Dynavax Reports Interim Data for SD-101 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Advanced Squamous Cel...
April 16 2018 - 2:10PM
Dynavax Technologies Corporation (NASDAQ:DVAX) today announced data
from its ongoing Phase 1b/2 study investigating SD-101, Dynavax's
intratumoral TLR9 agonist, in combination with KEYTRUDA® , an
anti-PD-1 therapy developed by Merck (known as MSD outside the
United States and Canada). These data were presented in a poster
session at the 2018 American Association for Cancer Research (AACR)
Annual Meeting. The results from this dose escalation study
showed encouraging response rates in patients with advanced head
and neck squamous cell carcinoma. In addition, the combination was
well tolerated. The full poster presentation can be accessed at
http://investors.dynavax.com/events-presentations.
“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 Eddie Gray,
Chief Executive Officer of Dynavax. “This is another tumor type in
which SD-101, based on early data, has demonstrated encouraging
activity while being well tolerated. As understanding of
combination therapy matures we believe an effective immune
stimulating agonist with an attractive tolerability profile will
play a significant role in a wide range of tumors.”
“On Tuesday, April 17, 2018 we are also presenting updated data
from our Phase1b/2 study at AACR from a cohort of melanoma
patients, where a durable response was observed in patients naïve
to anti-PD-1/L1 therapy as well as patients with prior treatment.
We are excited about the overall results to date and believe this
underscores the potential breadth of our immuno-oncology platform,”
Mr. Gray added.
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 ProgressAbstract: CT139Poster
Board Number: 22Date/Time: Tuesday Apr 17, 2018 8:00 AM - 12:00 PM
CDTLocation: McCormick Place South, Hall A, Poster
Section 42
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.
About SD-101SD-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 metastatic 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.
About DynavaxDynavax is a fully-integrated
biopharmaceutical company focused on leveraging the power of the
body's innate and adaptive immune responses through toll-like
receptor (TLR) stimulation. Dynavax discovers and develops novel
vaccines and immuno-oncology therapeutics. The Company’s first
commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant),
Adjuvanted], is approved in the United States. Dynavax's lead
immunotherapy product, SD-101, is an investigational cancer
immunotherapeutic currently being evaluated in Phase 1/2 studies
and its second cancer immunotherapeutic, DV281, is in Phase 1
development. For more information, visit www.dynavax.com.
Forward Looking StatementThis 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 Dynavax and
parties with whom we are collaborating may reach any future
agreement on further studies or a more extensive collaboration
beyond the clinical trials contemplated under the existing
agreements, as well as other risks detailed in the "Risk Factors"
section of our current periodic reports with the SEC. We undertake
no obligation to revise or update information herein to reflect
events or circumstances in the future, even if new information
becomes available. Information on Dynavax's website at
www.dynavax.com is not incorporated by reference in our current
periodic reports with the SEC.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc.
Contact:
David BurkeDirector, Investor Relations & Corporate
Communications510.665.7269dburke@dynavax.com
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