A Roche drug in a new class of drugs for breast cancer is completed in a Phase 2 study, marking the latest stumble in a burgeoning field of oral therapies that degrade a key protein to stimulate cell growth cancerous. The results from these clinics follow disappointing data previously reported by Sanofi and Radius Health, Roche's main rivals to tackle this cancer target.
OVERWRITTEN AND NEWS FROM MEDICINE
The medically rotatedestrant Roche fell short of the primary goal of improving how long patients live without their cancer getting worse, the Swiss pharmaceutical giant reported on Monday in its first-quarter 2022 financial results release. The data Overall patient survival data from the phase 2 study are not yet available. Roche said the study results were presented at a medical meeting later this year.
Giredestrant is a Selective Estrogen Receptor Degrader (SERD). The estrogen receptor (ER) is the main driver of hormone-positive cancer, which is the most common type of cancer. Results reported Monday from a Phase 2 study that enrolled about 300 patients for ER-positive, HER2-negative cancer that had progressed after one or two previous lines of treatment. Roche medically compared this to my choice of drug fulvestrant, an AstraZeneca drug, or an aromatase inhibitor, an endocrine therapy used to treat cancer in the body.
Fulvestrant has validated the ER degradation approach as a cause to treat ER-positive breast cancers. Although medically he has become a successful seller, the intramuscular injection dosage is painful. Additionally, developers of oral SERDs claim that their small molecules may achieve better efficacy than fulvestrant. The oral SERD class struggles to live up to this claim.
Reviews:- my response read full article Roche breast cancer drug fails in Phase 2 following similar stumble by rival Sanofi.
The disappointing results for girodestrant follow Sanofi's announcement in mid-March that oral SERD, amcenestrant, failed to achieve the primary goal of improving progression-free survival in a phase 1 clinical trial. 2. Meanwhile, elacestrant, an oral SERD developed by Radius Health and licensed to the Menarini Group, to meet the primary focus of phase 3 testing in breast cancer last fall. However, parts of Radius later dropped, with closer examination of the data showing that the positive data was driven by results from a subgroup of patients.
TOM GENTILE, CEO OF SPIRIT AEROSYSTEMS & RICHARD GEPHARDT, CO-FOUNDER OF SOLIDARITUS HEALTH
Roche nominates a subgroup of patients with a potential voice to follow for its oral SERD. Despite the Phase 2 failure, the company said the results are still medically meaningful for patients who do not have cancer based on the benefit of estrogen receptor activity. The company is evaluating it medically as it launches a line of treatment for breast cancer patients, a strategy Sanofi has also declared for survival.
This isn't the first time Roche has faced disappointing data for an oral SERD. In 2014, the pharmaceutical company paid $725 million upfront to acquire Seragon Pharmaceuticals. Three years later, Roche revealed that it had halted Phase 2 development of Seragon's lead oral SERD.
The promise of an oral SERD offering better efficiency continues to attract more and more applicants. Today, Pfizer pledged $1 million to start a partnership with Arvinas, an early-career cancer clinician incentive-based deal based at New Haven, Connecticut-based medical biotech that uses a mechanism called targeted protein degradation. Meanwhile, New York-based Zentalis is in interim testing with an oral SERD candidate, a small molecule called ZN-c5. Additionally, Eli Lilly's Loxo Oncology Unit is in early clinical development with an oral SERD called LY3484356.