- The pre-defined disease control efficacy threshold in part 1
in the colorectal cancer cohort has been met
- The colorectal expansion cohort has been opened for
recruitment of 14 additional patients
- The pre-defined disease control efficacy threshold in ovarian
cancer was not met and this cohort will be closed for
enrollment
OSLO, Norway, Oct. 13, 2020 /PRNewswire/ -- Targovax ASA
(OSE: TRVX), a clinical stage immuno-oncology company developing
oncolytic viruses to target hard-to-treat solid tumors, today
announced that the colorectal cancer cohort in part 1 of the
ONCOS-102 and durvalumab trial in colorectal and platinum-resistant
ovarian cancer that has spread to the peritoneum has met the
pre-defined efficacy threshold of patients without progression at
the end of week 24. The second part of the colorectal expansion
cohort is now open for recruitment.
The study is an open label, exploratory phase I/II trial
assessing the combination of intra-peritoneally delivered ONCOS-102
in combination with systemically administered durvalumab, an
anti-PD-L1 checkpoint inhibitor, in patients with colorectal (CRC)
or platinum-resistant ovarian (OC) cancers that have metastasized
to the peritoneal cavity. The trial is designed with a
dose-escalation phase assessing three different dosing levels,
followed by an expansion phase split into separate CRC and OC
cohorts. The expansion phase is divided into two parts, where the
second part is opened only if a pre-defined efficacy threshold is
met in the first part. The efficacy threshold in the CRC cohort is
1 out of 13 patients and 5 out of 18 patients in the OC cohort
without progression at week 24.
Ludwig Cancer Research, the trial sponsor, and the investigators
have reviewed the available data in part 1 of the expansion phase
and concluded that the threshold has been met in the CRC cohort.
The second part of the CRC cohort has therefore been opened for
recruitment with the aim of enrolling 14 additional patients. For
OC, threshold was not met, and this cohort has been closed for
further recruitment.
Dr. Dmitriy Zamarin, Medical
Oncologist at Memorial Sloan Kettering Cancer Center (MSK),
Investigator at the Ludwig Center at MSK and Principal Investigator
of the study, said: "Chemotherapy-resistant
microsatellite-stable colorectal cancer is a challenging disease to
treat, with a response rate to immune checkpoint inhibitor
monotherapy of less than 5%. We are hopeful that the immune
activation by ONCOS-102 in peritoneal cavity may sensitize these
tumors to immune checkpoint inhibition and improve this response
rate."
Dr. Magnus Jäderberg, Chief Medical Officer of Targovax,
said: "The first part of the trial has allowed us to determine
which primary cancer holds most promise for future development of
ONCOS-102 in the intra-peritoneal setting. We are very pleased to
see that the efficacy threshold has been met for the CRC cohort,
and will now focus exclusively on this patient population of
primary, platinum-resistant CRC with peritoneal metastases for the
second part of the trial. This is a large patient group with no
effective available treatment alternatives today, and we are
hopeful that this novel combination of immunotherapies can deliver
benefit in this disease with very high unmet medical need."
The trial is a collaboration between Targovax, AstraZeneca
(LSE/STO/Nasdaq: AZN), Cancer Research Institute (CRI) and Ludwig
Cancer Research.
Follow this link to see the updated company presentation.
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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