New results from ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study demonstrated that single-agent palbociclib has no meaningful clinical activity in patients with CDKN2A-mutated or -deleted advanced pancreatic adenocarcinoma and cholangiocarcinoma.
The results, based on data from two cohorts of patients with pancreatic and biliary cancers with CDKN2A loss or mutation treated with palbociclib, were published in JCO Precision Oncology.1
The TAPUR Study identifies signals of antitumor activity of commercially available targeted agents in patients with advanced cancers that harbor genomic alterations that may be targets for already-available drugs. Study participants are enrolled in cohorts based on their tumor type (eg, an advanced solid tumor), 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.
The results, based on the responses of the two cohorts in the article, showed that palbociclib monotherapy does not have clinical activity in patients with advanced pancreatic or biliary cancers with CDKN2A loss or mutation and toxicity was similar to reported experience with palbociclib in other tumor types. These cohorts have been permanently closed.
There are currently 119 TAPUR Study sites in 22 states and nearly 1,600 participants who have received a therapy through the trial.
The TAPUR Study is registered on ClinicalTrials.gov (identifier: NCT02693535), which includes a list of inclusion/exclusion criteria and other information. The TAPUR Study website (tapur.org) has information for patients, such as general eligibility criteria and participating clinical sites, as well as for researchers and practices interested in participating. The website also has contact information for the study team. ■
© 2019. American Society of Clinical Oncology. All rights reserved.
1. Al Baghdadi T, Halabi S, Garrett-Mayer E, et al: Palbociclib in patients with pancreatic and biliary cancer with CDKN2A alterations: Results from the Targeted Agent and Profiling Utilization Registry Study. JCO Precision Oncology. August 14, 2019 (early release online).