Roche’s oral selective oestrogen receptor degrader (SERD) giredestrant has achieved what the company says is a stellar result in an early breast cancer trial, building on earlier data in more advanced disease.<\/p>\n
The topline readout of the lidERA trial in patients with HR-positive, HER2-negative early breast cancer has shown a statistically significant improvement in invasive disease-free survival (iDFS) with giredestrant versus standard-of-care endocrine therapy when used as adjuvant (post-surgery) therapy to prevent the disease from coming back.<\/p>\n
There was also a “clear positive trend” towards improved overall survival in the study, although that data is not yet mature, said Roche.<\/p>\n
According to the company, giredestrant is the first oral SERD to show a benefit in the adjuvant setting, an “unprecedented result” that would position the drug as a new standard of care if it gets approved for marketing.<\/p>\n
Most breast cancer diagnoses are made at an early stage, and currently up to a third of people eventually experience recurrence on or after adjuvant endocrine therapy.<\/p>\n
The new result could allow Roche to position giredestrant in an earlier treatment setting than other drugs in the class.<\/p>\n
As it stands, there are two oral SERDs on the market \u2013 Menarini\/Stemline’s Orserdu<\/a> (elacestrant) and Eli Lilly’s Inluriyo<\/a> (imlunestrant) \u2013 both of which are currently approved as second-line treatments for advanced HR-positive, HER2-negative breast cancer with ESR1 mutations.<\/p>\n Both drugs are also being tested in the adjuvant setting \u2013 Orserdu in the ELEGANT trial and Inluriyo in EMBER-4 \u2013 while AstraZeneca is also looking at early breast cancer with its oral SERD camizestrant in the CAMBRIA-1 and CAMBRIA-2 studies.<\/p>\n Roche has stolen a march on its rivals with the new data, however, and also went one better than its rivals with the evERA<\/a> study of giredestrant as a second-line therapy for advanced HR-positive, HER2-negative breast cancer, after showing efficacy in an all-comer patient population, regardless of ESR1 status.<\/p>\n “Today’s results underscore the potential of giredestrant as a new endocrine therapy of choice for people with early-stage breast cancer, where there is a chance for cure,” said Levi Garraway, Roche’s chief medical officer.<\/p>\n “Given that [HR]-positive breast cancer accounts for approximately 70% of cases diagnosed, these findings \u2013 together with recent data in the advanced\u2026setting \u2013 suggest that giredestrant has the potential to improve outcomes for many people with this disease.”<\/p>\n Roche is also running the persevERA trial of giredestrant plus Pfizer’s CDK4\/6 inhibitor Ibrance (palbociclib) versus letrozole plus Ibrance as first-line treatment for HR-positive, HER2-negative, endocrine-sensitive, recurrent locally advanced or metastatic breast cancer.<\/p>\n Image by Marijana<\/a> from Pixabay<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"Roche’s oral selective oestrogen receptor degrader (SERD) giredestrant has achieved what the company says is a stellar result…\n","protected":false},"author":2,"featured_media":44938,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[124],"tags":[134],"class_list":{"0":"post-44937","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-roche","8":"tag-roche"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@ch\/116358623083349152","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/44937","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=44937"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/44937\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media\/44938"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media?parent=44937"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/categories?post=44937"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/tags?post=44937"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}