OSLO, Norway, Dec. 2, 2020 /PRNewswire/ -- Targovax ASA
(OSE: TRVX), a clinical stage immuno-oncology company developing
immune activators to target hard-to-treat solid tumors, today
announces that the combination of ONCOS-102 and pembrolizumab
(Keytruda) has demonstrated 35% best objective response rate (ORR)
in anti-PD1 refractory malignant melanoma.
In this two-part, open label phase 1 trial the combination of
ONCOS-102 and the anti-PD1 checkpoint inhibitor (CPI) pembrolizumab
has been tested in patients with advanced, unresectable melanoma
who have had disease progression despite treatment with anti-PD1
CPI. This is a particularly challenging patient population, which
is resistant to approved immunotherapies and has few treatment
alternatives available.
For the trial overall, tumor responses were observed in 7 out of
20 evaluable patients treated with the ONCOS-102 and pembrolizumab
combination, translating into an ORR of 35% by RECIST 1.1
criteria.
In addition, there were multiple examples of responses in
non-injected lesions, including 2 patients where a non-injected
lesion completely disappeared, indicating that ONCOS-102 can induce
systemic anti-tumor immunity.
Prof. Jedd Wolchok,
Investigator, Memorial Sloan Kettering Cancer Centre, New York said: "Checkpoint inhibitors have
had a significant impact on the way we treat melanoma; however, a
subset of patients still does not respond or become resistant to
treatment. Therefore, there is a high medical need for immune
activating agents to overcome resistance to checkpoint blockade.
ONCOS-102 is one such agent that can re-sensitize patients to
anti-PD1 therapy. Although these are early data, observing
objective responses with some occurring in non-injected lesions in
this first exploratory phase 1 trial is encouraging, and we will
follow with great interest as ONCOS-102 moves forward into
later-stage development."
The trial was designed with two parts assessing different dosing
regimens. In Part 1, 9 patients were given 3 intra-tumoral
ONCOS-102 injections during the first week, followed by systemic
treatment with pembrolizumab every third week for up to 24 weeks.
As reported in July 2019, preliminary
tumor responses were observed in 3 out of 9 patients in at least
one CT scan (see link here). 1 patient has since been determined as
non-evaluable (trial inclusion criteria not met), and these numbers
have now been updated to 3 out of 8 patients with ORR for Part
1.
12 more patients were enrolled in Part 2 of the trial, where an
extended dosing regimen of 12 intra-tumoral ONCOS-102 injections
was tested; 4 injections during the first two weeks followed by
concomitant administration of ONCOS-102 and pembrolizumab from week
3 and every third week for up to 24 weeks. Tumor responses were
observed in 4 out of the 12 patients in at least one CT scan.
Notably, the patients in Part 2 had markedly more advanced disease
than in Part 1, with the majority diagnosed as stage IV metastatic
melanoma when entering the trial. Importantly, both regimens had
favorable tolerability profiles, with no safety concerns.
These data are very strong compared to other therapies in
development for the same indication in combination with anti-PD1
CPI, including TLR-9 agonists and other oncolytic viruses, which
have reported ORR of ca. 25-30%. As such, the observed ONCOS-102
response rate and effect in non-injected lesions can be considered
class-leading for the treatment of anti-PD1 refractory malignant
melanoma.
Oystein Soug, Chief Executive
Officer of Targovax, commented: "These impressive efficacy data
in anti-PD1 refractory melanoma are the most important clinical
results for Targovax to date. The data clearly confirm our
hypothesis that ONCOS-102 can benefit cancer patients resistant to
checkpoint inhibition by triggering local and systemic immune
activation. They also provide evidence of clinical efficacy and
establishes ONCOS-102 as one of the most promising combination
partners to checkpoint inhibitors. We will now carefully analyze
the immunological data and are planning for a confirmatory melanoma
trial for the ONCOS-102 and checkpoint inhibitor
combination."
The trial (NCT03003676) was conducted at three sites in the US
and one site in Norway, with
Memorial Sloan Kettering CC being the coordinating site.
Online presentation:
Targovax management will present the data in a live webcast
2 December 2020 at 10:00 CET. You can join the webcast here. It will
be possible to ask questions during the presentation. A replay of
the webcast will be available in the Investor section under
"Presentations" after the event.
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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SOURCE Targovax