Dynavax Presents Phase 2 Data on SD-101 in Combination with KEYTRUDA® (pembrolizumab) for Patients with Head and Neck Squamo...
June 01 2019 - 2:15PM
Dynavax Technologies Corporation (NASDAQ: DVAX), today
announced favorable results from the Phase 2 cohort expansion of
the Phase 1b/2, open-label, multicenter study of intratumoral
SD-101 in combination with KEYTRUDA® (pembrolizumab) in anti-PD-1
treatment-naïve patients with recurrent or metastatic head and neck
squamous cell carcinoma (HNSCC). The results were presented today
in a poster session at the 2019 American Society of Clinical
Oncology (ASCO) Annual Meeting.
“We are pleased with the results, particularly when we see a 24%
response rate in second-line head and neck squamous cell carcinoma,
a tumor that has historically low rates of response to anti-PD-1
treatments,” said Robert Janssen, M.D., chief medical officer of
Dynavax. “When we look at patients with a combined positive PD-L1
score of less than 20%, their rate of response at 29% was similar
to the 25% rate of response for those patients with higher PD-L1
positive scores. Additionally, more than a third of patients with
HPV-positive tumors responded. Further, our biomarker data support
these clinical outcomes and demonstrate that immunologically cold
tumors reach similarly high levels of immune cell infiltration as
immunologically hot tumors.”
In the Phase 1b/2 clinical study (NCT02521870) in patients with
recurrent or metastatic HNSCC, SD-101 is administered
intratumorally with 8 mg in 1 lesion or 2 mg in 1–4 lesions
combined with intravenous administration of 200 mg of
pembrolizumab.
Key highlights from the clinical data presentation include:
- An overall response rate (ORR) of 24% (ITT) n = 50 was
observed.
- An ORR of 22.2% in the 2 mg cohort and an ORR of 26.1% in the 8
mg cohort were observed.
- An ORR of 33.3% and a disease control rate (DCR) of 41.6% were
observed in patients with low PD-L1 status at baseline.
- An ORR of 36% was observed in patients with HPV-positive
tumors.
- Biomarker data are consistent with the mechanism of action of
SD-101 and demonstrate strong immunomodulation of the tumor
microenvironment including infiltration of activated T cells and
upregulation of Type I and Type II Interferon (IFN).
- Importantly, similar to what was reported for melanoma patients
who had not received anti-PD-1 therapy (ASCO 2019 Abstract 9534),
patients whose tumors exhibited an immunologically cold tumor
microenvironment at baseline (low IFNγ and T cell signatures)
showed clinical response during SD-101 plus pembrolizumab
treatment.
- The combination of SD-101 and pembrolizumab was well-tolerated,
consistent with previous reports.
- No evidence of an increased incidence or severity of adverse
events (AEs) over pembrolizumab monotherapy.
- No increase in immune-related AEs over pembrolizumab
monotherapy.
- AEs associated with SD-101 were mainly mild to moderate
injection-site reactions and flu-like symptoms that were manageable
with over-the-counter medication.
About SD-101SD-101 is a proprietary,
second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class
oligodeoxynucleotide. Dynavax is evaluating SD-101 in several
clinical studies to assess its safety and activity, including a
Phase 2 study in combination with KEYTRUDA® (pembrolizumab) in
advanced melanoma and metastatic or recurrent head and neck
squamous cell cancer in collaboration with Merck, and in high risk
breast cancer in collaboration with I-SPY 2. 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 is currently
exploring strategic alternatives for its immuno-oncology portfolio.
The Company launched its first commercial product, HEPLISAV-B®
[Hepatitis B Vaccine (Recombinant), Adjuvanted], in February 2018,
following U.S. FDA approval for prevention of infection caused by
all known subtypes of hepatitis B virus in adults age 18 years and
older. For more information, visit www.dynavax.com.
Forward-Looking Statements This press release
contains "forward-looking" statements, including statements
regarding the conduct of clinical trials of SD-101, including
results from the Phase 2 cohort expansion of 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 by us or another party; issues arising in the
regulatory process; the ability to successfully develop or pursue
strategic alternatives for SD-101, including the funding of future
studies, as well as other risks detailed in the "Risk Factors"
section of our Annual Report on Form 10-K for the fiscal year ended
December 31, 2018 and in our Quarterly Report on Form 10-Q for the
quarter ended March 31, 2019, as well as discussions of potential
risks, uncertainties and other important factors in our other
filings with the U.S. Securities and Exchange Commission (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.
Contact:
Heather Rowe
Vice President, Investor Relations & Corporate Communications
hrowe@dynavax.com
510-665-7269
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