Abemaciclib (Verzenio) has shown the first positive phase 3 trial result in advanced or metastatic dedifferentiated liposarcoma (DDLS), according to the SARC041 study. The oral CDK4/6 inhibitor significantly delayed disease progression compared with placebo in a cancer type with very limited treatment options.
The trial enrolled 108 patients with progressive, recurrent, or metastatic DDLS randomized to abemaciclib or placebo. Median progression-free survival was 9.7 months with abemaciclib versus 1.5 months with placebo, representing a 62% reduction in the risk of progression or death. First-line use showed the strongest benefit, with progression-free survival reaching 16.4 months. The 6-month progression-free survival rate was 60% compared with 22% for placebo.
Although tumor shrinkage was limited, the drug primarily stabilized disease. Overall survival data remain immature, with most placebo patients crossing over to receive abemaciclib. Side effects were consistent with known CDK4/6 inhibitor toxicity, including diarrhea, anemia, and blood count abnormalities.