On June 4, 2018 Dynavax Technologies Corporation (NASDAQ:DVAX) reported data from its ongoing Phase 1b/2 study investigating SD-101, Dynavax’s intratumoral TLR9 agonist, in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy developed by Merck (known as MSD outside the United States and Canada) in patients with advanced melanoma (Press release, Dynavax Technologies, JUN 4, 2018, View Source [SID1234527166]).
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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 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, in Chicago, IL. The primary endpoints of this dose-expansion/dose-finding study are safety and preliminary efficacy. The results of this study showed a 70% overall response rate (ORR) in advanced melanoma patients who received the £ 2 mg dose of SD-101 in up to four lesions versus a 38% ORR in the group receiving the 8 mg dose of SD-101 in one lesion. The combination of SD-101 and KEYTRUDA was well tolerated with adverse events related to SD-101 being transient, mild to moderate flu-like symptoms.
"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 Eddie Gray, Chief Executive Officer. "Our studies continue to demonstrate the potential value of SD-101 across multiple tumor types. We plan to build upon this momentum and update our progress with additional data planned for a medical conference later in the year."
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
ORR of 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 Rob Janssen, Chief Medical Officer.
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
Abstract: 9513
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
Analyst/Investor Presentation
Today at 6:30pm CDT, Dynavax will host a presentation for analysts and investors. The presentation will be available via live webcast only and can be accessed in the "Investors and Media" section of the company’s website at www.dynavax.com.
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.
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. Dynavax is evaluating this intratumoral TLR9 agonist in several clinical studies to assess its safety and activity, including a Phase 2 study in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, in patients with advanced melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.