Dynavax’s SD-101 in Combination with KEYTRUDA® (pembrolizumab) Continues to Show a 70% Overall Response Rate in Advanced M...
October 20 2018 - 8:45AM
- 70% overall response rate (33/47 patients) at 2
mg dose of SD-101 includes 17 additional patients -
Dynavax Technologies Corporation (NASDAQ:DVAX) today presented
interim data from its ongoing Phase 1b/2 SYNERGY-001 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 naïve to anti-PD-1/L1
therapy. These data were presented in a late breaking poster and
discussion session today at the ESMO 2018 Congress, in Munich,
Germany.
The company reported results on a total of 87 patients
(Intention to Treat population) comparing two different doses of
SD-101. In the study, 47 patients received ≤2mg of SD-101 in 1-4
lesions and 40 patients received 8 mg in a single lesion. The
primary endpoints of this dose-expansion/dose-finding study are
safety and preliminary efficacy. The results showed a 70% overall
response rate (ORR) in advanced melanoma patients naïve to
anti-PD-1/L1 therapy who received the ≤ 2 mg dose of SD-101 and a
48% ORR in the group receiving the 8 mg dose of SD-101. The
combination of SD-101 and KEYTRUDA remains well tolerated with
adverse events related to SD-101 being transient, mild to moderate
flu-like symptoms.
“These results are encouraging because the overall response rate
in the 2 mg group has remained consistent with the data presented
at the 2018 American Society for Clinical Oncology annual meeting,
even though the number of patients increased by more than 50
percent. In addition, median progression-free survival has not yet
been reached, but statistically is expected to be at least 15.2
months, providing further validation of the potential benefit of
the combination therapy,” said Rob Janssen, M.D., Chief Medical
Officer. “These data underscore the value of stimulating the innate
immune response through TLR9 and build on clinical evidence around
the proposed mechanism of action for SD-101.”
Highlights from the poster presentation (LBA45)
- ORR of 70% (33 of 47), for advanced melanoma patients who
received the ≤ 2 mg dose of SD-101 per lesion
- Durable response in patients who received ≤ 2 mg dose of SD-101
with 85% 6-month progression-free survival (PFS) rate
- Median PFS not reached in patients who received ≤ 2 mg dose of
SD-101 with a lower bound of the 95% confidence interval suggesting
a minimum ongoing PFS of 15.2 months
- Observed responses in injected lesion(s) and non-injected
distant lesions, including visceral metastases in the liver and
lung
- Response rates appeared similar regardless of PD-L-1
status
- 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
Dynavax Conference Call and WebcastDynavax will
host a conference call and webcast on Sunday at 1:00pm EDT (7:00 PM
CEST). The live webcast can be accessed in the "Investors and
Media" section of the company's website at www.dynavax.com. The
conference call can be accessed by dialing (866) 420-4066 in the
U.S. or (409) 217-8237 internationally, using the conference ID
2036717. A replay of the webcast will be available following the
live event.
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-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 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 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], was approved by the United States Food and Drug
Administration in November 2017 for prevention of infection caused
by all known subtypes of hepatitis B virus in adults age 18 years
and older. 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, including
results from 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; 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 Annual Report
on Form 10-K for the fiscal year ended December 31, 2017 and in
Quarterly Report on Form 10-Q for the quarter ended June 30, 2018,
as well as discussions of potential risks, uncertainties and other
important factors in our other filings with the U.S. Securities and
Exchange Commission. 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.1. Ribas A, et al.
JAMA. 2016;315(15):1600-1609.2. Specenier P. Expert Opin Biol Ther.
2017;17(6):765-780.
Contact: |
Media Contact: |
|
Ryan Spencer |
Rachel St. Martin |
|
VP Corporate Strategy and Communications |
W2O |
|
510.665.4608 |
646.894.5757 |
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|
rstmartin@w2ogroup.com |
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