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.

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 2020.1 Approximately 70% of breast cancer tumours are considered HR-positive and HER2-low or negative.2 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.3

Mafalda Oliveira, MD, PhD, Vall d‘Hebron Institute of Oncology in Barcelona, Spain and lead investigator in the SERENA-2 Phase II trial, said: “The results from SERENA-2 show that camizestrant provides a significant improvement in progression-free survival compared to fulvestrant, which has been used to treat patients with HR-positive breast cancer for almost twenty years. These results are meaningful, highlighting the potential of this next-generation oral SERD and supporting the ongoing research program.”

Susan Galbraith, EVP, Oncology R&D, AstraZeneca, said: “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.”