929P - Pembrolizumab plus nab-paclitaxel and platinum as first-line treatment in patients with with recurrent/ metastatic head and neck squamous-cell carcinoma (R/M SCC) of the nasal cavity and paranasal sinuses

Background

Pembrolizumab plus platinum and fluorouracil is the standard first-line treatment in patients with recurrent/ metastatic head and neck squamous-cell carcinoma (R/M HNSCC). However, there is no relevant data on nasal cavity and paranasal sinuses in KN-048. As the first prospective study of immunotherapy combined with chemotherapy in the treatment of SCC of nasal cavity and paranasal sinuses, it aims to verify its efficacy.

Methods

Patients with untreated R/M SCC of nasal cavity and paranasal sinuses and with ≥1 measurable lesion according to RECIST 1.1 were included. Patients received pembro 200mg, nab-paclitaxel 260mg/m² plus cisplatin 75 mg/m² or carboplatin AUC5 on day 1 every 21 days for up to six cycles followed by pembro maintenance therapy until progression or unacceptable toxicity or 35 cycles, whichever occurred first. The primary endpoint were ORR and PFS. Secondary endpoints were safety, DCR and OS.

Results

From August 26 2021 until March 3 2023, 16 patients were enrolled. The baseline characteristics are shown in the table. 1 patient with SD after 4 cycles of treatment was not treated for COVID-19. The ORR was 50% and 1 (5%) patient was CR (also this patient's CPS<1). The DCR was 100%. Median follow-up was 10.7 months, the median PFS and the median OS were not reached, and median Time of Treatment (TOT) was 7.7 months (2.1-20.3). Currently, only 1 patient who had achieved objective response has shown disease progression, and mTOT was 8.55 months (4.6-20.3). Grade 3 and 4 TRAEs reached 70%, and mainly come from chemotherapy-related neutropenia. 1 patient with grade 3 thrombocytopenia. Thyroid dysfunction is the most common irAEs. There was no TRAEs leading to treatment discontinuation.

Table: 929P

Conclusions

Pembrolizumab plus nab-paclitaxel and platinum shows encouraging antitumor activity accompanied with a manageable side effect profile in untreated R/M SCC of the nasal cavity and paranasal sinuses patients.

Clinical trial identification

This study is registered at Chinese Clinical Trial Registry, number ChiCTR2200057343, and the release date is March 9, 2022.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.