SynDevRx to present interim AMELIA-1 breast cancer data at ESMO 2026

SynDevRx will present interim metabolic and biomarker findings from its AMELIA-1 trial at the ESMO Congress 2026 in Madrid. The data will examine whether evexomostat can help manage hyperglycemia and insulin resistance while supporting capivasertib plus fulvestrant in advanced HR+/HER2- breast cancer.

Why it matters: - The AMELIA-1 data could show whether evexomostat helps patients stay on capivasertib plus fulvestrant longer by easing treatment-related metabolic toxicity. - Hyperglycemia and insulin resistance can limit tolerability, dose intensity and treatment duration for PI3K/AKT pathway-targeted therapy. - If the findings hold up, evexomostat could support broader development of a metabolic adjunct for oncology regimens that disrupt glucose control.

What happened: - SynDevRx said interim biomarker data from its ongoing AMELIA-1 trial will be presented as poster 1862P at the European Society for Medical Oncology Congress 2026 in Madrid. - The poster, titled "Evexomostat plus capivasertib and fulvestrant in PI3K/AKT pathway-altered HR+/HER2- metastatic breast cancer: interim metabolic biomarker findings from the AMELIA-1 trial," is scheduled for Saturday, Oct. 24, at 12:00 p.m. CEST. - The presenter is Dr. Reshma Mahtani, chief of breast medical oncology at Baptist Health Wertheim Cancer Institute in Miami.

The details: - AMELIA-1 is a Phase 1b/2 proof-of-concept study of evexomostat plus capivasertib and fulvestrant in PI3K/AKT/mTOR pathway-altered metastatic breast cancer. - The trial is enrolling patients whose disease progressed after CDK4/6 inhibitor treatment. - Patients with controlled type 2 diabetes are eligible if HbA1c is below 8%. - The poster will report interim data from safety run-in cohorts at evexomostat doses of 36 and 49 mg/m2. - The analysis includes up to 22 patients total, depending on the dataset. - Biomarkers under review include glucose levels, insulin resistance, adipose tissue-derived inflammatory and metabolic markers, cardiovascular biomarkers, weight changes and tumor-associated biomarkers. - SynDevRx is evaluating whether evexomostat can extend the duration of capivasertib plus fulvestrant treatment. - The study is also designed to assess evexomostat’s potential to address resistance to PI3K/AKT inhibitor therapy and reduce hyperglycemia and hyperinsulinemia linked to PI3K/AKT/mTOR inhibitors. - The trial is intended to help establish evexomostat dose and schedule in combination with PI3K/AKT/mTOR inhibitors and fulvestrant for later studies.

Between the lines: - The company is positioning evexomostat as a complementary agent, not a replacement, for pathway-targeted breast cancer therapy. - Dr. Mahtani said the clinical importance of maintaining insulin sensitivity is becoming clearer for oncologists treating patients on PI3K/AKT pathway regimens. - Her comments suggest the value proposition for evexomostat is as much about treatment tolerability as tumor control. - The release frames the work around a broader problem in oncology: metabolic side effects can interfere with the use of effective targeted drugs.

What's next: - SynDevRx will present the interim findings at ESMO 2026 in Madrid. - The company said AMELIA-1 remains ongoing and will continue to inform future clinical trials. - SynDevRx also continues to test evexomostat in metastatic triple-negative breast cancer and aggressive-variant prostate cancer. - Interim data may change as the study continues.

The bottom line: - SynDevRx is betting that a metabolic drug can make a targeted breast cancer regimen easier to tolerate and potentially more durable. The ESMO presentation will be an early test of that idea.