Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) (the Company) today is
announcing final topline data from the ILLUMINATE-204 trial
investigating intratumoral tilsotolimod, Idera’s investigational
Toll-like receptor 9 (TLR9) agonist.
ILLUMINATE-204 is a multi-center, two-arm phase 1/2 trial in
patients with anti-PD-1 refractory advanced melanoma. The phase 1
portion of the trial tested the safety and efficacy of increasing
doses of tilsotolimod in combination with either Yervoy®*
(ipilimumab) or Keytruda®± (pembrolizumab). The phase 2
expansion of the trial enrolled additional patients at the
recommended phase 2 dose (RP2D) of 8 mg of tilsotolimod in
combination with Yervoy®, which is the treatment regimen being
evaluated for the same indication in the Company’s registrational
trial, ILLUMINATE-301.
“The clinical benefit suggested for these anti-PD-1 refractory
melanoma patients with limited treatment options includes
stabilization of disease and even responses, which is creating hope
that this combination might be of benefit to patients in the PD-1
refractory setting,” stated Joseph Markowitz, M.D., Ph.D., from the
H. Lee Moffitt Cancer Center & Research Center in Tampa,
Florida. “We eagerly await the outcome of the ongoing phase 3 trial
to see whether this combination treatment with ipilimumab will
represent an additional option for patients with advanced
melanoma.”
ILLUMINATE-204 Key Findings: The study
included 52 patients treated with 8 mg of tilsotolimod in
combination with Yervoy®.
- 49 patients were evaluable for efficacy.
- Median overall survival (OS) was 21.0 months (95% confidence
interval (CI): 9.8 months-not reached (NR)).
- The overall response rate (ORR) per Response Evaluation
Criteria in Solid Tumors (RECIST v1.1) was 22.4%, including 2
complete responses (95% CI: 11.8-36.6%).- The disease control
rate (stable disease or better) was 71.4% (95% CI:
56.7%-83.4%).- Median duration of response was 11.4 months
(95% CI: 3.3 months-NR).- 7 of 11 RECIST v1.1 responses were
durable for greater than 6 months.- Tumor reduction was
observed in both injected and noninjected tumors.
- The combination regimen was generally well tolerated among the
62 patients receiving tilsotolimod at any dose in combination with
Yervoy®.- 48% of patients reported a maximum Grade 3 or 4
treatment emergent adverse event (TEAE).- The most common
serious TEAEs were autoimmune hepatitis, hyponatremia, and
hypophysitis (n=2 for each).- 26% of patients reported
immune-related toxicities, suggesting that tilsotolimod + Yervoy®
does not add immune-related toxicity versus Yervoy® alone.-
There were no TEAEs leading to discontinuation or death.
Final data from ILLUMINATE-204 is planned for submission to a
medical meeting in the second half of 2020.
“The outcomes from this study encourage our belief that the
combination of tilsotolimod and ipilimumab may provide a
much-needed treatment option for advanced melanoma patients who
have limited available therapies,” stated Elizabeth Tarka, M.D.,
Idera’s Chief Medical Officer. “We are looking forward to
completing our registrational trial for this indication,
ILLUMINATE-301, where a comparator arm is included, and moving this
potential therapy one step closer to patients in need.”
Continued Dr. Tarka, “As with many of our peers, we are intently
monitoring the COVID-19 pandemic and its potential effect on the
ILLUMINATE-301 trial. We are working closely with our investigators
and partners and taking proactive steps to help protect the safety
of our study participants and clinical trial staff while also
ensuring the scientific integrity of the trial data. Based on what
we know today, and while recognizing the environment could rapidly
change, we currently expect to achieve our target of sharing key
topline data from the trial in the first quarter of 2021.”
About ILLUMINATE-204ILLUMINATE-204 is a
multi-center, two-arm Phase 1/2 trial that tested the safety and
effectiveness of tilsotolimod in combination with either Yervoy®
(ipilimumab) or Keytruda® (pembrolizumab) in patients with
anti-PD-1 refractory metastatic melanoma. For more information on
ILLUMINATE-204, please refer to ClinicalTrials.gov
(NCT02644967).
About ILLUMINATE-301ILLUMINATE-301 is a
randomized, phase 3 trial comparing the effectiveness of
intratumoral tilsotolimod in combination with ipilimumab with
ipilimumab alone in approximately 450 patients with anti-PD-1
refractory advanced melanoma, with a primary endpoint family of ORR
per RECIST v1.1 and OS. Key secondary endpoints include durable
response rate, time to response, progression-free survival,
patient-reported outcomes, and safety. For more information on
ILLUMINATE-301, please refer to ClinicalTrials.gov
(NCT03445533).
