AstraZeneca is on the brink of a major breakthrough in advanced breast cancer treatment after European regulators backed approval of its next-generation therapy camizestrant in combination with CDK4/6 inhibitors.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the treatment for adults with ER-positive, HER2-negative locally advanced or metastatic breast cancer carrying ESR1 mutations — a move that may reshape first-line care for thousands of patients across Europe.
The recommendation is powered by blockbuster results from the pivotal Phase III SERENA-6 trial.
The data showed the camizestrant combination slashed the risk of disease progression or death by 56% compared with current standard-of-care endocrine therapy. Patients receiving the regimen achieved a median progression-free survival of 16 months, compared with just 9.2 months for those on standard aromatase inhibitor therapy combined with CDK4/6 inhibitors.
Further analysis also showed the treatment extended time to second disease progression to 25.7 months versus 19.1 months, while overall survival data continues to trend in favour of camizestrant.
“This recommendation represents an important step forward for patients with advanced breast cancer in Europe and a milestone in the adoption of new treatment strategies. There is a need for new treatments that delay disease progression in the 1st-line setting, after which the cancer becomes harder to treat, and a patient’s quality of life may decline.
"Through prompt intervention with the camizestrant combination to treat emergence of resistance before it causes disease progression and deterioration of quality of life, we are able to extend the benefit of 1st-line treatment and optimise outcomes,” said François-Clément Bidard, co-principal investigator for the SERENA-6 trial.
The recommendation also marks a major advance in precision oncology, using circulating tumour DNA monitoring to detect endocrine resistance before visible disease progression occurs.
“This decision from the EU’s CHMP is a vote of confidence in SERENA-6, the first pivotal trial to demonstrate the clinical value of monitoring circulating tumour DNA to detect emerging endocrine resistance and guide a change of therapeutic strategy in the 1st-line setting.
"If approved, camizestrant would be the first and only next-generation oral SERD and complete ER antagonist for use in combination with widely approved CDK4/6 inhibitors in this setting, reinforcing the practice-changing potential of this approach to advance patient outcomes and evolve the clinical landscape,” said Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca.
Safety results from the trial remained consistent with the known profiles of camizestrant and the partnered CDK4/6 inhibitors, with no new safety concerns identified and low discontinuation rates reported across both treatment arms.
