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Palbociclib Monotherapy for Advanced NSCLC With CDKN2A Alterations

By: Joseph Fanelli
Posted: Monday, October 12, 2020

In heavily pretreated patients who have non–small cell lung cancer (NSCLC) with CDKN2A gene alterations, monotherapy with the CDK4/6 inhibitor palbociclib may result in antitumor activity, according to findings from the Targeted Agent and Profiling Utilization Registry (TAPUR) study published in JCO Precision Oncology. Richard L. Schilsky, MD, of the American Society of Clinical Oncology, Alexandria, Virginia, and colleagues noted that additional investigation is needed to confirm the therapy's efficacy for this patient population.

“It seems clear from this and other studies that CDK4/6 inhibitors used as single agents have modest antitumor activity in patients with advanced NSCLC,” the authors concluded. “It is not clear, however, that patient selection using CDK4/6 genomic target alterations is a necessary or effective strategy to identify patients most likely to benefit from treatment.”

The authors enrolled 29 patients with advanced NSCLC. The selected patients had no remaining standard treatment options, measurable disease, an Eastern Cooperative Oncology Group performance status of 0 to 2, and adequate organ function. Those with CDKN2A alterations and no Rb mutations received 125 mg of palbociclib once daily for 21 days, followed by 7 days off. Two patients were not evaluable for a response but were included in safety analyses.

The authors observed a disease control rate of 31% among the patients, with one partial response and six patients with stable disease. The median progression-free survival was 8.1 weeks, with a median overall survival of 21.6 weeks.

A total of 11 patients experienced at least one grade 3 or 4 adverse event or serious adverse event possibly related to palbociclib, with the most common event being cytopenia. Other adverse events and serious adverse events possibly related to treatment were anorexia, fatigue, febrile neutropenia, hypophosphatemia, sepsis, and vomiting.

Disclosure: For full disclosure of the study authors, visit ascopubs.org.



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