William Jacot, MD, PhD, discusses updated efficacy and safety results from the phase 2 AMALEE trial.
William Jacot, MD, PhD, professor, oncology, the University of Montpellier, discusses updated efficacy and safety results from the phase 2 AMALEE trial (NCT03822468).
The AMALEE trial evaluated ribociclib (Kisqali) at doses of 400 mg and 600 mg plus aromatase inhibitors in patients with hormone receptor–positive, HER2-negative advanced breast cancer. The overall response rate (ORR) was lower in the 400 mg arm, at 47.5% vs 55.2% in the 600 mg arm, although the median progression-free survival (PFS) data were similar, at 24.9 months and 25.1 months in the 400 mg and 600 mg arms, respectively, Jacot says.
A key secondary end point of this trial was mitigating the adverse effects (AEs) of ribociclib, including QTcF and neutropenia, through the lower dose of the agent, Jacot explains. The patients who received 400 mg of ribociclib experienced lower corrected QT interval increases and lower rates of neutropenia than those who received 600 mg, Jacot notes. Although ORRs with the 400 mg dose were not noninferior to those with the 600 mg dose, the identical PFS data between the arms and the favorable toxicity profile in the 400 mg arm support the ribociclib dose reduction to partially alleviate AEs, Jacot concludes.