The median overall survival (mOS) was 25.0 months in the
first-line group of patients treated with ONCOS-102 plus
chemotherapy, compared with 13.5 months mOS for the
chemotherapy-only control group
OSLO, Norway, Dec. 20, 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 of 25.0 months for treatment with ONCOS-102 in
combination with Standard of Care (SoC) chemotherapy in malignant
pleural mesothelioma (MPM) in the subgroup of patients receiving
therapy in the first-line setting.
The study is an open-label, exploratory phase 1/2 trial adding
ONCOS-102 to SoC chemotherapy (pemetrexed/cisplatin) in first and
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 30-month follow-up has now
been completed.
At the 30-month follow-up, mOS was 25.0 months for the subgroup
of randomized, first-line ONCOS-102-treated patients (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 phase 3 clinical
trials in MPM have reported mOS in the range of 12-16 months for
patients receiving the same SoC chemotherapy treatment in the
first-line setting1. The combination of Opdivo/Yervoy
double checkpoint inhibition was recently approved as a first-line
treatment option for MPM based on a phase 3 trial showing 18.1
months mOS2.
Objective response rate (ORR), progression free survival (PFS)
and mOS have been previously reported, and remain unchanged. The
30-month follow-up analysis completes the mOS data set for all
subgroups in the trial.
Immune activation was assessed in tumor biopsies pre- and
post-ONCOS-102 treatment (Day 0 and Day 36). The tumor tissue
analyses revealed powerful and consistent 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. This
immune activation is associated with tumor responses and is most
pronounced in patients with better survival outcomes, indicating
that the immune activating capacity of ONCOS-102 is driving the
clinical benefit for patients.
Dr. Magnus Jäderberg, Chief Medical Officer of Targovax,
commented: "This excellent survival outcome suggests a great
promise for ONCOS-102 to benefit mesothelioma patients. The results
complement the class-leading ORR and immune activation ONCOS-102
has demonstrated in anti-PD1 resistant melanoma by showing that
ONCOS-102 can be used in combination with both chemotherapy and
anti-PD1 checkpoint inhibition. Importantly, we have confirmed that
ONCOS-102 is active and effective in highly different types of
solid tumors in both early and late lines of therapy. Based on the
encouraging patient outcomes and deep mechanistic analysis from the
phase 1/2 program, we are currently designing and preparing for the
next phase in ONCOS-102 clinical development."
1 Vogelzang 2003, Ceresoli 2006, Zalcman 2015, Tsao 2019,
Scagliotti 2019, Baas 2020 SITC 2020 poster
2 Baas et al. The Lancet, 2021
For further information, please contact:
Erik Digman Wiklund, CEO
Phone: +47 413 33 536
Email: erik.wiklund@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
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