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Ref Type Journal Article
PMID (39413339)
Authors Worden FP, Pisick E, Rothe M, Mangat PK, Garrett-Mayer E, Khalil MF, Carrizosa DR, Bauman JR, Leidner RS, Duvivier HL, Fu S, Park MS, Yost KJ, Calfa CJ, Marr AS, Balmanoukian AS, Behl D, Cannon TL, Nabell L, Powell SF, Thota R, Hinshaw DC, Gregory A, Grantham GN, Halabi S, Schilsky RL
Title Palbociclib in Patients With Head and Neck Cancer and Other Tumors With CDKN2A Alterations: Results From the Targeted Agent and Profiling Utilization Registry Study.
Journal Vol Issue Date Pages Journal Short Title
JCO precision oncology 8 2024 Oct e2400477 JCO Precis Oncol
URL
Abstract Text Targeted Agent and Profiling Utilization Registry is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and targetable genomic alterations. Two cohorts of patients with cyclin-dependent kinase inhibitor 2A (CDKN2A)-mutated tumors treated with palbociclib are reported: one with head and neck cancer (HNC) with both squamous and nonsquamous cell histologies, and one with histology-pooled (HP) cancers.Eligible patients had measurable disease, Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, and no standard treatment options. The primary end point was disease control (DC), defined as objective response (OR) or stable disease (SD) of at least 16+ weeks duration. For the HNC cohort, Simon's two-stage design with a null DC rate of 15% versus 35% (power = 0.85; α = .10) was used. For the HP cohort, the null hypothesis of a DC rate of 15% was rejected if the lower limit of a one-sided 90% CI was >15%. Secondary end points included OR, safety, progression-free survival, overall survival, duration of response, and duration of SD.Seventy patients with HNC (N = 28) or HP cancers (N = 42) were treated with palbociclib. For the HNC cohort, DC and OR rates were 40% (one-sided 90% CI, 27 to 100) and 4% (95% CI, <1 to 18), respectively. The null hypothesis was rejected (P = .002). For the HP cohort, DC and OR rates were 13% (one-sided 90% CI, 6 to 100) and 5% (95% CI, <1 to 17), respectively. The null hypothesis was not rejected. Thirty-one of 70 patients experienced treatment-related grade 3 to 4 adverse events (AEs) or serious AEs, the most common including neutropenia, thrombocytopenia, and leukopenia.Palbociclib met prespecified criteria to declare a signal of activity in patients with HNC with CDKN2A alterations, but not in the HP cohort.

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
CDKN2A L62_E69del deletion unknown CDKN2A L62_E69del results in the deletion of eight amino acids in ANK repeat 2 of the Cdkn2a protein from amino acids 62 to 69 (UniProt.org). L62_E69del has been identified in the scientific literature (PMID: 39413339), but has not been biochemically characterized and therefore, its effect on Cdkn2a protein function is unknown (PubMed, Aug 2025).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
CDKN2A mutant head and neck cancer sensitive Palbociclib Phase II Actionable In a Phase II trial (TAPUR), Ibrance (palbociclib) treatment led to a disease control rate (DCR) of 40% (11/28), objective response rate (ORR) of 4% (1/28, 1 partial response), median progression-free survival (mPFS) of 11 weeks and median overall survival (mOS) of 42 weeks in patients with heavily pretreated head and neck cancer harboring CDKN2A alterations, and a DCR of 13% (5/40), ORR of 5% (2/40), mPFS of 8 weeks, and mOS of 26 weeks in patients with advanced solid tumors (PMID: 39413339; NCT02693535). 39413339
CDKN2A loss head and neck cancer sensitive Palbociclib Phase II Actionable In a Phase II trial (TAPUR), Ibrance (palbociclib) treatment led to a disease control rate (DCR) of 40% (11/28), objective response rate (ORR) of 4% (1/28, 1 partial response), median progression-free survival (mPFS) of 11 weeks and median overall survival (mOS) of 42 weeks in patients with heavily pretreated head and neck cancer harboring CDKN2A alterations, and a DCR of 13% (5/40), ORR of 5% (2/40), mPFS of 8 weeks, and mOS of 26 weeks in patients with advanced solid tumors (PMID: 39413339; NCT02693535). 39413339