Dynavax Presents Phase 2 Data on SD-101 in Combination with KEYTRUDA® (pembrolizumab) for Patients with Head and Neck Squamous Cell Carcinoma at the 2019 ASCO Annual Meeting
- 24% overall response rate in ITT population
- Responses were observed in SD-101 injected and non-injected lesions
- The combination of SD-101 and pembrolizumab was well-tolerated
“We are pleased with the results, particularly when we see a 24% response rate in second-line head and neck squamous cell carcinoma, a tumor that has historically low rates of response to anti-PD-1 treatments,” said
In the Phase 1b/2 clinical study (NCT02521870) in patients with recurrent or metastatic HNSCC, SD-101 is administered intratumorally with 8 mg in 1 lesion or 2 mg in 1–4 lesions combined with intravenous administration of 200 mg of pembrolizumab.
Key highlights from the clinical data presentation include:
- An overall response rate (ORR) of 24% (ITT) n = 50 was observed.
- An ORR of 22.2% in the 2 mg cohort and an ORR of 26.1% in the 8 mg cohort were observed.
- An ORR of 33.3% and a disease control rate (DCR) of 41.6% were observed in patients with low PD-L1 status at baseline.
- An ORR of 36% was observed in patients with HPV-positive tumors.
- Biomarker data are consistent with the mechanism of action of SD-101 and demonstrate strong immunomodulation of the tumor microenvironment including infiltration of activated T cells and upregulation of Type I and Type II Interferon (IFN).
- Importantly, similar to what was reported for melanoma patients who had not received anti-PD-1 therapy (
ASCO2019 Abstract 9534), patients whose tumors exhibited an immunologically cold tumor microenvironment at baseline (low IFNγ and T cell signatures) showed clinical response during SD-101 plus pembrolizumab treatment.
- The combination of SD-101 and pembrolizumab was well-tolerated, consistent with previous reports.
- No evidence of an increased incidence or severity of adverse events (AEs) over pembrolizumab monotherapy.
- No increase in immune-related AEs over pembrolizumab monotherapy.
- AEs associated with SD-101 were mainly mild to moderate injection-site reactions and flu-like symptoms that were manageable with over-the-counter medication.
SD-101 is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating SD-101 in several clinical studies to assess its safety and activity, including a Phase 2 study in combination with KEYTRUDA® (pembrolizumab) in advanced melanoma and metastatic or recurrent head and neck squamous cell cancer in collaboration with Merck, and in high risk breast cancer in collaboration with I-SPY 2.
This press release contains "forward-looking" statements, including statements regarding the conduct of clinical trials of SD-101, including results from the Phase 2 cohort expansion of the Phase 1b/2 trial, and potential value of SD-101 across multiple tumor types. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether we can timely provide adequate clinical supplies; initiation, enrollment and completion of clinical trials of SD-101; whether interim and final results of current and future clinical trials will support the initiation or continuation of subsequent trials by us or another party; issues arising in the regulatory process; the ability to successfully develop or pursue strategic alternatives for SD-101, including the funding of future studies, as well as other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended
Heather RoweVice President, Investor Relations & Corporate Communications firstname.lastname@example.org 510-665-7269
Source: Dynavax Technologies Corporation