Dynavax Provides New Durability of Response Data for SD-101 in Combination with KEYTRUDA® (pembrolizumab) in Melanoma at the 2018 American Association for Cancer Research Annual Meeting
Demonstrates potential to achieve long-term, systemic responses
Combination therapy was well tolerated
Additional SD-101 data in head and neck squamous cell carcinoma presented at AACR
“We are encouraged by the review of the safety, durability, and anti-tumor response in this initial group of patients,” said
Highlights from Poster Presentation of Advanced Melanoma Durability Data
- 86% (6 out of 7) of initial responses in advanced melanoma patients naïve to anti-PD-1/L1 treatment were ongoing after a median of 18 months of follow up
- 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
- Well-tolerated and showed no increase in the frequency of immune-related adverse events over individual monotherapies, nor evidence of a unique safety signal
- The most common treatment-related adverse events were injection site reactions and transient mild-to-moderate flu-like symptoms, including fever, chills and myalgia
- Median progression-free survival (PFS), duration of response, and overall survival in naïve patients have not been reached
- Responses were observed in the injected lesion and in distant lesions, including visceral metastases in the lung
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 endpoint of the trial is 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.
About SD-101
SD-101, the Company's lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide.
About
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
Contact:
Director, Investor Relations & Corporate Communications
510.665.7269
dburke@dynavax.com
Source: Dynavax Technologies Corporation