Clinical Performance Study Plan (CPSP) for the use of GenDx CDx Tedopi for subject enrollment on to the OSE Immunotherapeutics Phase 3 trial (OSE2101C302) of OSE2101 versus docetaxel in HLA-A*02 positive patients with metastatic Non-Small Cell Lung Cancer (NSCLC) and secondary resistance to immune checkpoint inhibitor (ARTEMIA)

GenDx have entered into a partnership with OSE Immunotherapeutics (OSE) for the
development of a Companion Diagnostic (CDx), GenDx CDx Tedopi, for use as a
Clinical Trial Assay (CTA) within ARTEMIA study, entitled *A randomized,
open-label, phase 3 trial comparing the efficacy and safety of OSE2101 versus
docetaxel in HLA-A2-positive patients with metastatic Non-Small Cell Lung
Cancer (NSCLC) after secondary resistance to immune checkpoint inhibitors.*
OSE2101 (also known as Tedopi) is a T-specific immunotherapy (cancer
therapeutic vaccine) designed to induce cytotoxic T-lymphocytes (CTLs) against
five tumor associated antigens (TAAs) frequently overexpressed in non-small
cell lung cancer (NSCLC) (i.e., carcinoembryonic antigen [CEA], P53, human
epidermal receptor HER-2/neu, and melanoma antigens MAGE-2 and MAGE-3). OSE2101
is composed of nine synthetic peptides derived from these TAAs and one
universal Helper T Lymphocyte (HTL) peptide (PADRE). The CTL epitopes have been
designed to strongly bind T-cell receptors and HLA-A*02 positive receptors,
therefore OSE2101 use is restricted to subjects with HLA-A*02 positive
phenotype. The HLA-A*02 phenotype is expressed by approximately 45% of the
general population as well as cancer patients [Gragert 2013]. In a prior
controlled study (ATALANTE-1), treatment with OSE2101 statistically improved OS
compared to SoC, was associated with a better safety profile and better Quality
of Life (QoL) in third-line treatment of HLA-A*02 subjects with advanced NSCLC
who had progressive disease (PD) after secondary resistance to anti-PD(L)1 and
first-line platinum-based CT [Besse 2023].
ARTEMIA study is a phase III multicentre, open-label, comparative study of
OSE2101 (Tedopi) versus standard of care (SoC) docetaxel in human leucocyte
antigen HLA-A*02 positive subjects with squamous and non-squamous metastatic
NSCLC in second-line treatment with ICI secondary resistance. The primary
endpoint of the study is overall survival (OS) defined as time from
randomisation to death of any cause. Subjects expressing the HLA-A*02 phenotype
in blood, with metastatic NSCLC in second-line treatment after secondary
resistance to ICI and without a known sensitizing mutation will be eligible to
take part in the ARTEMIA study.
The GenDx CDx Tedopi system will aid in identifying HLA-A*02 positive subjects
who may be eligible for treatment with OSE*s investigational drug OSE2101.

This clinical performance study/clinical investigation will evaluate the safety
and effectiveness of GenDx CDx Tedopi in identifying HLA-A*02 status in
metastatic NSCLC subjects who may be eligible for treatment with OSE2101.

This is an interventional, prospective clinical performance study/clinical
investigation.

Not applicable

Not applicable