Data Highlighting Advaxis’ ADXS-PSA Presented at ASCO Annual Meeting
June 01 2018 - 8:00AM
Business Wire
Advaxis, Inc. (NASDAQ:ADXS), a late-stage
biotechnology company focused on the discovery, development and
commercialization of immunotherapy products, today announced
preliminary data from the ongoing metastatic, castration resistant
prostate cancer (mCRPC) Phase 1/2 KEYNOTE-046 study, conducted in
conjunction with Merck (known as MSD outside the United States and
Canada) evaluating ADXS-PSA, Advaxis’s Listeria monocytogenes
(Lm)-based immunotherapy, alone and in combination with KEYTRUDA®
(pembrolizumab), Merck’s anti-PD-1 therapy.
Findings will be highlighted in a poster discussion at the 2018
American Society of Clinical Oncology (ASCO) Annual Meeting
underway in Chicago, on Saturday, June 2, from 4:45 pm to 6:00 p.m.
CDT (Location: Hall A; Poster #246; Abstract #5019). Principal
Investigator and author Naomi Haas, MD, Director of the Prostate
and Kidney Cancer Programs and Associate Professor of Medicine at
the Hospital of the University of Pennsylvania will be
presenting.
ADXS-PSA was tested alone or in combination with KEYTRUDA in an
advanced and heavily pretreated patient population who had
progressed on androgen deprivation therapy. A total of 13 and 37
patients were evaluated on monotherapy and combination therapy,
respectively. Overall, the safety profile was consistent with
findings from prior clinical studies using the Lm platform.
Treatment-related adverse events (TRAEs) were mostly mild or
moderate constitutional symptoms such as fever, chills, rigors,
hypotension, nausea and fatigue, consistent with immune activation
and manageable with standard care. One patient in the monotherapy
arm was discontinued from the study due to a grade 4 TRAE related
to cytokine release, which resolved within 24 hours using medical
management. There were no new toxicities observed with the
combination therapy. In all treated patients, those who received
the combination therapy experienced the longest overall survival
(OS) at data cut-off, with the median not having been reached at 13
months of follow-up.
“Improvements in the care and treatment of highly refractory
prostate cancer, a traditionally difficult type of cancer to treat,
are vital. These early results show a safe and tolerable profile
for ADXS-PSA alone or in combination with KEYTRUDA,” said Dr. Haas.
“Albeit the study was not designed to compare monotherapy to
combination therapy, the survival rates in the combination therapy
arm are encouraging, especially given the reduction in PSA levels
observed in this group, and mature data in the following 6 months
will help better define the role of ADXS-PSA in combination with
KEYTRUDA in mCRPC.”
Key Findings from KEYNOTE-046 (as of March 30, 2018):
- The advanced patient population in the
study had a median Gleason score of 8.3, and was heavily
pretreated, with greater than 70% having received three or more
prior lines of therapy.
- Median overall survival had not been
reached in the combination arm after 13 months of follow-up (95%CI
7.16-NR), and was 7.79 months (95%CI 3.52-11.9) in the monotherapy
arm.
- 56.8% of patients on combination
therapy and 38.5% of patients on monotherapy did not experience
disease progression.
- The percentage of patients with PSA
declines from baseline in the combination therapy arm was 40.5%,
and 15.4% in the monotherapy arm.
- In all treated patients, an improvement
in survival was observed in patients with PSA declines from
baseline of 50% or greater vs. those with PSA declines of less than
50%. There were 7 patients in the combination arm with 50% or
greater declines in PSA from baseline, and none in the monotherapy
arm.
Previously presented immunologic data from the monotherapy arm
of this trial showed that ADXS-PSA induced or enhanced T cell
responses not only to PSA, but also to other prostate cancer
antigens that were not expressed by the Lm-based vector, which is
indicative of antigen cascade or antigen spreading (SITC 2017;
Hayes et al. J Immunother Cancer. 2017;5(Suppl 2)86:P2).
Correlative immunologic analyses and overall survival for the
combination therapy patients are underway.
About KEYNOTE-046
KEYNOTE-046 (NCT02325557) is a Phase 1/2 open-label, multicenter
dose determination and expansion trial that evaluates the safety,
tolerability and preliminary clinical activity of ADXS-PSA as
monotherapy (Part A; n=14 [13 treated]), and in combination with
KEYTRUDA (Part B; n= 37) in heavily pretreated patients with
progressive and refractory mCRPC. Patient accrual in the study is
complete, with 5 patients still receiving treatment, all in Part B,
and being followed for survival analysis.
About ADXS-PSA
ADXS-PSA, one of Advaxis's Listeria monocytogenes (Lm) based
immunotherapies, utilizes live, attenuated, bioengineered Lm as a
vector to deliver PSA directly to antigen presenting
cells. Development is being pursued in a clinical trial
collaboration and supply agreement with Merck.
About Advaxis, Inc.
Advaxis, Inc. is a late-stage biotechnology company focused on
the discovery, development and commercialization of proprietary
Lm-based antigen delivery products. These immunotherapies are based
on a platform technology that utilizes live attenuated Listeria
monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion
proteins. These Lm-based strains are believed to be a significant
advancement in immunotherapy as they integrate multiple functions
into a single immunotherapy and are designed to access and direct
antigen presenting cells to stimulate anti-tumor T cell immunity,
activate the immune system with the equivalent of multiple
adjuvants, and simultaneously reduce tumor protection in the tumor
microenvironment to enable the T cells to eliminate tumors. Advaxis
has four franchises in various stages of clinical and preclinical
development: HPV-associated cancers, neoantigen therapy, hotspot/
cancer antigens and prostate cancer.
To learn more about Advaxis, visit www.advaxis.com and connect
on Twitter, LinkedIn, Facebook, and YouTube.
Advaxis Forward-Looking Statement
This press release contains forward-looking statements,
including, but not limited to, statements regarding Advaxis’
ability to develop and commercialize the next generation of cancer
immunotherapies, and the safety and efficacy of Advaxis’
proprietary immunotherapies. These forward-looking statements are
subject to a number of risks including the risk factors set forth
from time to time in Advaxis’ SEC filings including, but not
limited to, its report on Form 10-K for the fiscal year ended
October 31, 2017, and on Form 10-Q for the quarter ended January
31, 2018, which are available at www.sec.gov.
Any forward-looking statements set forth in this presentation
speak only as of the date of this presentation. We do not intend to
update any of these forward-looking statements to reflect events or
circumstances that occur after the date hereof other than as
required by law. You are cautioned not to place undue reliance on
any forward-looking statements.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J.,
USA.
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version on businesswire.com: https://www.businesswire.com/news/home/20180601005075/en/
Company:Advaxis, Inc.Noelle Heber, 609-250-7575Sr.
Director Corporate Communications and Government
AffairsHeber@advaxis.comorInvestors:LHA Investor
RelationsMiriam Weber Miller, 212-838-3777mmiller@lhai.com
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