About Anti-PD-1 Refractory Advanced
MelanomaMelanoma is a cancer that begins in a type of skin
cell called melanocytes. While melanoma is the least common type of
skin cancer, it has a poor prognosis when not detected and treated
early. As is the case in many forms of cancer, melanoma becomes
more difficult to treat once the disease has spread, or
metastasized, beyond the skin to other parts of the body. According
to the American Cancer Society, approximately 100,000 people in the
US will be diagnosed with invasive melanoma this year. In recent
years, pioneering immunotherapies known as checkpoint inhibitors
(CPIs) have changed the treatment of advanced melanoma and have
become the standard of care, with anti-PD-1 agents being the most
commonly used immunotherapy in the first-line setting. These agents
work by increasing the ability of the body’s immune system to help
detect and fight cancer cells. However, due to primary or acquired
resistance mechanisms that exclude or inhibit anti-tumor immune
cells, as many as 60% of patients do not benefit from this type of
therapy, and up to one-third of initial responders develop
resistance to the therapy and ultimately experience disease
progression. Today, these refractory patients are left with few
options for further treatment, paving the way for novel
investigational therapies such as tilsotolimod.
About Tilsotolimod (IMO-2125)Tilsotolimod is an
investigational, synthetic Toll-like receptor 9 agonist.
Intratumoral injection of tilsotolimod has been shown to promote
both innate and adaptive immune activation. Tumors with an active
immune response appear to respond better to CPIs than those that
exclude or inhibit anti-tumor immune cells. Tilsotolimod in
combination with CPIs may cause regression of locally injected and
distant tumor lesions and increase the number of patients who
benefit from immunotherapy.
Tilsotolimod has received both Fast Track designation and Orphan
Drug designation from the FDA and is being evaluated in multiple
tumor types and in combination with multiple checkpoint inhibitors.
For more information on tilsotolimod trials, please visit
ClinicalTrials.gov.
About Idera PharmaceuticalsHarnessing the
approach of the earliest researchers in immunotherapy and the
company’s vast experience in developing proprietary immunology
platforms, Idera’s development program is focused on priming the
immune system to play a more powerful role in fighting cancer,
ultimately increasing the number of people who can benefit from
immunotherapy. Idera also continues to focus on the acquisition,
development, and ultimate commercialization of drug candidates for
both oncology and rare disease indications characterized by small,
well-defined patient populations with serious unmet needs. To learn
more about Idera, visit IderaPharma.com.
Forward-Looking Statements This press release
contains forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, as amended, and Section 21E of
the Securities Exchange Act of 1934, as amended. All statements,
other than statements of historical fact, included or incorporated
in this press release, including statements regarding the Company's
strategy, future operations, collaborations, intellectual property,
cash resources, financial position, future revenues, projected
costs, prospects, clinical trials, plans, and objectives of
management, are forward-looking statements. The words "believes,"
"expects," "anticipates," "estimates," "plans," "expects,"
"intends," "may," "could," "should," "potential," "likely,"
"projects," "continue," "will," and "would" and similar expressions
are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words.
Idera cannot guarantee that it will actually achieve the plans,
intentions or expectations disclosed in its forward-looking
statements and you should not place undue reliance on the Company's
forward-looking statements. There are a number of important factors
that could cause Idera's actual results to differ materially from
those indicated or implied by its forward-looking statements.
Factors that may cause such a difference include: whether the
Company’s cash resources will be sufficient to fund the Company’s
continuing operations and the further development of the Company’s
programs for the period anticipated; whether interim results from a
clinical trial, such as the preliminary results reported in this
release, will be predictive of the final results of the trial;
whether results obtained in preclinical studies and clinical trials
such as the results described in this release will be indicative of
the results that will be generated in future clinical trials,
including in clinical trials in different disease indications;
whether products based on Idera's technology will advance into or
through the clinical trial process when anticipated or at all or
warrant submission for regulatory approval; whether such products
will receive approval from the U.S. Food and Drug Administration or
equivalent foreign regulatory agencies; whether, if the Company's
products receive approval, they will be successfully distributed
and marketed; whether the Company's collaborations will be
successful; and such other important factors as are set forth under
the caption "Risk factors" in the Company’s Annual Report filed on
Form 10-K for the period ended December 31, 2019. Although Idera
may elect to do so at some point in the future, the Company does
not assume any obligation to update any forward-looking statements
and it disclaims any intention or obligation to update or revise
any forward-looking statement, whether as a result of new
information, future events or otherwise.
*Yervoy (ipilimumab) is a registered trademark of Bristol Myers
Squibb.
±Keytruda (pembrolizumab) is a registered trademark of Merck
Sharp & Dohme, a subsidiary Merck & Co., Inc.
IDERA PHARMACEUTICALS Contacts:
Jill Conwell
Investor Relations &
Corporate Communications
Phone (484) 348-1675
JCONWELL@IDERAPHARMA.COM
John J. Kirby
Chief Financial Officer
Phone (484) 348-1627
JKIRBY@IDERAPHARMA.COM
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