Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company
focused on oncology, today announced that an interim analysis of
its ongoing, randomized Phase 2 trial showed that NY-ESO-1+
soft tissue sarcoma (STS) patients receiving the combination of
CMB305 and Genentech’s checkpoint inhibitor, atezolizumab
(TECENTRIQ
®), experienced greater clinical benefit
and immune response than those receiving atezolizumab alone. The
data will be presented in a poster discussion session at the
European Society of Medical Oncology (ESMO) 2017 Congress,
September 8-12, 2017 in Madrid, Spain.
This fully enrolled trial is evaluating the safety,
immunogenicity and efficacy of CMB305 in combination with
atezolizumab (C+A, n=45), or atezolizumab alone (A, n=43), in a
total of 88 patients with locally advanced, relapsed, or metastatic
NY-ESO-1+ synovial sarcoma or myxoid/round-cell liposarcoma. Data
to be presented at ESMO summarize patients evaluated in an interim
analysis in a data cut as of July 21, 2017, with analysis divided
into two groups: pre-specified interim analysis (n=36) and full
study population (n=88).
Patient Characteristics:
Patients receiving CMB305 plus atezolizumab have
more advanced disease than those receiving atezolizumab alone,
including:
- Metastatic Disease: 98% (C+A) vs. 79% (A)
- ≥2 prior lines of systemic anti-cancer therapy: 61% (C+A) vs.
49% (A)
- ≥2 lesions at time of study entry: 96% (C+A) vs. 84%
(A)
- Grade 3 disease at diagnosis: 47% (C+A) vs. 33% (A)
Greater Clinical Benefit with Combination
of CMB305 and Atezolizumab:
Interim analysis data (n=36) show that patients
receiving CMB305 plus atezolizumab experienced greater clinical
benefit than those receiving atezolizumab alone.
- Disease Control Rate (Partial Responses (PR) + Stable Disease
(SD)): 61%, including 1 PR (C+A) vs. 28% with no PRs (A)
- Median Progression Free Survival (PFS): 2.6 months (C+A) vs.
1.4 months (A)
- Time to Next Treatment (TTNT): 9 months (C+A) vs. 6.3 months
(A)
- Overall survival: as of the collection date, overall survival
data are immature (median duration of observation is less than six
months); Immune Design intends to present survival data in 2018
once all patients approach at least one year of follow up.
In the full study population (n=88), the trend of
greater clinical benefit on the combination arm remains consistent
for the entire patient population:
- Disease Control Rate: 57% (3 PRs total, 1 unconfirmed) (C+A)
vs. 38% (0 responses) (A)
More Robust Immune Response with
Combination of CMB305 and Atezolizumab:
Patients in the full study population (n=88) who
received the combination of CMB305 and atezolizumab demonstrated
stronger anti-NY-ESO-1 immune responses compared to those receiving
atezolizumab alone (samples evaluable from (n=60/88)),
including:
- Induced anti-NY-ESO-1 T cells: 52% (C+A) vs. 17% (A)
- Induced anti-NY-ESO-1 antibodies: 52% (C+A) vs. 0% (A)
- Induced antigen spreading: 19% (C+A) vs. 0% (A)
Biomarker Analysis Shows Continued Link
Between Induced Immune Response and Clinical Benefit:
In an exploratory analysis, a trend towards
improved overall survival was observed in patients with an induced
immune response (T cells or antibodies) who received CMB305 plus
atezolizumab.
- Induced anti-NY-ESO-1 T cells: 78% reduction in mortality rate,
as compared to patients without induced T cells [HR=0.22, log-rank
p value=0.043]
- Induced anti-NY-ESO-1 antibodies: 87% reduction in mortality
rate, as compared to patients without induced antibodies [HR=0.13,
log-rank p value=0.025]
- This trend of improved overall survival in patients with
induced immune response was not observed in the atezolizumab-only
arm.
In addition, pretreatment tumor biopsies available
from 70 patients show both an absent or very low level of PD-L1
expression and CD8 T cell infiltration, further supporting that
these subtypes of STS are "cold" tumors.
Positive Safety Profile with Combination of
CMB305 and Atezolizumab:
This combination was observed to be well tolerated,
and there were no new safety signals in either arm.
