What's Happening?
Genentech has announced positive results from its Phase III evERA study, which evaluated the investigational drug giredestrant in combination with everolimus for treating estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer. The study met its co-primary endpoints, demonstrating significant improvement in progression-free survival in both the intention-to-treat and ESR1-mutated populations compared to standard-of-care endocrine therapy plus everolimus. The combination was well tolerated, with adverse events consistent with known safety profiles and no new safety signals observed. This marks the first positive head-to-head Phase III trial investigating an all-oral selective estrogen receptor degrader-containing regimen versus a standard of care combination.
Why It's Important?
The results of the evERA study are significant as they offer a potential new treatment option for patients with ER-positive breast cancer, which accounts for approximately 70% of breast cancer cases. This type of cancer is challenging to treat due to its biological complexity and resistance to endocrine therapies, especially after treatment with CDK inhibitors. The giredestrant combination targets two different signaling pathways, potentially improving patient outcomes and minimizing treatment impact by offering an all-oral regimen. The study's success could lead to regulatory approval, providing a new therapeutic option for patients with advanced ER-positive breast cancer.
What's Next?
Genentech plans to present the data at an upcoming medical meeting and share it with health authorities. The company aims to discuss the results with regulatory authorities to make the giredestrant-based regimen available to patients with advanced ER-positive breast cancer. The follow-up for overall survival data continues, with the next analysis scheduled. The extensive clinical development program for giredestrant spans multiple treatment settings and lines of therapy, reflecting Genentech's commitment to delivering innovative medicines to as many people with ER-positive breast cancer as possible.
