- Encouraging PFS and survival data in ONCOS-102-treated first
line patients as 31 patients have now completed 12 months
follow-up
- Mechanistic evidence of profound immune activation in
ONCOS-102-treated patients associated with better clinical
outcomes
- Immune activation data provides clear scientific rationale for
anti-PD1/L1 checkpoint inhibitor combination in upcoming trial in
first line mesothelioma
OSLO, Norway, June 22, 2020 /PRNewswire/ -- Targovax ASA
(OSE: TRVX), a clinical stage immuno-oncology company developing
oncolytic viruses to target hard-to-treat solid tumors, today
releases 12-month efficacy and immunological data from the
randomized phase I/II trial of ONCOS-102 in combination with
standard of care chemotherapy in malignant pleural mesothelioma
(MPM).
The trial is an open label, exploratory phase I/II trial adding
ONCOS-102 to standard of care (SoC) chemotherapy
(pemetrexed/cisplatin) in first and second (and later) line MPM to
assess safety, immune activation and clinical efficacy vs SoC only.
In total, 31 patients have been treated in the trial, with 20
patients in the experimental group receiving the ONCOS-102 and SoC
combination, and 11 patients in a control group receiving SoC only.
The 31 patients have now completed the 12-month follow-up. The
first set of data was reported in January
2020, see press release here, with an update in May 2020, see press release here.
The median Progression Free Survival (mPFS) for ONCOS-102
treated first line patients remains at 8.9 months, which is
identical to the previously reported early data. mPFS for the
control group first line patients treated with SoC chemotherapy
only is 7.6 months. The first line mPFS data continues to compare
favorably to SoC historical controls, which have shown mPFS of
5.7-7.3 months[1]. As there is now longer follow-up and
few censored patients left in the PFS analysis, the updated figures
can be considered close to final.
The 12-month survival rate was 64% in the first line ONCOS-102
treated patients, compared to 50% in the first line control group
treated with SoC chemotherapy only (median Overall Survival is too
early to report). The patients continue to be followed and updated
Overall Survival (OS) figures will be published as they mature.
This 64% 12-month survival rate is encouraging compared to the
control group, but there are few historical control reference
points. Recently, at ASCO 2020, results from a first line
mesothelioma trial assessing SoC chemotherapy in combination with
the anti-PD-L1 checkpoint inhibitor durvalumab showed a 70%
12-month survival rate. This suggests that ONCOS-102 alone plus SoC
chemotherapy may already achieve a level of benefit close to that
observed with checkpoint inhibition plus SoC chemotherapy. It is
expected that addition of checkpoint inhibition to ONCOS-102 and
Soc will provide even further clinical benefit due to engagement of
distinct and complementary biological mechanisms. As such,
Targovax's future clinical development of ONCOS-102 will focus on
first line mesothelioma with the triple combination of a checkpoint
inhibitor, ONCOS-102 and SoC. A randomized phase II trial is
currently being planned in collaboration with a pharma partner.
Tumor biopsy immunohistochemistry and gene expression analyses
from the present trial confirm the predicted mode of action of
ONCOS-102. Importantly, profound innate and adaptive immune
activation is observed in the ONCOS-102 treated patients compared
to the control group, and this immune activation is associated with
better clinical outcome. The immune activation is hallmarked by an
increase in intra-tumoral cytotoxic T-cells and upregulation of
adaptive immunity and cytotoxicity related gene expression, in
parallel with polarization from M2 to M1 macrophage phenotype and
upregulation of PD-L1 expression, indicating that ONCOS-102 is
driving a favorable remodeling of the tumor microenvironment. This
powerfully demonstrates the immune activation potential of
ONCOS-102 far beyond what is achieved by chemotherapy alone and
suggests that patients may be effectively sensitized to treatment
with an anti-PD1/L1 antagonist, thereby providing strong scientific
rationale for the combination of ONCOS-102 and checkpoint
inhibition in first line mesothelioma.
Dr. Magnus Jäderberg, Chief Medical Officer of Targovax,
said: "We are very pleased to see the encouraging first line
PFS data holding up in the 12-month analysis, with early signs of
positive survival outcomes. We are particularly excited to observe
a broad and profound immune activation in the ONCOS-102 treated
patients, which confirms the proposed mode of action. ONCOS-102
treatment clearly drives a favorable remodeling of the tumor
microenvironment, and this remodeling is linked to better clinical
outcomes. This immune activated tumor micro-environment provides
the key scientific rationale and an ideal backdrop for combination
treatment with a checkpoint inhibitor. These data set us up
perfectly to move forward with a trial combining ONCOS-102 and a
checkpoint inhibitor, which we believe will release the full
potential of immunotherapy in this hard-to-treat patient
population".
For a video presentation of the data, please see links
below:
- English version Magnus Jäderberg, Chief Medical Officer
- Norwegian version Erik Digman
Wiklund, Cheif Business Officer
[1] Vogelzang 2003, Ceresoli 2006, Zalcman 2015,
Tsao 2019, Scagliotti 2019
CONTACT:
For further information, please contact:
Renate Birkeli
Investor Relations
Phone: +47-922-61-624
Email: renate.birkeli@targovax.com
Media and IR enquires:
Andreas Tinglum
Corporate Communications (Norway)
Phone: +47-9300-1773
Email: andreas.tinglum@corpcom.no
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