Intralesional SD-101 in Combination with Pembrolizumab in Anti-PD-1 Treatment-Naive Head and Neck Squamous Cell Carcinoma: Results from a Multicenter, Phase II Trial.

ABSTRACT:

Purpose

To determine whether SD-101, a Toll-like receptor 9 agonist, potentiates the antitumor activity of anti-PD-1 antibodies in patients with anti-PD-1/PD-L1 naïve, recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).

Patients and methods

Patients with PD-1 Ab-naïve HNSCC received either 2 mg SD-101 injected in one to four lesions or 8 mg SD-101 injected into a single lesion weekly × 4 doses then every 3 weeks × 7 doses. Pembrolizumab was administered at 200 mg every 3 weeks.

Results

A total of 28 patients received 2 mg and 23 received 8 mg per injection, respectively. A total of 76% of patients had received prior systemic therapy. Combined positive score was ≥1 to < 20 in 35 patients (70%) and ≥ 20 in 15 patients (30%) of 50 patients with available

SUBMITTER: Cohen EEW 

PROVIDER: S-EPMC9365346 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature