Precision-Panc Team Open the PRIMUS-006 Study, a Novel Combination of IMM-101, Gemcitabine and Pembrolizumab
2024年6月18日 - 4:00PM
The Precision-Panc team at the University of Glasgow, with their
Co-Sponsor, NHS Greater Glasgow & Clyde, today announced the
opening of the Phase II PRIMUS-006 study evaluating IMM-101, a
broad-spectrum immunomodulatory agent containing heat-killed, whole
cell Mycobacterium obuense, in combination with gemcitabine and
pembrolizumab as first-line treatment in patients with metastatic
pancreatic cancer. The PRIMUS-006 study is part of the
Precision-Panc Platform master protocol program, which is
Co-Sponsored by NHS Greater Glasgow & Clyde and the University
of Glasgow and co-ordinated by the Glasgow Oncology Clinical Trials
Unit. PRIMUS-006 is endorsed by Cancer Research UK (CRUK Reference:
A31505). The study is funded by Merck Sharp & Dohme LLC., a
subsidiary of Merck & Co., Inc., Rahway, NJ, U.S.A., through
its investigator-initiated program with provision of study drug and
financial support. The study is also funded by Immodulon
Therapeutics Ltd through its investigator-initiated program with
provision of study drug and financial support for the study.
“The opening of the Phase II PRIMUS-006 study is
an important milestone in the pursuit to develop new treatment
options to improve the overall outcomes in patients diagnosed with
pancreatic cancer,” said Professor David Chang, principal
investigator and professor of surgical oncology & honorary
consultant pancreatic surgeon, Wolfson Wohl Cancer Research Centre,
University of Glasgow and Glasgow Royal Infirmary. “The selection
of IMM-101 to comprise part of the triplet combination reflects its
potential to enhance anti-tumour activity alongside gemcitabine and
pembrolizumab in patients with first-line metastatic pancreatic
cancer,” said Professor Jeff Evans of the University of Glasgow and
Honorary Consultant in Medical Oncology at the Beatson West of
Scotland Cancer Centre, Glasgow.
Pancreatic ductal adenocarcinoma (PDAC) tends to
be poorly immunogenic with diminished antigen presentation and a
highly immunosuppressive tumour micro-environment that further
impedes the functional activation of cytotoxic T lymphocytes. Based
on the ability of gemcitabine to enhance the expression of
antigen-presenting molecules, its use in combination with IMM-101,
a broad-spectrum immunomodulator with potential to sensitize
pancreatic cancers to immune checkpoint inhibition, and
pembrolizumab, MSD’s anti-PD-1 therapy, this novel combination has
the potential to enhance anti-tumour efficacy in patients with
first-line pancreatic cancer.
“This is an exciting opportunity to be part of a
high caliber pancreatic cancer research program and reflects the
potential of IMM-101 to become a backbone therapy in
immunologically cold tumours by enhancing the efficacy of existing
anti-cancer treatment options, including chemotherapy and
checkpoint inhibitors,” said Josefine Roemmler-Zehrer, MD,
Associate Professor, and Chief Medical Officer of Immodulon. “We
look forward to working with the Co-Sponsors NHS Greater Glasgow
& Clyde and University of Glasgow, MSD and other key
collaborators to support this study and advance our efforts to
bring IMM-101 closer to patients diagnosed with pancreatic cancer
and other solid tumours.”
The Phase II PRIMUS-006 study is a single-arm
clinical study evaluating IMM-101, gemcitabine and pembrolizumab as
first-line combination triplet therapy in patients diagnosed with
metastatic pancreatic cancer who are deemed not sufficiently fit
enough to tolerate treatment consisting of two or more cytotoxic
agents. As the overall objective of the study is to enhance the
anti-tumour activity of immunotherapy, the primary endpoint of the
study is the objective response rate as defined by RECIST 1.1. Key
secondary endpoints include safety and tolerability, evaluation of
progression-free survival, disease control rate and overall
survival. Up to 50 patients with metastatic pancreatic ductal
adenocarcinoma will be treated in the study from approximately
15-20 hospital sites in the United Kingdom.
About Pancreatic Ductal Adenocarcinoma
(PDAC)PDAC is the third most common cause of cancer death
in the developed world. Approximately 50% of patients present with
metastatic disease and most of the patients who present with
resectable or locally advanced inoperable disease ultimately
develop metastatic disease. Gemcitabine monotherapy has modest
clinical benefit and a marginal survival advantage in patients with
metastatic PDAC. Better response rates and survival can be achieved
with the FOLFIRINOX regimen, and with the addition of
nab-paclitaxel to gemcitabine. Nevertheless, overall survival
remains disappointing with these combination cytotoxic chemotherapy
regimens. Furthermore, many patients are not fit enough to tolerate
these combination regimens, and these patients are invariably
excluded from participation in clinical trials because of lower
performance status. Consequently, these patients represent a
significant unmet clinical need and are in urgent need of novel
therapeutic approaches.
About IMM-101IMM-101 is a
systemic, broad-spectrum immunomodulator containing heat-killed,
whole cell Mycobacterium obuense, capable of generating a broad
systemic innate and adaptive type 1 immune response with potential
to treat immunologically ‘cold’ cancers, like pancreatic cancer. In
the Phase II IMAGE-1 Study of IMM-101 in combination with
gemcitabine, clinical data indicate that IMM-101 is well-tolerated
and effective and that it has the potential as a first-line
treatment to prolong progression-free survival in patients with
advanced pancreatic ductal adenocarcinoma (PDAC) when compared to
gemcitabine alone. The study data also suggest a beneficial effect
on survival in patients with metastatic PDAC. Immodulon is
currently prioritizing the initiation of a Bayesian adaptive
pivotal study for IMM-101 in PDAC that can be expanded to evaluate
IMM-101 in other immunologically ‘cold’ tumours across multiple
parallel arms.
About
Precision-PancPrecision-Panc aims to establish a mechanism
and framework to recruit and screen patients with pancreatic cancer
to perform molecular profiling and evaluation of circulating
biomarkers and to enable enrollment in clinical studies to
accelerate therapeutic development for pancreatic cancer. The
PRIMUS studies are a series of clinical trials with novel design to
answer specific therapeutic questions and parallel biomarker
studies. The Precision-Panc Platform is a way to accelerate
stratified therapeutic development through a combination of
pre-clinical work, clinical trials, and discovery. As part of the
platform there will be a suite of clinical trials, with the aim to
have a trial for each indication of pancreatic cancer in the
future. For more information, please visit
www.precisionpanc.org.
Contacts:
Josh Rappaport and William GramigPrecision
AQjosh.rappaport@precisionaq.comwilliam.gramig@precisionaq.com