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Phase II Trial Shows Activity of Poziotinib in HER2 Exon 20–Mutant NSCLC

By: Victoria Kuhr, BA
Posted: Monday, January 3, 2022

The tyrosine kinase inhibitor poziotinib showed antitumor activity in patients with HER2 exon 20–mutant non–small cell lung cancer (NSCLC), according to Yasir Y. Elamin, MD, of The University of Texas MD Anderson Cancer Center, Houston. Additionally, the authors proposed this new therapeutic option may be used for patients with NSCLC who were previously treated with platinum-based chemotherapy and immunotherapy. A detailed report of the study was published in the Journal of Clinical Oncology. Poziotinib has been granted Fast Track designation for this indication by the U.S. Food and Drug Administration.

“The optimal dosing of poziotinib is being investigated in a randomized study that compares twice daily dosing to once daily dosing,” the investigators commented. “The daily dose of 16 mg used in the current study was associated with significant but manageable toxicity and frequently required dose reduction.”

A total of 30 patients with advanced HER2 exon 20–mutant NSCLC were enrolled into a single-arm, phase II study. These patients received poziotinib at a dose of 16 mg/day for 28-day cycles. Scans were performed at least 28 days after patients’ first radiologic response.

Of the 30 patients enrolled in the study, 90% received poziotinib at a dose of 16 mg/day for 28-day cycles. The median duration of response across HER2 exon 20 mutation subtypes was 5 months (95% confidence interval [CI] = 4 months to not estimable). The median progression-free survival was 5.5 months. The median overall survival was 15 months (95% CI = 9 months to not estimable).

The most common grade 3 treatment-related adverse events were skin rash (47%) and diarrhea (20%). One patient had a possible treatment-related death because of pneumonitis.

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



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