New results from ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) study have demonstrated that single-agent palbociclib has no meaningful clinical activity in patients with CDKN2A-mutated or -deleted advanced pancreatic adenocarcinoma and cholangiocarcinoma. These findings were published by Baghdadi et al in JCO Precision Oncology.
Findings
The results were based on data from two cohorts of patients with pancreatic (n = 12) and biliary (n = 10) cancers with CDKN2A loss or mutation treated with palbociclib. Patients were treated with standard doses (125 mg/day for 21 days, followed by 7 days off treatment per each 28-day cycle) until disease progression. Radiographic tumor evaluations were performed at 8 and 16 weeks after initiation of treatment. Twenty evaluable patients were included in the analysis.
“Palbociclib monotherapy does not have clinical activity in patients with advanced pancreatic or biliary cancers with CDKN2A loss or mutation. Toxicity is similar to reported experience with palbociclib in other tumor types.”— Baghdadi et al
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No patients had objective response or stable disease at 16 weeks, and as such, both cohorts have been permanently closed. Patients in the pancreatic cancer cohort had a median progression-free survival of 7.2 weeks and a median overall survival of 12.4 weeks, and patients in the biliary cancer cohort had a median progression-free survival of 7.3 weeks and a median overall survival of 11.1 weeks.
The investigators concluded, “Palbociclib monotherapy does not have clinical activity in patients with advanced pancreatic or biliary cancers with CDKN2A loss or mutation. Toxicity is similar to reported experience with palbociclib in other tumor types.”
More About TAPUR
The TAPUR study identifies signals of antitumor activity of commercially available targeted agents in patients with advanced cancers that harbor genomic alterations known as drug targets. Study participants are enrolled in cohorts based on their tumor type, the genomic alterations of their tumors, and the targeted drug(s) that correspond to those alterations in the TAPUR study protocol.
Participants are enrolled in two stages and monitored for treatment response. Patient cohorts are either permanently closed after stage I (less than two responses in 10 participants) or expanded to stage II for further study and confirmation of a signal of drug activity.
Disclosures: For full disclosures of the study authors, visit po.ascopubs.org.
