The median overall survival (mOS) was 25.0 months in the first-line group of patients treated with ONCOS-102 plus chemotherapy, compared with 13.5 months mOS for the chemotherapy-only control group
Oslo, Norway, 20 December 2021 – Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, today announces 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.
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.”
1 Vogelzang 2003, Ceresoli 2006, Zalcman 2015, Tsao 2019, Scagliotti 2019, Baas 2020 SITC 2020 poster
2 Baas et al. The Lancet, 2021
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Activating the patient's immune system to fight cancer
Targovax (OSE:TRVX) is a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors. Targovax aims to unlock greater clinical benefits in cancer patients by deploying its multifunctional platforms to target key immune regulators and oncogenic drivers. Targovax’s focus is to “activate the patient’s immune system to fight cancer”, thus extending and transforming the lives of cancer patients. Targovax’s pipeline aims at different cancer indications, including melanoma, mesothelioma and colorectal cancer. The company’s product candidates are designed to harness the patient’s own immune system to fight the cancer, whilst also delivering a favorable safety and tolerability profile.
Targovax’s lead clinical candidate, ONCOS-102, is a genetically modified oncolytic adenovirus, which has been engineered to selectively infect cancer cells and activate the immune system to fight the cancer. On the back of very encouraging clinical data in several indications, both in monotherapy and in multiple combinations, the next development steps for ONCOS-102 will be to further improve responses in melanoma patients resistant to or poorly responsive to current standard of care.