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A phase II study of poziotinib in patients with recurrent and/or metastatic head and neck squamous cell carcinoma

 Ji Hyun Lee  ;  Seong Gu Heo  ;  Beung-Chul Ahn  ;  Min Hee Hong  ;  Byoung Chul Cho  ;  Sun Min Lim  ;  Hye Ryun Kim 
 CANCER MEDICINE, Vol.10(20) : 7012-7020, 2021-07 
Journal Title
Issue Date
biomarker ; head and neck cancer ; poziotinib
Background: In phase I studies, poziotinib has shown meaningful efficacy against various types of cancers. This phase 2 study aimed to investigate the efficacy and safety of poziotinib in recurrent and/or metastatic head and neck squamous cell carcinoma (R/M-HNSCC).

Methods: Overall, 49 patients were enrolled (median age, 62 years; age range, 21-78 years). Patients received a median of two prior treatments including chemotherapy and others and received 12 mg poziotinib orally once daily as part of a 28-day cycle. The primary endpoint was objective response rate (ORR), and the secondary endpoints were progression-free survival (PFS) and overall survival (OS). Targeted capture sequencing was performed using available tissues to identify translational biomarkers related to clinical response.

Results: ORR was 22.4%, median PFS was 4.0 months (95% confidence interval [CI], 1.8-6.2 months), and median OS was 7.6 months (95% CI, 4.4-10.8 months). The most common treatment-related adverse events were acneiform rash (85%) and mucositis (77%). A grade 3 or higher adverse event was acneiform rash (3%). Targeted capture sequencing was performed in 30 tissue samples. TP53 and PIK3CA were the most frequently mutated genes (43%), followed by CCND1 (33%) and EGFR (30%). Mutations in ERBB2, ERBB3, and ERBB4, which are HER family genes, were observed in 17%, 13%, and 10% samples, respectively. There was no difference in the frequency of somatic mutations in the HER family genes between the clinically benefitted and non-benefitted groups.

Conclusion: Compared to other pan-HER inhibitors, poziotinib showed clinically meaningful efficacy in heavily treated R/M-HNSCC.

Clinical trial registration number: NCT02216916.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Hye Ryun(김혜련) ORCID logo https://orcid.org/0000-0002-1842-9070
Ahn, Beung-Chul(안병철) ORCID logo https://orcid.org/0000-0002-2579-2791
Lee, Ji Hyun(이지현)
Lim, Sun Min(임선민)
Cho, Byoung Chul(조병철) ORCID logo https://orcid.org/0000-0002-5562-270X
Heo, Seong Gu(허성구)
Hong, Min Hee(홍민희) ORCID logo https://orcid.org/0000-0003-3490-2195
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