June 10, 2021 Press release – Regulatory
- Median overall survival (mOS) for first-line treatment with ONCOS-102 plus chemotherapy will be between 21.9 and 25.0 months, compared with mOS of 13.5 months in the chemotherapy-only control group
- Broad and powerful immune activation pattern observed in patients treated with ONCOS-102, clearly associated with both tumor responses and survival outcomes
Oslo, Norway, 10 June 2021 – Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, today announces mOS between 21.9 and 25.0 months from the randomized phase 1/2 trial of ONCOS-102 in combination with Standard of Care (SoC) chemotherapy in patients with malignant pleural mesothelioma (MPM).
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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 second- (or 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 trial has now completed the 24-month follow-up.
At the 24-month follow-up, it was determined that the final mOS will be in the range of 21.9 to 25.0 months for first-line ONCOS-102-treated patients in the randomized group (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 MPM clinical trials have reported mOS in the range of 12–16 months for patients receiving the same SoC chemotherapy treatment.
Immune activation was assessed in tumor biopsies pre- and post-ONCOS-102 treatment (Day 36). The tumor tissue analyses revealed broad and powerful 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. Notably, this activity was associated with both tumor responses and survival outcomes, indicating that the immune activation generated by ONCOS-102 is driving the clinical benefit for patients.
Dr. Luis Paz-Ares, Chair of the Medical Oncology Department at the Hospital Doce de Octubre, Madrid and Principal Investigator of the trial, said: “Mesothelioma remains a challenging disease with a generally poor prognosis, and there is a large unmet medical need for new, innovative treatments such as ONCOS-102. Although the number of patients in this trial is small, the overall survial is very encouraging, particularly since the outcomes can be linked to ONCOS-102-induced immuno-modulation. These early results clearly support further clinical development, and we look forward to participating in future trials with ONCOS-102 in mesothelioma.”
Recently, the double checkpoint inhibitor (CPI) combination of Opdivo and Yervoy (nivolumab and ipilimumab) was approved by the U.S. Food and Drug Administration (October 2020) and the European Medicines Agency (April 2021) for the first-line treatment of MPM, based on a phase 3 trial showing mOS of 18.1 months compared with 14.1 months in the SoC control group (pemetrexed/cisplatin). The Opdivo/Yervoy combination is seeing rapid uptake among clinicians in both the USA and Europe and is becoming the new preferred first-line Standard of Care. Given the class-leading activity ONCOS-102 has demonstrated in CPI-refractory melanoma (see link here), Targovax believes there is a strong scientific rationale for testing ONCOS-102 in the CPI-refractory setting also in MPM. This opportunity is now being discussed with key opinion leaders.
Øystein Soug, CEO of Targovax, commented: “We are very pleased to see ONCOS-102 generating robust immune activation in a tumor type with low immunogenicity and delivering meaningful survival benefit for patients with high medical need. With the recent approval of the Opdivo/Yervoy combination, the power of immunotherapy is now making its way into mesothelioma and is already improving patient outcomes. ONCOS-102 is ideally positioned for combination with checkpoint inhibitors and, as demonstrated in our melanoma trial, to reactivate checkpoint resistant tumors. Therefore, we are now evaluating the potential opportunity in the emerging checkpoint resistant mesothelioma population, thereby expanding on the demonstrated ability of ONCOS-102 to bring benefit to the majority of patients who still progress after checkpoint inhibitor treatment.”
 1 Vogelzang 2003, Ceresoli 2006, Zalcman 2015, Tsao 2019, Scagliotti 2019, Baas 2020 SITC 2020 poster
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 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 products 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 data in several indications, in monotherapy and in multiple combination, the next development steps for ONCOS-102 will involve a clinical trial with registration intent in checkpoint inhibitor refractory melanoma.
This information is considered to be inside information pursuant to the EU Market Abuse Regulation, and is subject to disclosure requirements pursuant to Section 5-12 of the Norwegian Securities Trading Act. The stock exchange announcement was published by Renate Birkeli, Investor Relations, Targovax ASA.