The prognosis of patients with platinum-refractory head and neck squamous cell carcinoma (HNSCC) was poor. Sintilimab is an immune checkpoint inhibitor. Nab-paclitaxel is a nanoparticle taxane that showed activity in platin-resistant HNSCC. This study aimed to evaluate the efficacy and safety of sintilimab plus nab-paclitaxel in patients with platinum-refractory HNSCC.
This study is a single-arm, open-label, single-center phase II clinical study. Patients with R/M HNSCC who have failed platinum-based therapy were enrolled. All patients were treated with sintilimab(200mg iv d1) and nab-paclitaxel(120mg/m2 iv d1 and d8) every 3 weeks up to 6 cycles and then maintained with sintilimab until disease progression, death, or dose-limiting toxicities. The primary endpoint was the objective response rate (ORR). The secondary endpoints included progression-free survival (PFS), overall survival(OS), and safety.
From April 2019 to April 2022, 15 patients were enrolled. The median age was 55 years (range34-67), and 11 patients were male. Primary site included the oropharynx (1, 6.7%), nasopharynx (6, 40.0%), larynx/hypopharynx (5, 33.3%) and oral cavity (3, 20.0%). Presence of distant metastases(11, 73.3%); prior platinum-based chemotherapy(15, 100%), radiation (11, 73.3%), EGFR targeted therapy (6, 40.0%); ECOG PS =1 (15, 100%); PD-L1 CPS≥10 (6, 40.0%), not applicable (7, 46.7%). The ORR was 20.0% (95% CI, 7.1-45.2%), DCR was 80.0% (95%CI 54.8-92.9%). With a median follow-up time of 12.1 months, 8 patients experienced disease progression, and 5 died. The median PFS was 14.4 (95% CI, 4.0-24.7) months. The median OS was not reached. Common treatment-related adverse events (TRAEs) were hypothyroidism(26.7%), leukopenia(20.0%), pneumonia (20.0%), and nausea (13.3%). Most of the TRAEs were grade 1 or 2. Only one patient experienced grade 3 hypothyroidism.
Sintilimab plus nab-paclitaxel is well-tolerated with very encouraging clinical activity in platinum-refractory HNSCC and warrant further exploration in this disease.
NCT03975270, June 5, 2019.
The authors.
Innovent biologics Inc.
All authors have declared no conflicts of interest.