STRASBOURG, France--(BUSINESS WIRE)--Regulatory News:
Transgene (Paris:TNG) (Euronext Paris: TNG), a biotechnology company that designs and develops virus-based immunotherapies, announces the dosing of the first patient in the Phase 2 trial evaluating TG4010 in combination with Opdivo® (nivolumab) and chemotherapy as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) with low or no expression of PD-L1 by the tumor cells.
The Phase 2 clinical trial is exploring the tolerability and efficacy of
the combination regimen of Transgene’s TG4010, an investigational active
immunotherapy against MUC1 tumor-associated antigen, with Bristol-Myers
Squibb’s immune checkpoint inhibitor, Opdivo® (nivolumab), which acts by
overcoming immune suppression, and standard platinum doublet
chemotherapy.
This multi-center single-arm trial will enroll up to
39 patients (without EGFR activating mutations or ALK-rearrangements),
both in the USA and Europe. The trial has objective tumor responses rate
(ORR) as primary endpoint. The study will also assess the safety and
tolerability of the regimen together with other efficacy and
immunological parameters. The first results are expected in H2 2018.
More
information on the trial can be found on clinicaltrial.gov (NCT03353675).
This
trial is conducted by Transgene under a clinical collaboration agreement
with Bristol-Myers Squibb, which is supplying nivolumab (see press
release dated April 25, 2017).
“Advanced lung cancer remains a devastating disease, in particular for patients whose tumors express low or undetectable levels of PD-L1. We are excited to start a trial that combines our active immunotherapy TG4010, with nivolumab and chemotherapy as a first-line treatment” said Maud Brandely, Chief Medical Officer of Transgene. “We believe that this trial could confirm the promising efficacy data that we previously obtained with TG4010 in combination with chemotherapy, and show that the triple regimen could be an attractive treatment option in this patient population.”
Elisabeth Quoix, M.D., Head of the Department of Pulmonology at the University Hospital of Strasbourg, and coordinating investigator of the trial, added: “The three complementary mechanisms of action of TG4010, nivolumab and chemotherapy are believed to enhance the immune cellular response and lead to an increase in antitumor activity. This combination regimen aims at achieving a higher response rate, and ultimately an improvement in the survival rate in advanced-stage NSCLC patients.”
The combination of TG4010 immunotherapy and chemotherapy has demonstrated significant efficacy in terms of increased response rate, progression-free survival and overall survival in a randomized, double-blind, placebo-controlled Phase 2b trial in first-line treatment of patients with advanced non-squamous NSCLC (Quoix et al. Lancet Oncol. 2015).
About TG4010
TG4010 is an active immunotherapy that
has been designed to express the coding sequences of the MUC1
tumor-associated antigen and the cytokine, Interleukin-2 (IL2). It is
based on a modified Vaccinia virus (MVA), and has been shown to
induce an immune response against MUC1 expressing tumors, such as
non-small cell lung cancer (NSCLC). Its mechanism of action and
excellent safety profile make TG4010 a very suitable candidate for
combinations with other therapies, including immune checkpoint
inhibitors and chemotherapy. The combination of TG4010 immunotherapy and
chemotherapy has demonstrated significant efficacy in terms of
progression-free survival and overall survival in patients with advanced
stage NSCLC (Quoix et al. Lancet
Oncol. 2015).
TG4010 is being investigated in combination with
nivolumab (ICI) for the 2nd-line treatment of advanced NSCLC (NCT02823990)
and for 1st-line treatment of NSCLC in combination with
nivolumab and chemotherapy in patients whose tumors express low or
undetectable levels of PD-L1 (NCT03353675).
About Non-Small Cell Lung Cancer
Lung cancer is one
of the most common malignancies worldwide with an estimated 1.8 million
new cases annually. It is also a leading cause of cancer-related deaths,
accounting for an estimated 1.6 million deaths in 2012 (Source:
GLOBOCAN 2012). Advanced lung cancer remains one of the cancer types
with the worst prognosis (five-year survival rate for advanced NSCLC of
less than 5%), underlining the still unmet need in this disease despite
recent progress.
About Transgene
Transgene (Euronext: TNG), part of
Institut Mérieux, is a publicly traded French biotechnology company
focused on designing and developing targeted immunotherapies for the
treatment of cancer and infectious diseases. Transgene’s programs
utilize viral vector technology with the goal of indirectly or directly
killing infected or cancerous cells. The Company’s lead clinical-stage
programs are: TG4010, a therapeutic vaccine against non-small cell lung
cancer, Pexa-Vec, an oncolytic virus against liver cancer, and TG4001, a
therapeutic vaccine against HPV-positive head and neck cancers. The
Company has several other programs in clinical development, including
TG1050 (chronic hepatitis B) and TG6002 (solid tumors). Transgene is
based in Strasbourg, France, and has additional operations in Lyon, as
well as a joint venture in China.
Additional information about
Transgene is available at www.transgene.fr.
Follow
us on Twitter: @TransgeneSA
Disclaimer
This press release contains
forward-looking statements, which are subject to numerous risks and
uncertainties, which could cause actual results to differ materially
from those anticipated. The occurrence of any of these risks could have
a significant negative outcome for the Company’s activities,
perspectives, financial situation, results, regulatory authorities’
agreement with development phases, and development. The Company’s
ability to commercialize its products depends on but is not limited to
the following factors: positive pre-clinical data may not be predictive
of human clinical results, the success of clinical studies, the ability
to obtain financing and/or partnerships for product manufacturing,
development and commercialization, and marketing approval by government
regulatory authorities. For a discussion of risks and uncertainties
which could cause the Company’s actual results, financial condition,
performance or achievements to differ from those contained in the
forward-looking statements, please refer to the Risk Factors (“Facteurs
de Risques”) section of the Document de Référence, available on the AMF
website (http://www.amf-france.org)
or on Transgene’s website (www.transgene.fr).
Forward-looking statements speak only as of the date on which they are
made and Transgene undertakes no obligation to update these
forward-looking statements, even if new information becomes available in
the future.
Opdivo® is a registered trademark of Bristol-Myers Squibb Company.
