Stephen K.L. Chia, MD, FRCPC, presented findings from the phase III CCTG/BCT MA.40/FINER trial at the 2025 ASCO Annual Meeting. The study focused on advanced HER2-negative, ER-positive breast cancer patients who had progressed on first-line CDK 4/6 and aromatase inhibitors. The trial aimed to improve progression-free survival in the second-line setting by evaluating the efficacy of fulvestrant and ipatasertib in this patient population.
The rationale behind the trial stemmed from the development of resistance mechanisms to standard endocrine therapies like aromatase inhibitors and CDK4/6 inhibitors. The study enrolled 250 patients from various sites in Canada, Australia, and New Zealand, with a specific focus on identifying optimal second-line therapy for this patient cohort. Notably, the trial incorporated the detection of alterations in the PI3 kinase, AKT, or PTEN pathways using ctDNA methodology.
Over a span of three years, the trial enrolled predominantly postmenopausal patients, including a small number of men. A significant proportion of the participants presented with de novo metastatic disease or bony metastases. The ctDNA analysis revealed pathway alterations in 44% of the population, highlighting the potential for targeted treatment strategies in this subset of patients.
The primary endpoint of the study was to assess progression-free survival, with a planned hazard ratio of 0.6. The results demonstrated a statistical improvement in progression-free survival, with a median progression-free survival of approximately 5.3 months in the ipatasertib arm compared to under two months in the control arm. The study also showed a significant improvement in progression-free survival in the AKT-altered cohort, further supporting the efficacy of this treatment approach.
Regarding safety, the toxicity profile associated with ipatasertib primarily included gastrointestinal side effects, with a notable incidence of grade 1 to 3 diarrhea among patients. Other common adverse events included nausea, vomiting, stomatitis, and fatigue. The study’s outcomes not only met the primary endpoint of improving progression-free survival but also provided insights into the potential of AKT inhibitors as a viable treatment option for patients who have progressed on standard therapies.
Dr. Chia’s presentation underscored the importance of exploring targeted therapies in advanced breast cancer and highlighted the role of AKT inhibitors in overcoming resistance mechanisms. The study’s success in improving progression-free survival opens up avenues for further research into combination therapies and the development of additional treatment options for this patient population.
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