A centre in Taiwan conducted a retrospective study to evaluate the preliminary effectiveness and safety of afatinib* in combination with pembrolizumab in the treatment of patients (n=51) with recurrent or metastatic head and neck squamous cell cancer (HNSCC).1
Eligible patients had cancer of the oral cavity (75%; n=38), oropharynx (12%; n=6) or hypopharynx (14%; n=7).1 Forty-three percent (n=22) had received first-line platinum-based chemotherapy and 57% (n=29) were refractory to platinum-based chemotherapy.1 The majority of patients (84%; n=43) were afatinib naïve; 16% (n=8) had received previous afatinib monotherapy.1
The objective response rate (ORR) in the afatinib-naïve cohort was 56% (95% confidence interval [CI]: 40.8‒70.8%); median duration of response was 7.5 (95% CI: 2.4‒12.6) months.1 The overall survival (OS) rate at 12 months was 59%, and median progression-free survival (PFS) was 6.3 (95% CI: 4.7‒7.9) months.1 In patients who had received previous afatinib monotherapy, ORR was lower (25%) and median PFS shorter (3.3 [95% CI: 0.0‒9.0] months); median OS was 6.4 (95% CI: 4.7‒8.2) months.1
Afatinib dose adjustment was necessary in 71% of patients.1 The most common all-grade adverse events (AEs) were diarrhoea (55%), skin rash (43%) and mucositis (27%). The most common Grade 3/4 AEs were mucositis (4%), skin rash (2%) and pneumonitis (2%).1
The Phase II ALPHA trial (NCT03695510) is ongoing to further investigate afatinib plus pembrolizumab in HNSCC.
Kao H-F, et al. Poster presented at ESMO 2018 (Poster 1062P).
*Afatinib is approved in more than 80 markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF®, in the US under the brand name GILOTRIF® and in India under the brand name Xovoltib®; for the full list, please click here. Registration conditions differ internationally; please refer to locally approved prescribing information. Afatinib is being investigated in head and neck squamous cell carcinoma (HNSCC) and is not approved for this use. The efficacy and safety of afatinib in HNSCC has not been established.
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Page last updated: June 2019
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