Roche\u2019s giredestrant was shown to reduce the risk of breast cancer progression or death by 62% for a specific cohort of a phase 3 trial, as the pharma plans for the oral selective estrogen receptor degrader (SERD) to benefit \u201call comers.\u201d<\/p>\n
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 Afinitor (everolimus) or standard of care.<\/p>\n
Roche announced last month<\/a> that the study hit its co-primary endpoints of demonstrating better progression-free survival (PFS) than standard of care in\u00a0both the intention-to-treat (ITT) and ESR1-mutated populations. The Swiss pharma arrived at the European Society for Medical Oncology (ESMO) conference in Berlin this weekend armed with detailed data.<\/p>\n The findings tied giredestrant to 44% and 62% improvement in PFS for the ITT and ESR1 cohorts, respectively. Median PFS was 8.7 months in the ITT arm and 9.9 months in the ESR1-mutated population, compared to 5.4 months for the comparator arms.<\/p>\n While the most impressive data was from the ESR1-mutated patients, the pharma is confident that giredestrant will \u201cwork in all-comers,\u201d according to Charles Fuchs, M.D., global head of oncology and hematology drug development.<\/p>\n \u201cOur goal was\u2014and still is\u2014to make this drug available and useful for all-comers and across all settings of metastatic and curative settings of HR-positive breast cancer,\u201d Fuchs told Fierce in an interview on the sidelines of the conference.<\/p>\n \u201cWhen we look at overall survival, which is immature for the non-mutants, we see a hazard ratio and a trend that we think is clinically meaningful,\u201d he added.<\/p>\n It means Fuchs and his team remain confident that giredestrant can take on the competition, such as AstraZeneca\u2019s injectable SERD Faslodex, also known as fulvestrant.<\/p>\n \u201cWe think, in aggregate, the totality of the evidence says that giredestrant is better than fulvestrant, not only in the intent-to-treat and the mutants, but in the non-mutants,\u201d he added. \u201cAnd we believe this drug should be available in this setting, in this combination, for all patients.\u201d<\/p>\n As part of this strategy, Roche is already evaluating giredestrant in four other late-stage breast cancer studies, including the persevERA trial for estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer, which is due to read out in the first half of next year.<\/p>\n Roche \u201cfeels good about\u201d persevERA, according to Fuchs, who cited previous clinical evidence showing that \u201cin a setting where the tumor is sensitive to ER, it does appear to be better.\u201d<\/p>\n The data update at ESMO marks an ongoing return to favor for giredestrant after the drug contributed to a downturn in excitement about oral SERDs in 2022. That year, giredestrant\u00a0failed<\/a>\u00a0a midphase breast cancer test, while Sanofi\u2019s rival asset amcenestrant\u00a0flunked<\/a>\u00a0a pivotal trial. The field has shifted again since then, with Menarini\u2019s Orserdu coming to market in second-line patients and AstraZeneca\u2019s camizestrant\u00a0improving<\/a>\u00a0outcomes in first-line patients with emergent ESR1 mutations.<\/p>\n Looking back at that bump in the road for giredestrant, Fuchs described the failed breast cancer study as \u201creally a high-risk bet in a population that was extremely endocrine-resistant.\u201d<\/p>\n \u201cSo I think it was a useful phase 2 study,\u201d he concluded. \u201cWe learned a lot from it \u2026 and we now have studies that I think are designed to test the right hypothesis.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"Roche\u2019s giredestrant was shown to reduce the risk of breast cancer progression or death by 62% for a…\n","protected":false},"author":2,"featured_media":81770,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[124],"tags":[1115,207,16594,7220,9275,134],"class_list":["post-81769","post","type-post","status-publish","format-standard","has-post-thumbnail","category-roche","tag-biotech","tag-breast-cancer","tag-clinical-data","tag-esmo-2025","tag-fierce-biotech-homepage","tag-roche"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@ch\/116733063110469890","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/81769","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=81769"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/81769\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media\/81770"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media?parent=81769"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/categories?post=81769"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/tags?post=81769"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}