- Achieved primary objective of 12-month survival
rate, demonstrating axalimogene filolisbac is an active therapy in
metastatic cervical cancer
Advaxis, Inc. (NASDAQ:ADXS), a biotechnology company developing
cancer immunotherapies, presented data from the GOG-0265 study at
the Society of Gynecologic Oncology’s Annual Meeting on Women’s
Cancer in National Harbor, MD. GOG-0265 is a single arm,
Phase 2 trial evaluating axalimogene filolisbac for the treatment
of persistent or recurrent metastatic (squamous or non-squamous
cell) carcinoma of the cervix (PRmCC). The primary endpoints
of the study were to assess the safety and efficacy of axalimogene
filolisbac in women with PRmCC. The primary efficacy endpoint
was overall survival at 12 months from initial treatment with
axalimogene filolisbac. The primary safety endpoints were to
evaluate the number of patients with dose-limiting toxicities and
the frequency and severity of adverse effects.
The final efficacy results of GOG-0265
demonstrated that 38% of patients (n = 19/50) with heavily
pretreated PRmCC were alive 12 months following treatment with
axalimogene filolisbac. The GOG-0265 study protocol used a
logistic model-based calculation to establish the expected 12-month
survival rate. The model identified the key prognostic
factors of age, race and performance status significantly related
to survival from a database of approximately 500 patients with
PRmCC who participated in 17 previous phase 2 studies conducted by
the Gynecologic Oncology Group (GOG), now part of NRG Oncology.
Using this model, the expected 12-month survival rate of
patients enrolled in the study was calculated to be 24.5%. As
a result, the 38% 12-month survival rate of patients treated with
axalimogene filolisbac represents a 52% improvement over the
expected survival rate and is the highest 12-month survival rate
achieved to date in this setting. The probability of this
survival improvement being detected by chance versus a true
treatment effect was calculated to be 0.02. A compelling and
ongoing complete response of 18.5 months was observed and the
longest ongoing survival is 40.6 months.
“The 12-month survival rate of axalimogene
filolisbac reached unprecedented levels in this study, which is
both impressive and important given the lack of innovation in
metastatic cervical cancer,” said Warner K. Huh, MD, Division
Director of Gynecologic Oncology at the University of Alabama at
Birmingham, and Lead Investigator of the study.
The safety profile was consistent with previous
clinical experience. The most common Grade 1 or Grade 2
treatment-related adverse events (TRAEs) were hypotension and
symptoms related to cytokine release (e.g., nausea, chills, fever).
Eighteen out of 50 patients experienced a Grade 3 TRAE and
two out of 50 patients experienced a Grade 4 TRAE, which were
hypotension and symptoms related to cytokine release.
The abstract was selected by SGO for prominence
as an oral late-breaking presentation by Charles A. Leath III,
M.D., MSPH, Associate Professor of Obstetrics and Gynecology at the
University of Alabama at Birmingham School of Medicine, entitled,
“A prospective phase 2 trial of the listeria-based HPV
immunotherapy axalimogene filolisbac in second and third-line
metastatic cervical cancer: A NRG Oncology Group trial,” on March
14 at 2:30 p.m. ET. Slides from the presentation are available at
www.advaxis.com/sgo2017. Highlights from Dr. Leath’s presentation
include:
- A 38% (n = 19/50) 12-month survival rate in second- and
third-line PRmCC treated with axalimogene filolisbac, representing
a 52% improvement over the expected 12-month milestone survival
rate of 24.5%
- Eight patients remain alive as of January 31, 2017 (Range 12.02
– 40.6 months)
- Disease control (complete response, partial response, or stable
disease) was achieved in 32% of patients based on investigator
assessment of best response
- A durable complete response in a patient with PRmCC previously
treated with chemotherapy and bevacizumab remains ongoing at 18.5
months
- Results compare favorably to GOG Study 227C of bevacizumab,
which demonstrated a 12-month milestone overall survival (OS) rate
of 30% in a similar patient population which subsequently supported
regulatory approval in first-line treatment in combination with
chemotherapy in 2014
- Consistent with its immunotherapy mechanism of action,
axalimogene filolisbac demonstrated a promising plateau in the
survival curve, indicating potential long-term clinical benefit for
a subset of patients with PRmCC
- Axalimogene filolisbac was generally well-tolerated, with
primarily infusion-associated, low grade, transient TRAEs (≥30%),
such as fatigue, chills, anemia, nausea and fever
- Only 2 patients experienced grade 4 TRAEs
Advaxis plans to initiate a global, phase 3
randomized registration study in patients with metastatic cervical
cancer later this year.
About the Phase 2 GOG-0265 Study
GOG-0265 is an open-label, single arm 2-stage
study designed to evaluate the safety, tolerability and efficacy of
axalimogene filolisbac to treat PRmCC as conducted by the
Gynecologic Oncology Group (GOG), now part of NRG Oncology.
