Abemaciclib Brings Marked Increase in Progression Free Survival for Patients with Advanced Dedifferentiated Liposarcoma
An interview with:
Mark A Dickson MD, Medical Oncologist, Associate Attending Physician, Memorial Sloan Kettering Cancer Center, New York, USA
CHICAGO, USA—Patients with recurrent or metastatic dedifferentiated liposarcoma who were treated with abemaciclib lived six times longer without disease progression than those in the placebo group of the phase 3 SARC 041 study reported to the 2026 Annual Meeting of the American Society of Clinical Oncology.
First author Mark A Dickson MD, Medical Oncologist and Associate Attending Physician at Memorial Sloan Kettering Cancer Center in New York, talked about the findings with Audio Journal of Oncology reporter, Peter Goodwin:
AUDIO JOURNAL OF ONCOLOGY; Mark A Dickson MD
IN: [Goodwin]”Peter Goodwin here at the …..
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ASCO 2026 Abstract: LBA 2
SARC041: A phase 3 randomized double-blind study of abemaciclib versus placebo in patients with advanced dedifferentiated liposarcoma.
Mark Dickson
Memorial Sloan Kettering Cancer Center, New York, NY
Background:
Dedifferentiated liposarcoma (DDLS) remains a difficult disease to treat with limited systemic therapy options. Approved drugs offer modest benefit such as trabectedin (median progression-free survival [mPFS] 2.2 months [m]) or eribulin (mPFS 2.0m). The Cyclin-dependent kinase 4 (CDK4) oncogene is ubiquitously amplified in DDLS and is a rational therapeutic target. In single-arm phase 2 studies, treatment with selective CDK4 inhibitors resulted in mPFS 4.2m with palbociclib and mPFS 7.7m with abemaciclib. We hypothesized that treatment with abemaciclib would improve PFS compared to placebo in patients with recurrent or metastatic DDLS.
Methods:
SARC041 was a phase 3 randomized double-blind study of abemaciclib versus placebo. The study was open at 9 academic medical centers in the USA. Eligible patients (pts) had recurrent or metastatic DDLS (purely well-differentiated liposarcoma excluded), progression of disease by RECIST 1.1 in the 6 months prior to study entry, any number of prior systemic therapies, and adequate organ function and performance status. Pts were stratified by prior lines of therapy (0 vs 1 or more) and randomized 1:1 between abemaciclib 200 mg PO twice a day or matching placebo. Scans were every 6 weeks (every 12 weeks after week 36) and pts with progression of disease on placebo could cross over to open label abemaciclib. The primary endpoint was PFS. The design provided 80% power with two-sided 10% significance level to detect a hazard ratio of 0.6 by log-rank test. Secondary endpoints were overall response rate (ORR), PFS and response rate after crossover, and overall survival (OS). Data cutoff was March 1, 2026.
Results:
In total, 108 pts were randomized to receive abemaciclib (n = 54) or placebo (n = 54). Demographic/baseline characteristics were generally similar across treatment arms. Abemaciclib demonstrated a statistically significant improvement in PFS at 9.67m vs placebo at 1.52m (hazard ratio [HR] 0.39; 95% confidence interval [CI], 0.25–0.59; p < 0.001). ORR was 9.3% for abemaciclib vs 0% for placebo (p = 0.057). mOS was not reached with abemaciclib vs 25.45m with placebo (HR 0.55; 95% CI, 0.28–1.07; p = 0.077). mPFS after crossover from placebo to abemaciclib was 3.44m (95% CI 2.66, 6.84). ORR after crossover was 4.3% (95% CI 0.53%, 15%). mOS after crossover was 24.03m (95% CI: 11.7, NA). Grade 3 or higher adverse event rates were similar in both arms (p > 0.99). No new safety signals were observed.
Conclusions:
Abemaciclib demonstrated a statistically significant improvement in PFS vs placebo in pts with dedifferentiated liposarcoma, with an encouraging OS trend. These results support abemaciclib as a new treatment option for dedifferentiated liposarcoma.
First Author & Presenter
Mark A. Dickson, MD
J Clin Oncol 44, 2026 (suppl 17; abstr LBA2)
260615 Mark A Dickson ASCO 2026 A J Oncology TEXT
