- An 18-month analysis shows that median Overall Survival (mOS)
will be at least 18.2 months for first-line patients receiving
ONCOS-102 plus chemotherapy, compared to mOS of 14.2 months or less
in the chemotherapy-only control group
- ONCOS-102-treated patients show broad and powerful immune
activation, associated with better survival outcome
OSLO, Norway, Nov. 24, 2020 /PRNewswire/ -- Targovax
ASA (OSE: TRVX), a clinical stage immuno-oncology company
developing oncolytic viruses to target hard-to-treat solid tumors,
today releases 18-month follow-up data from the randomized phase
I/II trial of ONCOS-102 in combination with standard-of-care (SoC)
chemotherapy in patients with malignant pleural mesothelioma
(MPM).
The study is an open-label, exploratory phase I/II trial adding
ONCOS-102 to SoC chemotherapy (pemetrexed/cisplatin) in first- and
second- (and later) line treatment of MPM to assess safety, immune
activation and efficacy versus SoC only. In total, 31 patients have
been included in the trial, with 20 patients in the experimental
group receiving the ONCOS-102 and SoC combination (8 randomized in
first-line), and 11 patients in the control group receiving SoC
only (6 in first-line).
At the 18-month follow-up, more than half of the patients in the
first-line ONCOS-102-treated group were still alive, and the mOS
was not yet reached. Based on current survival data the mOS will be
18.2 months or longer. For the first-line SoC-only control group,
less than half of the patients were alive, and mOS will be 14.2
months or less, which is similar to outcomes from previously
reported trials where patients received the same chemotherapy
treatment1. An analysis of all the first-line patients,
including 3 experimental safety lead-in patients, shows similar
results as the randomized first-line patients. The next survival
analysis is planned in first half of 2021.
In June, it was reported that ONCOS-102 treatment induces broad
and powerful immune activation in MPM, far beyond what is achieved
with SoC alone. Importantly, this immune activation is associated
with better survival outcomes at the 18-month analysis, indicating
that the immunological activity of ONCOS-102 drives the observed
clinical benefit.
The powerful immune activation generated by ONCOS-102 builds a
strong rationale for combining ONCOS-102 with a checkpoint
inhibitor in MPM. This combination could provide further clinical
benefits in this indication. Targovax and Merck (known as MSD
outside of the USA) are currently
reviewing next steps for combining ONCOS-102 and pembrolizumab
(Keytruda) in MPM. Recently, the U.S. Food and Drug Administration
(FDA) approved the combination of ipilimumab and nivolumab (Yervoy
and Opdivo) for the first-line treatment of MPM based on mOS of
18.1 months (Baas 2020), and this is expected to serve as a
benchmark for further approvals.
Magnus Jäderberg, Chief Medical Officer of Targovax,
said: "We are very pleased that overall survival in first-line
patients, is tracking well in the ONCOS-102 treated group. We have
already established in the current study that ONCOS-102 drives
favorable remodeling of the tumor microenvironment, and we are now
starting to see this immune activation translating into the
encouraging improved survival outcomes in these 18-month results.
This is exactly what we had hoped to see and prepares the way for
combining ONCOS-102 with checkpoint inhibition. The immune
data suggest to us that survival outcomes in combination with
Keytruda may be further improved from the results reported
today."
The first results from the trial were announced in January 2020 (see press release here), while
immunological data and 12-month survival rate were reported in
June 2020 (see press release here)
and presented at the SITC annual meeting in November 2020 (see
poster here).
References
1Vogelzang 2003, Ceresoli 2006, Zalcman 2015, Tsao
2019, Scagliotti 2019, Baas 2020 SITC 2020 poster
CONTACT:
For further information, please contact:
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
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