Dynavax’s SD-101 in Combination with KEYTRUDA® (pembrolizumab) Continues to Show a 70% Overall Response Rate in Advanced Melanoma Patients According to Data Presented Today at the ESMO 2018 Congress
- 70% overall response rate (33/47 patients) at 2 mg dose of SD-101 includes 17 additional patients -
-Progression free survival, response rate in patients with PDL-1 negative tumors and biomarker activity supports clinical impact of SD-101’s activity-
- Conference call and webcast to review all
The company reported results on a total of 87 patients (Intention to Treat population) comparing two different doses of SD-101. In the study, 47 patients received ≤2mg of SD-101 in 1-4 lesions and 40 patients received 8 mg in a single lesion. The primary endpoints of this dose-expansion/dose-finding study are safety and preliminary efficacy. The results showed a 70% overall response rate (ORR) in advanced melanoma patients naïve to anti-PD-1/L1 therapy who received the ≤ 2 mg dose of SD-101 and a 48% ORR in the group receiving the 8 mg dose of SD-101. The combination of SD-101 and KEYTRUDA remains well tolerated with adverse events related to SD-101 being transient, mild to moderate flu-like symptoms.
“These results are encouraging because the overall response rate in the 2 mg group has remained consistent with the data presented at the 2018
Highlights from the poster presentation (LBA45)
- ORR of 70% (33 of 47), for advanced melanoma patients who received the ≤ 2 mg dose of SD-101 per lesion
- Durable response in patients who received ≤ 2 mg dose of SD-101 with 85% 6-month progression-free survival (PFS) rate
- Median PFS not reached in patients who received ≤ 2 mg dose of SD-101 with a lower bound of the 95% confidence interval suggesting a minimum ongoing PFS of 15.2 months
- Observed responses in injected lesion(s) and non-injected distant lesions, including visceral metastases in the liver and lung
- Response rates appeared similar regardless of PD-L-1 status
- AEs related to SD-101 treatment were transient, mild to moderate flu-like symptoms at both the ≤ 2mg and the 8 mg dosing levels
- No increase in the frequency of immune-related adverse events over individual monotherapies reported in other studies1,2 nor evidence of any new safety signals
Dynavax Conference Call and Webcast
About SYNERGY-001 (KEYNOTE-184)
SYNERGY-001, previously referred to as MEL-01, is the dose-escalation and expansion study of SD-101 in combination with KEYTRUDA which includes patients with histologically or cytologically confirmed unresectable Stage IIIC/IV melanoma. The primary endpoints of the trial are safety and preliminary efficacy of intratumoral SD-101 in combination with KEYTRUDA.
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, including results from 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; 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
1. Ribas A, et al. JAMA. 2016;315(15):1600-1609.
2. Specenier P. Expert Opin Biol Ther. 2017;17(6):765-780.
|Ryan Spencer||Rachel St. Martin|
|VP Corporate Strategy and Communications||W2O|
Source: Dynavax Technologies Corporation