The field has shifted again since then, with Menarini\u2019s Orserdu coming to market in second-line patients and AstraZeneca\u2019s camizestrant\u00a0<a href=\"https:\/\/www.fiercebiotech.com\/biotech\/asco-astrazenecas-oral-serd-tied-56-pfs-benefit-phase-3-breast-cancer-trial\" rel=\"nofollow noopener\" target=\"_blank\">improving<\/a> outcomes in first-line patients with emergent ESR1 mutations.<\/p>\n<p dir=\"ltr\">Roche\u2019s calendar for 2025 and 2026 includes data drops that will inform whether giredestrant finds a place in the treatment arsenal. The drugmaker shared data from one of the trials Monday, reporting that a phase 3 study in a previously treated population of breast cancer patients met its co-primary endpoints.<\/p>\n<p dir=\"ltr\">The evERA trial enrolled people with ER-positive, HER2-negative locally advanced or metastatic breast cancer who had previously received a CDK 4\/6 inhibitor and endocrine therapy. Patients received the all-oral combination of giredestrant and everolimus or standard of care.\u00a0<\/p>\n<p dir=\"ltr\">The giredestrant combination was associated with better progression-free survival than standard of care in both the intention-to-treat and ESR1-mutated populations, achieving the co-primary endpoints of the trial. Overall survival data were immature as of the data cutoff but trending in favor of the study drug. Follow-up is continuing to the next analysis.<\/p>\n<p dir=\"ltr\">Roche said the study enriched for ESR1-mutated patients above the natural prevalence. The company is yet to disclose what proportion of patients had the mutation or say how the drug candidate performed in people with ESR1-wild-type breast cancer. Evidence of efficacy outside of people with ESR1 mutations could expand the market opportunity for giredestrant and other oral SERDs.<\/p>\n<p dir=\"ltr\">The evERA trial only covers a slice of what Roche sees as a multibillion-dollar opportunity. Roche is closing in on results from trials that will have a bigger impact on the prospects of giredestrant, with data from the first-line persevERA and adjuvant lidERA studies due in 2026.<\/p>\n","protected":false},"excerpt":{"rendered":"Roche\u00a0has reported a phase 3 win for its oral selective estrogen receptor degrader (SERD), bouncing back from an&hellip;\n","protected":false},"author":2,"featured_media":81822,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[124],"tags":[1115,207,16594,42004,9275,134],"class_list":["post-81821","post","type-post","status-publish","format-standard","has-post-thumbnail","category-roche","tag-biotech","tag-breast-cancer","tag-clinical-data","tag-clinical-trial-data","tag-fierce-biotech-homepage","tag-roche"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@ch\/116733381632821982","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/81821","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/comments?post=81821"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/81821\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media\/81822"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media?parent=81821"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/categories?post=81821"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/tags?post=81821"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}