Dynavax Provides New Durability of Response Data for SD-101 in Combination with KEYTRUDA® (pembrolizumab) in Melanoma at the...
April 17 2018 - 9:07AM
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
Dynavax Technologies Corporation (NASDAQ:DVAX) today presented
durability of response data in advanced melanoma patients 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). Data were presented in a poster session
at the 2018 American Association for Cancer Research (AACR) Annual
Meeting and show that the combination resulted in an ongoing
response rate of 86 percent at a median follow-up of 18 months for
patients who were naïve to anti-PD-1/L1 treatment. The full poster
presentation can be accessed at
http://investors.dynavax.com/events-presentations.
“We are encouraged by the review of the safety, durability, and
anti-tumor response in this initial group of patients,” said Eddie
Gray, Chief Executive Officer of Dynavax. “These preliminary
results suggest that not only is this combination generating immune
activity in the injected tumors, but that we can also induce an
immune response to tumors at distant sites. These findings, coupled
with our recently reported head and neck data provide further
support for our plans to expand our clinical program into multiple
tumor types in combination with a range of modalities.”
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. 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.
About Dynavax
Dynavax 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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