The company has completed patient enrollment in the phase Ib/II trial of ONCOS-102 in combination with chemotherapy in unresectable malignant pleural mesothelioma (MPM).
The trial consists of a phase Ib safety lead-in part followed by a randomized, open label phase II part, assessing the combination of ONCOS-102 and standard of care (SoC) chemotherapy (pemetrexed and cisplatin) vs SoC chemotherapy alone in first or second/third line patients with unresectable MPM. In May 2018, Targovax reported no safety issues, strong innate and adaptive immune activation and 50% disease control rate (DCR) for the six patients in the phase Ib safety lead-in cohort.
The aim of the trial
The enrollment of 25 patients into the randomized phase II part of the trial has now been completed, with a total of 31 patients on the trial who will be evaluated for safety, immune response and efficacy. There are 20 patients in the experimental arm combining ONCOS-102 with chemotherapy and eleven patients in the chemotherapy only control group. The patients in the part I safety cohort form part of the experimental arm.
The aim of the trial is to assess safety and tolerability, immunological activation and 6-month overall response rate (ORR) of the combination of ONCOS-102 and SoC chemotherapy compared to SoC chemotherapy alone. Data read out is expected around New Year.
“We are very pleased to have completed enrollment of our mesothelioma trial. ONCOS-102 is currently the most clinically advanced oncolytic virus in this difficult to treat cancer, and therefore a high priority for us. The randomized ORR and immune data from this study will indicate whether the ONCOS-102 and chemotherapy combination gives patients a benefit over chemotherapy. The clinical and immune data will guide the further development of ONCOS-102 in mesothelioma,” says Magnus Jäderberg, CMO of Targovax.