Palbociclib Active in CDKN2A-Altered Ovarian Cancer
By: Lisa Astor
Posted: Monday, August 31, 2026
Palbociclib demonstrated modest activity in patients with ovarian cancer and a CDKN2A alteration, according to findings from a cohort of the Targeted Agent and Profiling Utilization Registry (TAPUR) study. The results, published in JCO Precision Oncology, met the prespecified criteria to declare activity for palbociclib in this patient population.
“Although the sample size is small, results from this study align with prior trials of patients with ovarian cancer, suggesting CDK4/6 inhibitors have the highest efficacy in patients with low-grade serous ovarian cancer,” wrote the study authors, including corresponding author Dominique C. Hinshaw, PhD, of the American Society of Clinical Oncology.
The cohort enrolled 28 patients with advanced ovarian cancer, an ECOG performance status between 0 and 2, a CDKN2A alteration (loss, n = 21; mutation, n = 5; loss and mutation, n = 2), and no remaining standard treatment options. The primary endpoint was disease control, defined as objective response or stable disease for at least 16 weeks. The cohort had a null disease control rate of 15% vs 35% (power = 0.85). One patient was not evaluable in the efficacy analysis due to an excluded genomic finding.
Disease control was achieved in 38% (90% confidence interval [CI] = 25%–100%) and the objective response rate was 11% (95% CI = 2%–29%). The median duration of disease control was 30 weeks (range = 16–78 weeks). The null hypothesis of 15% disease control was rejected (P = .004). The median progression-free survival was 8 weeks (95% CI = 8–18) and the median overall survival was 33 weeks (95% CI = 24–73).
Sixty-eight percent of patients experienced at least one grade 3/4 treatment-related adverse event or serious event, with the most common being anemia, dyspnea, fatigue, leukopenia, neutropenia, and thrombocytopenia. No grade 5 events were reported.
