The company announces results from its phase I/II trial of ONCOS-102 in mesothelioma, in combination with standard of care chemotherapy, in which clinical responses were observed in three out of the first six patients.
The trial is a randomized phase I/II open label trial, with a six-patient safety lead-in cohort, of ONCOS-102 and pemetrexed/cisplatin, the current standard of care chemotherapy, in patients with unresectable malignant pleural mesothelioma. The aim of the trial is to assess safety and tolerability, immunological activation and overall response rate of the combination of ONCOS-102 and chemotherapy compared to chemotherapy alone. In February, Targovax reported that the independent Data and Safety Monitoring Board (DSMB) had assessed the safety data from the lead-in cohort, and recommended the trial continue into the randomized phase without modifications. In addition, innate and adaptive immune activation was observed in the first patients analyzed.
Overall response rate
Now, overall response rate has been evaluated for all six patients in the safety cohort after six months. Three out of the six patients (50%) responded, with one patient showing a partial response and two patients showing stable disease, according to the Response Evaluation Criteria In Solid Tumors guidelines, RECIST 1.1.
All patients in the safety cohort received ONCOS-102 and chemotherapy combination treatment either as 1st line (three patients), or after previous treatment (three patients, 2nd/3rd line). Two out of three patients in 1st line responded, and one of three patients that had received previous treatment responded.
Based on this early signal of efficacy, and the previous DSMB recommendation, recruitment into the randomized part of the trial is now underway. The trial will include 30 patients when fully recruited, with 20 patients in the experimental group (including the safety cohort) and 10 patients in the control group.
