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The prognosis for recurrent and metastatic squamous cell carcinoma (HNSCC) was poor until the advent of immune checkpoint inhibitors, particularly PD-1 antibodies
.
Median overall survival was approximately 10 months with platinum, 5-fluorouracil, and cetuximab as standard first-line therapy, but more than 80% of patients experienced grade 3 or higher treatment-related adverse events
immunity
SD-101 is a synthetic Toll-like receptor 9 agonist that stimulates human plasmacytoid dendritic cells to release IFNa and mature into highly efficient antigen-presenting cells, enhancing innate and adaptive immune responses
.
This study aimed to investigate whether SD-101 could enhance the anti-tumor activity of anti-PD-1 antibodies in anti-PD-1/PD-L1-naïve patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)
.
Anti-PD-1/PD-L1-naïve patients with recurrent/metastatic head and neck squamous cell carcinoma received weekly injections of SD-101 (2 mg into 1-4 lesions, or 8 mg into one lesion; After 4 times, it will be changed to once every 3 weeks, and then 7 times)
.
In addition, pembrolizumab 200 mg every 3 weeks
A total of 28 patients received 2 mg SD-101 and 23 patients received 8 mg SD-101
.
Overall, 76% of patients had previous systemic therapy
clinical prognosis
clinical prognosisTwelve patients experienced grade ≥3 treatment-related adverse reactions (24%), but no treatment-related deaths
.
The objective response rate was 24%, including two complete responses and 10 partial responses
The objective response rate was 24%, including two complete responses and 10 partial responses
Adverse reactions
Adverse reactionsHPV-positive patients had the highest response rate (44%, n=16)
.
There was no significant correlation between remission and baseline PD-L1 expression level and IFNγ-related gene expression
HPV-positive patients had the highest response rate (44%, n=16) HPV-positive patients had the highest response rate (44%, n=16)
In conclusion, SD-101 combined with pembrolizumab induces objective responses in PD-1 antibody-naïve patients with recurrent/metastatic squamous cell carcinoma , especially HPV-positive tumors
SD-101 combined with pembrolizumab can induce PD-1 antibody-naïve patients with recurrent/metastatic squamous cell carcinoma achieve objective response SD-101 combined with pembrolizumab can induce PD-1 antibody- naïve relapse/metastatic Objective response in patients with metastatic squamous cell carcinoma
Original source:
Original source:Ezra EW Cohen, Lisle Nabell, Deborah J.
Intralesional SD-101 in Combination with Pembrolizumab in Anti-PD-1 Treatment-Na?ve Head and Neck Squamous Cell Carcinoma: Results from a Multicenter, Phase II Trial
