On December 20, 2021 Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that mOS of 25.0 months for treatment with ONCOS-102 in combination with Standard of Care (SoC) chemotherapy in malignant pleural mesothelioma (MPM) in the subgroup of patients receiving therapy in the first-line setting (Press release, Targovax, DEC 20, 2021, View Source [SID1234597439]).

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The study is an open-label, exploratory phase 1/2 trial adding ONCOS-102 to SoC chemotherapy (pemetrexed/cisplatin) in first and later line MPM to assess safety, immune activation and clinical efficacy compared with SoC alone. A total of 31 patients were enrolled in the trial, with 20 patients in the treatment group receiving ONCOS-102 plus SoC chemotherapy, and 11 patients in the control group receiving SoC only. The 30-month follow-up has now been completed.

At the 30-month follow-up, mOS was 25.0 months for the subgroup of randomized, first-line ONCOS-102-treated patients (n=8). This is a clear improvement over the mOS of 13.5 months observed in the first-line SoC-only control group (n=6). Previous phase 3 clinical trials in MPM have reported mOS in the range of 12-16 months for patients receiving the same SoC chemotherapy treatment in the first-line setting1. The combination of Opdivo/Yervoy double checkpoint inhibition was recently approved as a first-line treatment option for MPM based on a phase 3 trial showing 18.1 months mOS2.

Objective response rate (ORR), progression free survival (PFS) and mOS have been previously reported, and remain unchanged. The 30-month follow-up analysis completes the mOS data set for all subgroups in the trial.

Immune activation was assessed in tumor biopsies pre- and post-ONCOS-102 treatment (Day 0 and Day 36). The tumor tissue analyses revealed powerful and consistent ONCOS-102-induced remodeling of the tumor microenvironment with increased T-cell infiltration and a shift towards pro-inflammatory immune cells, far beyond what was observed for the SoC-only control group. This immune activation is associated with tumor responses and is most pronounced in patients with better survival outcomes, indicating that the immune activating capacity of ONCOS-102 is driving the clinical benefit for patients.

Dr. Magnus Jäderberg, Chief Medical Officer of Targovax, commented: "This excellent survival outcome suggests a great promise for ONCOS-102 to benefit mesothelioma patients. The results complement the class-leading ORR and immune activation ONCOS-102 has demonstrated in anti-PD1 resistant melanoma by showing that ONCOS-102 can be used in combination with both chemotherapy and anti-PD1 checkpoint inhibition. Importantly, we have confirmed that ONCOS-102 is active and effective in highly different types of solid tumors in both early and late lines of therapy. Based on the encouraging patient outcomes and deep mechanistic analysis from the phase 1/2 program, we are currently designing and preparing for the next phase in ONCOS-102 clinical development."