Data from Phase II Study of Palbociclib in Patients with Tumors with CDK4 or CDK6 Amplification: Results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol Z1C

• DOI: 10.1158/1078-0432.c.7611442
• Publication Date: 2025-01-06T08:21:38Z
• Authors: Mark H. O’Hara; Opeyemi Jegede; Mark A. Dickson; Angela M. DeMichele; Richard Piekarz; Robert J. Gray; Victoria Wang; Lisa M. McShane; Lawrence V. Rubin...; David R. Patton; P. Mickey Williams; Stanley R. Hamilton; Adedayo Onitilo; James V. Tricoli; Barbara A. Conley; Carlos L. Arteaga; Lyndsay N. Harris; Peter J. O’Dwyer; Alice P. Chen; Keith T. Flaherty
• Keywords: Palbociclib; Cyclin-dependent kinase 6

<div>AbstractPurpose:<p>Amplification of cyclin-dependent kinase 4 (CDK4) and CDK6 is a feature variety malignancies, preclinical evidence suggests that inhibition CDK4/6 plausible treatment strategy in these tumors. Subprotocol Z1C the NCI-Molecular Analysis for Therapy Choice trial was designed to evaluate inhibitor palbociclib CDK4- or CDK6-amplified tumors.</p>Patients Methods:<p>Patients had solid malignancy lymphoma with progression on at least one systemic therapy advanced disease no standard-of-care available. Tumors ≥7 copies CDK4 were considered amplified molecularly eligible. Enrolled patients treated 125 mg daily days 1 21 28-day cycle. The primary endpoint objective response rate.</p>Results:<p>Forty-three enrolled subprotocol Z1C, 38 deemed eligible, treated, included analyses; 25 centrally confirmed have amplification comprised analysis cohort rate endpoint. Among cohort, patient partial response, stable disease, 16 progressive as best response. Four not evaluable due lack follow-up scans. patients, 10 Partial seen only amplification. Median progression-free survival 2.0 months, median overall 8.8 months.</p>Conclusions:<p>Palbociclib showed limited activity histology-agnostic tumors, although central nervous system tumors may be worthy future investigation.</p></div>