On May 8, 2019 Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, reported that it has completed patient enrollment in the phase Ib/II trial of ONCOS-102 in combination with chemotherapy in unresectable malignant pleural mesothelioma (MPM) (Press release, Targovax, MAY 8, 2019, View Source [SID1234535856]).

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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 – see link to press release here.

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.

Magnus Jäderberg, CMO of Targovax, said: "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."