Roche extols 'unprecedented' result with breast cancer drug
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.
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.
There was also a "clear positive trend" towards improved overall survival in the study, although that data is not yet mature, said Roche.
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.
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.
The new result could allow Roche to position giredestrant in an earlier treatment setting than other drugs in the class.
As it stands, there are two oral SERDs on the market – Menarini/Stemline's Orserdu (elacestrant) and Eli Lilly's Inluriyo (imlunestrant) – both of which are currently approved as second-line treatments for advanced HR-positive, HER2-negative breast cancer with ESR1 mutations.
Both drugs are also being tested in the adjuvant setting – Orserdu in the ELEGANT trial and Inluriyo in EMBER-4 – while AstraZeneca is also looking at early breast cancer with its oral SERD camizestrant in the CAMBRIA-1 and CAMBRIA-2 studies.
Roche has stolen a march on its rivals with the new data, however, and also went one better than its rivals with the evERA 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.
"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.
"Given that [HR]-positive breast cancer accounts for approximately 70% of cases diagnosed, these findings – together with recent data in the advanced…setting – suggest that giredestrant has the potential to improve outcomes for many people with this disease."
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.