“We believe the greater clinical benefit and more
robust immune response shown in the combination study arm supports
the hypothesis that the combination of an appropriately-designed,
next-generation cancer vaccine such as CMB305 with a checkpoint
inhibitor is important to produce clinical benefit in a cold tumor
such as STS, where checkpoint inhibitors otherwise may have limited
efficacy,” said Carlos Paya, M.D., Ph.D., President and Chief
Executive Officer of Immune Design. “In addition, we are pleased to
observe the trend towards longer overall survival in patients with
an induced anti-NY-ESO-1 immune response, further supporting the
positive CMB305 monotherapy data we presented at ASCO in June.”
Atezolizumab is a monoclonal antibody being
developed by Genentech, a member of the Roche Group, and is
designed to target and bind to a protein called PD-L1 (programmed
death ligand-1). The trial is being conducted pursuant to a
clinical collaboration with Genentech. TECENTRIQ® is a
registered trademark of Genentech.
The ESMO Poster Discussion session presentation
details are as follows:
A Phase 2 Study of CMB305 and Atezolizumab
in NY-ESO-1+ Soft Tissue Sarcoma: Interim Analysis of
Immunogenicity, Tumor Control and Survival
Abstract # 1480PDSession Title: Sarcoma Poster
Discussion SessionDate: Monday, Sept. 11, 2017Time: 11 a.m. – 12:30
p.m. Location: Bilbao AuditoriumPoster Presenter: Dr. Sant
ChawlaPoster Discussant: Dr. Robert Maki
About CMB305
CMB305 is a prime-boost vaccine approach
against NY-ESO-1-expressing tumors, designed to generate an
integrated, anti-NY-ESO-1 immune response in vivo via a
targeted, specific interaction with dendritic cells, a mechanism of
action Immune Design believes differs from traditional cancer
vaccines. CMB305 is being evaluated in soft tissue sarcoma patients
in ongoing Phase 1 monotherapy and Phase 2 combination studies.
Immune Design has received Orphan Drug Designation for CMB305 from
the U.S. Food and Drug Administration (FDA) for the treatment of
soft tissue sarcoma, as well as from the FDA and European Medicines
Agency for each of the components of CMB305 for the treatment of
soft tissue sarcoma.
About Immune Design
Immune Design is a clinical-stage immunotherapy
company employing next-generation in vivo approaches to
enable the body's immune system to fight disease. The company's
technologies are engineered to activate the immune system's natural
ability to generate and/or expand antigen-specific cytotoxic T
cells, while also enhancing other immune effectors, to fight cancer
and other chronic diseases. CMB305 and G100, the two leading
product candidates focused in cancer immunotherapy, are the first
products from Immune Design’s two separate discovery platforms
targeting dendritic cells in vivo, ZVex® and GLAAS®. Both
ZVex and GLAAS also have potential applications in infectious
disease and allergy as demonstrated by ongoing pharmaceutical
collaborations. Immune Design has offices in Seattle and
South San Francisco. For more information, please
visit www.immunedesign.com.
Cautionary Note on Forward-Looking
Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Words such as "may," "will," "expect," "plan,"
"anticipate," "estimate," "intend" and similar expressions (as well
as other words or expressions referencing future events, conditions
or circumstances) are intended to identify forward-looking
statements. These forward-looking statements are based
on Immune Design's expectations and assumptions as of the
date of this press release. Each of these forward-looking
statements involves risks and uncertainties that could cause our
clinical development programs, future results or performance to
differ significantly from those expressed or implied by the
forward-looking statements. Forward-looking statements contained in
this press release include, but are not limited to, statements
about the progress, timing, scope and results of clinical trials,
the association of data with treatment outcomes, and the timing and
likelihood of obtaining regulatory approval of Immune Design's
product candidates. Many factors may cause differences between
current expectations and actual results including unexpected safety
or efficacy data observed during preclinical or clinical studies,
clinical trial site activation or enrollment rates that are lower
than expected, changes in expected or existing competition, changes
in the regulatory environment, the uncertainties and timing of the
regulatory approval process, and unexpected litigation or other
disputes. Other factors that may cause Immune
Design's actual results to differ from those expressed or
implied in the forward-looking statements in this press release are
discussed in Immune Design's filings with the U.S.
Securities and Exchange Commission, including the "Risk Factors"
sections contained therein. Except as required by law, Immune
Design assumes no obligation to update any forward-looking
statements contained herein to reflect any change in expectations,
even as new information becomes available.
Media Contact
Julie Rathbun
Rathbun Communications
julie@rathbuncomm.com
206-769-9219
Investor Contact
Shari Annes
Annes Associates
sannes@annesassociates.com
650-888-0902
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