Patients who progressed on or after at least 1 prior line of
systemic-dose chemotherapy receive one cycle (three doses) of
axalimogene filolisbac at 1 x 109 CFU every 28 days. The
primary efficacy endpoint was the 12-month survival rate, with
secondary efficacy objective to evaluate progression-free survival,
overall survival and objective tumor response. The primary
safety endpoints were to evaluate the number of patients with
dose-limiting toxicities and the frequency and severity of adverse
effects.
The expected 12-month overall survival rate
(null hypothesis) was established using a prospectively-defined
logistic model-based calculation derived from 17 serially conducted
GOG/NRG 2-stage studies in PRmCC involving approximately 500
patients, adjusting for prognostic factors (age, performance
status, race) significantly related to survival. In
accordance with the prior trials, GOG/NRG used a consistent
protocol design/data collection methodology for the current 2-stage
GOG-0265 study in PRmCC, which contributed to a robust and
homogeneous patient dataset for the primary endpoint analysis.
About Cervical Cancer
Cervical cancer is the fourth most common cancer
in women worldwide. An estimated 13,000 new cases will be
diagnosed in the United States in 2016, and 4,100 people will die
of the disease, according to the National Cancer Institute.
Persistent HPV infection is the most important factor in the
development of cervical cancer, research shows. According to
the ICO Information Centre on HPV and Cervical Cancer, about 4.4%
of women in the United States are estimated to harbor high-risk
cervical HPV infection at a given time, and about 72% of cervical
cancers are attributed to high-risk HPV strains. PRmCC is a
fatal disease, and the prognosis for women with advanced and
recurrent cervical cancer remains poor, with survival of only 4 to
7 months following failure of first-line treatment, research has
shown. There is no therapy following failure of first-line
treatment. According to the American Cancer Society, the
five-year mortality rate for metastatic disease is at just 17%,
with the area continuing to be a high unmet medical need.
About the GOG Foundation,
Inc.
The GOG Foundation, Inc. (GOG) is a non-profit
international organization with the purpose of promoting excellence
in the quality and integrity of clinical and basic scientific
research in the field of gynecologic malignancies. The GOG is
committed to maintaining the highest standards in clinical trials
development, execution, analysis and distribution of results.
Continuous evaluation of its processes is utilized in order
to constantly improve the quality of patient care. The GOG
conducts clinical trials for patients with a variety of gynecologic
malignancies, including cancers that arise from the ovaries,
uterus, cervix, vagina and vulva. General information on many
of these trials for medical professionals and the lay public can be
obtained from ClinicalTrials.gov.
NRG Oncology is one of four adult US Network
groups funded under the newly structured NCI National Clinical
Trials Network. NRG Oncology is comprised of three legacy
cooperative groups, the National Surgical Adjuvant Breast and Bowel
Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and
the Gynecologic Oncology Group (GOG).
About Advaxis, Inc.
Located in Princeton, N.J., Advaxis, Inc. is a
biotechnology company developing multiple cancer immunotherapies
based on its proprietary Lm Technology™.
The Lm Technology, using bioengineered live
attenuated Listeria monocytogenes (Lm) bacteria, is the
only known cancer immunotherapy agent shown in preclinical studies
to both generate cancer fighting T cells directed against cancer
antigens and neutralize Tregs and myeloid-derived suppressor cells
(MDSCs) that protect the tumor microenvironment from immunologic
attack and contribute to tumor growth. Advaxis'
lead Lm Technology immunotherapy, axalimogene filolisbac,
targets HPV-associated cancers and is in clinical trials for three
potential indications: Phase 3 in invasive cervical cancer, Phase 2
in head and neck cancer, and Phase 2 in anal cancer. The FDA
has granted axalimogene filolisbac orphan drug designation for each
of these three clinical settings, as well as Fast Track designation
for adjuvant therapy for high risk locally advanced cervical cancer
(HRLACC) patients and a SPA for the Phase 3 AIM2CERV trial in
HRLACC patients. Axalimogene filolisbac has also been
classified as an advanced therapy medicinal product for the
treatment of cervical cancer by the EMA’s CAT. Advaxis has
two additional immunotherapy products: ADXS-PSA in prostate cancer
and ADXS-HER2 in HER2 expressing solid tumors, in human clinical
development. In addition, Advaxis and Amgen are developing
ADXS-NEO, a preclinical investigational cancer immunotherapy
treatment designed to activate a patient's immune system to respond
against the unique mutations, or neoepitopes, contained in and
identified from each individual patient's tumor, with plans to
enter the clinic in 2017.
For additional information on 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 the next generation of cancer
immunotherapies, and the safety and efficacy of Advaxis’
proprietary immunotherapy, axalimogene filolisbac. 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, 2016, which is available at
http://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.
CONTACTS:
Company:
Advaxis, Inc.Ranya Dajani, Vice President,
Business Developmentdajani@advaxis.com609.250.7515
Media Contact:
JPA Health CommunicationsDavid
Connollydconnolly@jpa.com 617.945.9316
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