Pharma major AstraZeneca on Wednesday said that its oral drug has met the primary endpoint of demonstrating a statistically significant and clinically meaningful progression-free survival (PFS) in post-menopausal patients with estrogen receptor (ER)-positive locally advanced or metastatic breast cancer. The patients were previously treated with endocrine therapy for advanced disease.
“Positive high-level results from the SERENA-2 Phase II trial showed that AstraZeneca’s next-generation oral selective estrogen receptor degrader (ngSERD) camizestrant met the primary endpoint of demonstrating a statistically significant and clinically meaningful progression-free survival (PFS) benefit at both 75mg and 150mg dose levels versus Faslodex (fulvestrant) 500mg in post-menopausal patients with estrogen receptor (ER)-positive locally advanced or metastatic breast cancer, previously treated with endocrine therapy for advanced disease,” the pharma major said in a statement on Wednesday.
The company claims that Camizestrant was well tolerated, and its safety profile was consistent with that observed in previous trials with no new safety signals identified.
Breast cancer is the most common cancer worldwide, with an estimated 2.3 million patients diagnosed in 2020. Approximately 70 percent of breast cancer tumours are considered HR-positive and HER2-low or negative.
According to the company, Endocrine therapies are widely used for the treatment of HR-positive breast cancer, but many patients with advanced disease develop resistance to 1st-line CDK4/6 inhibitors and estrogen receptor-targeting therapies, underscoring the need for additional options.
“Our goal with our next-generation oral SERD camizestrant is to improve on currently available endocrine therapies for patients with HR-positive breast cancer in early and metastatic disease. The exciting efficacy and compelling safety results from the SERENA-2 trial underscore the potential for camizestrant to achieve this goal in patients with ER-driven breast cancer and we look forward to advancing our comprehensive Phase III clinical programme for camizestrant,” Susan Galbraith, EVP, Oncology R&D, AstraZeneca, said in a statement on Tuesday.
The data will be presented at a forthcoming medical meeting. The company has a comprehensive portfolio of approved and potential new medicines in development for patients with breast cancer. In addition to these results, the Company has also announced today positive results from the CAPitello-291 Phase III trial of capivasertib in HR-positive advanced breast cancer.
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