AstraZeneca (AZN.L, AZN.ST) announced on Sept. 11 that its Serena-4 phase 3 trial evaluating an Etcamah, or camizestrant, combination therapy failed to achieve its primary endpoint.
The medication combined with palbociclib failed to show significant improvement in progression-free survival in patients with ER-positive, HER2-negative advanced breast cancer. However, the study, which evaluated the Etcamah combination against a treatment including the aromatase inhibitor anastrozole and palbociclib, showed numerical improvement in upfront first-line treatment, alongside a safety profile consistent with each drug individually.
"Whilst we are disappointed by the SERENA-4 outcome, it sharpens our focus on maximising the number of patients who can benefit from Etcamah today based on SERENA-6 and reinforces the importance of ESR1 testing for patients on first-line therapy. Early breast cancer represents an important opportunity, and we remain confident in the long-term potential of Etcamah in the early setting as we advance our broader programme," said Susan Galbraith, executive vice president for oncology hematology research and development at AstraZeneca.
Based on positive Serena-6 phase 3 trial results, regulators in the US, the European Union, Japan and other countries have approved Etcamah combined with a cyclin-dependent kinase 4 and 6 inhibitor for adults whose HR-positive, HER2-negative advanced breast cancer developed an ESR1 gene mutation. AstraZeneca is also evaluating the therapy across the "most comprehensive" oral selective estrogen receptor degrader clinical program focused on early-stage breast cancer.
Meanwhile, updated long-term exploratory results released on Monday for the company's late-stage Adaura study demonstrated that Tagrisso sustained a meaningful overall survival advantage eight years after complete tumor resection in patients with early-stage epidermal growth factor receptor-mutated non-small cell lung cancer, or EGFRm NSCLC. Administered as an adjuvant therapy following surgery, the treatment reduced the risk of death by 47% compared with placebo in patients with stage II through IIIA EGFRm NSCLC.
Against this backdrop, AstraZeneca's shares were nearly 2% higher during midmorning Monday trading in London and over 2% in the green in Stockholm.



