- Median overall survival (mOS) for first-line treatment with
ONCOS-102 plus chemotherapy will be between 21.9 and 25.0 months,
compared with mOS of 13.5 months in the chemotherapy-only control
group
- Broad and powerful immune activation pattern observed in
patients treated with ONCOS-102, clearly associated with both tumor
responses and survival outcomes
OSLO, Norway, June 10, 2021 /PRNewswire/ -- Targovax
ASA (OSE: TRVX), a clinical-stage immuno-oncology company
developing immune activators to target hard-to-treat solid tumors,
today announces mOS between 21.9 and 25.0 months from the
randomized phase 1/2 trial of ONCOS-102 in combination with
Standard of Care (SoC) chemotherapy in patients with malignant
pleural mesothelioma (MPM).
For information in Norwegian,press this link.
The study is an open-label, exploratory phase 1/2 trial adding
ONCOS-102 to SoC chemotherapy (pemetrexed/cisplatin) in first- and
second- (or later) line MPM to assess safety, immune activation and
clinical efficacy compared with SoC alone. A total of 31 patients
were enrolled in the trial, with 20 patients in the treatment group
receiving ONCOS-102 plus SoC chemotherapy, and 11 patients in the
control group receiving SoC only. The trial has now completed the
24-month follow-up.
At the 24-month follow-up, it was determined that the final mOS
will be in the range of 21.9 to 25.0 months for first-line
ONCOS-102-treated patients in the randomized group (n=8). This is a
clear improvement over the mOS of 13.5 months observed in the
first-line SoC-only control group (n=6). Previous MPM clinical
trials have reported mOS in the range of 12–16 months for
patients receiving the same SoC chemotherapy
treatment[1].
Immune activation was assessed in tumor biopsies pre- and
post-ONCOS-102 treatment (Day 36). The tumor tissue analyses
revealed broad and powerful ONCOS-102-induced remodeling of the
tumor microenvironment with increased T-cell infiltration and a
shift towards pro-inflammatory immune cells, far beyond what was
observed for the SoC-only control group. Notably, this activity was
associated with both tumor responses and survival outcomes,
indicating that the immune activation generated by ONCOS-102 is
driving the clinical benefit for patients.
Dr. Luis Paz-Ares, Chair of
the Medical Oncology Department at the Hospital Doce de Octubre,
Madrid and Principal Investigator
of the trial, said: "Mesothelioma remains a challenging
disease with a generally poor prognosis, and there is a large unmet
medical need for new, innovative treatments such as ONCOS-102.
Although the number of patients in this trial is small, the overall
survial is very encouraging, particularly since the outcomes can be
linked to ONCOS-102-induced immuno-modulation. These early results
clearly support further clinical development, and we look forward
to participating in future trials with ONCOS-102 in
mesothelioma."
Recently, the double checkpoint inhibitor (CPI) combination of
Opdivo and Yervoy (nivolumab and ipilimumab) was approved by the
U.S. Food and Drug Administration (October
2020) and the European Medicines Agency (April 2021) for the first-line treatment of MPM,
based on a phase 3 trial showing mOS of 18.1 months compared with
14.1 months in the SoC control group (pemetrexed/cisplatin). The
Opdivo/Yervoy combination is seeing rapid uptake among clinicians
in both the USA and Europe and is becoming the new preferred
first-line Standard of Care. Given the class-leading activity
ONCOS-102 has demonstrated in CPI-refractory melanoma (see link
here), Targovax believes there is a strong scientific rationale for
testing ONCOS-102 in the CPI-refractory setting also in MPM. This
opportunity is now being discussed with key opinion leaders.
Øystein Soug, CEO of Targovax, commented: "We are
very pleased to see ONCOS-102 generating robust immune activation
in a tumor type with low immunogenicity and delivering meaningful
survival benefit for patients with high medical need. With the
recent approval of the Opdivo/Yervoy combination, the power of
immunotherapy is now making its way into mesothelioma and is
already improving patient outcomes. ONCOS-102 is ideally positioned
for combination with checkpoint inhibitors and, as demonstrated in
our melanoma trial, to reactivate checkpoint resistant tumors.
Therefore, we are now evaluating the potential opportunity in the
emerging checkpoint resistant mesothelioma population, thereby
expanding on the demonstrated ability of ONCOS-102 to bring benefit
to the majority of patients who still progress after checkpoint
inhibitor treatment."
[1] 1 Vogelzang 2003, Ceresoli 2006, Zalcman
2015, Tsao 2019, Scagliotti 2019, Baas 2020 SITC 2020 poster
For further information, please contact:
Øystein Soug, CEO
Phone: +47 906 56 525
Email: oystein.soug@targovax.com
Renate Birkeli, Investor
Relations
Phone: +47 922 61 624
Email: renate.birkeli@targovax.com
Media enquires:
Andreas Tinglum - Corporate
Communications (Norway)
Phone: +47 9300 1773
Email: andreas.tinglum@corpcom.no
IR enquires:
Kim Sutton Golodetz - LHA
Investor Relations (US)
Email: kgolodetz@lhai.com
Phone: +1 212-838-3777
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/targovax/r/targovax-s-oncos-102-mesothelioma-24-month-data-shows-class-leading-median-overall-survival,c3364714
The following files are available for download:
https://mb.cision.com/Public/17093/3364714/b95e6ec6e1a750da.pdf
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