Dynavax Reports Interim Data for SD-101 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Advanced Squamous Cell Carcinoma of the Head and Neck
“Results from our Phase 1b/2 trial of SD-101 in combination with KEYTRUDA are promising in head and neck cancer, a condition for which patients typically have a poor prognosis,” said
Highlights from Poster Presentation of HNSCC Data
- Interim data from evaluable patients showed an ORR of 33% (6 out of 18) (38% among patients who received at least one scan on study)
- Well tolerated with no dose limiting toxicities
- No increase in frequency or severity of the treatment-related adverse events that have been reported in clinical studies of KEYTRUDA® as a monotherapy, nor evidence of a unique safety signal for the combination.
- Biomarker analyses showed induced broad immune activity, including increase in CD8 T cells, and Th1 response in the tumor microenvironment, consistent with findings reported in advanced melanoma
Highlights from Abstract of Advanced Melanoma Durability Data
- 86% of initial responses were ongoing after a median of 18 months of follow up in patients that were naïve to anti-PD-1/L1 monotherapy (n=7)
- 2 of 12 evaluable patients with progressive disease on prior anti-PD-1/L1 monotherapy achieved a partial or stable disease response for at least 10.5 months
- Median progression-free survival (PFS), duration of response, and median overall survival have not been reached
- Treatment was well tolerated with no Grade 3 or higher treatment-related AEs in longer term follow up
Details for the poster presentation are as follows:
Durability of responses to the combination of SD-101 and pembrolizumab in advanced metastatic melanoma: Results of a phase Ib, multicenter study
Session Title: Phase I Trials in
Poster Board Number: 22
SD-101 in combination with KEYTRUDA generally was well tolerated. The most common treatment-emergent adverse events were injection site reactions and transient grade 1 to 2 flu-like symptoms, including fever, chills and myalgia.
About MEL-01 (KEYNOTE-184)
The dose-escalation and expansion study of SD-101 in combination with KEYTRUDA includes patients with histologically or cytologically confirmed unresectable Stage IIIc/IV melanoma. The primary endpoints of the trial are MTD and evaluation of the safety of intratumoral SD-101 in combination with KEYTRUDA. In addition, the trial is investigating response as assessed by the investigator according to RECIST v1.1, biomarker assessments and duration of response. Patients previously treated with anti-PD-1 and other immunotherapies are included.
SD-101, the Company's lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide.
Forward Looking Statement
This press release contains "forward-looking" statements, including statements regarding the conduct of clinical trials of SD-101. 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; the results of clinical trials and the impact of those results on the initiation or continuation of subsequent trials and issues arising in the regulatory process; the ability to successfully develop and commercialize SD-101; and whether or not
KEYTRUDA is a registered trademark of
Director, Investor Relations & Corporate Communications
Source: Dynavax Technologies Corporation