Dynavax Reports Data for Phase 1b/2 Trial of SD-101 in Combination with KEYTRUDA® (pembrolizumab) in Advanced Melanoma at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting
Overall Response Rate (
Combination showed Similar Rates of Immune-related Adverse Events as Seen with KEYTRUDA Monotherapy
2mg SD-101 Dose Selected for Phase 3
The company reported results on a total of 69 patients comparing two doses of SD-101, ≤ 2mg (n=30) versus 8mg (n=39) administered by intratumoral injection. These data are being presented in poster and discussion session today at the 2018
“These data provide further evidence of the potential for SD-101 to improve responses in first-line advanced melanoma patients in combination with an anti-PD-1 therapy,” commented
Highlights from Poster Presentation (Abstract #9513)
- Overall response rate (
ORR) of 70% (21 of 30), with a complete response (CR) rate of 17%, for advanced melanoma patients who received the ≤ 2 mg dose of SD-101 in up to four lesions ORRof 38% (15 of 39) in patients who received the 8 mg dose of SD-101 in one lesion
- Durable response in patients who received ≤ 2 mg dose of SD-101 with 74% 6-month progression free survival (PFS) rate
- Observed responses in injected lesion(s) and distant lesions, including visceral metastases in the liver
- Responders included 8 of 10 PD-L1 negative patients in the ≤ 2 mg dose cohort
- 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
Additional details on response rates based on patient characteristics including stage of disease, ECOG score, and PD-L1 status are also included in the poster presentation which can be accessed here.
“We are moving forward with the 2mg dose of SD-101 for our Phase 3 trial which we believe is the optimal dose based on these efficacy, safety and biomarker data showing increased immune activation consistent with the biology of TLR9 activation. We continue to collect and analyze data from this trial to finalize details of the Phase 3 study design,” stated
The details of the poster presentation and discussion session are as follows:
Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced melanoma who are naïve to anti-PD-1 therapy
|Session Title: Melanoma/Skin Cancers|
|Poster Board: 340|
|Poster Session Date/Time: Monday, June 4, 2018, 1:15 PM - 4:45 PM CDT|
|Poster Session Location: McCormick Place South, Hall A, Advanced Disease Poster Section|
|Discussion Session Date/Time: Monday, June 4, 2018, 4:45 PM - 6:00 PM CDT|
|Discussion Session Location: McCormick Place Lakeside Center, Level 4 - E451|
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, planned optimal dosage for the Phase 3 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; 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
1. Ribas A, et al. JAMA. 2016;315(15):1600-1609.
2. Specenier P. Expert Opin Biol Ther. 2017;17(6):765-780.
Director, IR & Corporate Communications
Rachel St. Martin
Source: Dynavax Technologies Corporation