- 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.
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