Palbociclib (P) in patients (Pts) with pancreatic cancer (PC) and gallbladder or bile duct cancer (GBC) with CDKN2A alterations: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) study.


Details

Authors

person
Tareq Al Baghdadi

Michigan Cancer Research Consortium, Ypsilanti, MI

Tareq Al Baghdadi , Susan Halabi , Elizabeth Garrett-Mayer , Pam K. Mangat , Eugene R Ahn , Vaibhav Sahai , Ricardo H. Alvarez , Edward S. Kim , Kathleen J Yost , Kuo Guo , Andrew Lawrence Rygiel , Kaitlyn R. Antonelli , Nicole L. Butler , Suanna S. Bruinooge , Richard L. Schilsky

Organizations

Michigan Cancer Research Consortium, Ypsilanti, MI, Duke University Medical Center, Durham, NC, American Society of Clinical Oncology, Alexandria, VA, Cancer Treatment Centers of America, Chicago, IL, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, Cancer Treatment Centers of America, Newnan, GA, Carolinas HealthCare System, Charlotte, NC, Cancer Research Consortium of West Michigan, Grand Rapids, MI

Abstract Disclosures

Research Funding

Pharmaceutical/Biotech Company

Background: The TAPUR Study is a phase II multi‐basket study that evaluates the anti‐tumor activity of commercially available targeted agents in pts with advanced cancers with genomic alterations known to be drug targets. Results in two cohorts of PC and GBC pts each with CDKN2A loss or mutation treated with P are reported. Methods: Simon’s optimal two stage design was used to test the null hypothesis of 15% response rate versus the alternative of 35%. Power and alpha were set at 85% and 10%, respectively. Response was assessed per RECIST v1.1. This design requires 10 pts in stage 1 and if < 2 pts have objective response (OR) or stable disease (SD) at 16‐weeks (wks), the cohort is closed. Secondary endpoints are progression‐free survival (PFS), overall survival (OS) and safety. Genomic testing was performed using commercially available tests selected by clinical sites. Treatment was determined according to protocol matching rules based on pre‐defined genomic inclusion criteria. Results: Twelve pts were enrolled in the PC cohort from July 2016 to April 2017, but 2 were subsequently found to be ineligible due to minor deviations from inclusion criteria. Ten pts were enrolled in the GBC cohort from August 2016 to November 2017. All pts are included in the data analysis for demographics, safety, PFS and OS (Table 1). No ORs or SD at 16 wks were observed in the PC or GBC pts and both cohorts were therefore closed. The most common toxicity from P was thrombocytopenia. Conclusions: Monotherapy with P does not have clinical activity in PC or GBC pts with CDKN2A loss or mutation. Toxicity is similar to previous experience with P. These pts should be offered other treatments, including clinical trials. Clinical trial information: NCT02693535

Baseline demographics, clinical characteristics and outcomes by cohort.

Palbociclib targeting CDKN2A
Tumor TypePC (N = 12)GBC (N = 10)
Median age, yrs (range)62 (52, 70)63 (54, 81)
Male%6750
ECOG Performance Status, %2510
0
16760
2830
Median PFS, wks (90% CI)7.2 (4.0, 8.0)7.4 (4.0, 8.4)
Median OS, wks (90% CI)12.4 (4.7, 23.1)11.9 (5.1, 14.0)
Drug‐related AEs, grades 3‐4 (% of pts)840

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