- An 18-month analysis shows that median Overall Survival (mOS) will be at least 18.2 months for first-line patients receiving ONCOS-102 plus chemotherapy, compared to mOS of 14.2 months or less in the chemotherapy-only control group
- ONCOS-102-treated patients show broad and powerful immune activation, associated with better survival outcome
OSLO, Norway, Nov. 24, 2020 /PRNewswire/ -- Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, today releases 18-month follow-up data from the randomized phase I/II trial of ONCOS-102 in combination with standard-of-care (SoC) chemotherapy in patients with malignant pleural mesothelioma (MPM).
The study is an open-label, exploratory phase I/II trial adding ONCOS-102 to SoC chemotherapy (pemetrexed/cisplatin) in first- and second- (and later) line treatment of MPM to assess safety, immune activation and efficacy versus SoC only. In total, 31 patients have been included in the trial, with 20 patients in the experimental group receiving the ONCOS-102 and SoC combination (8 randomized in first-line), and 11 patients in the control group receiving SoC only (6 in first-line).
At the 18-month follow-up, more than half of the patients in the first-line ONCOS-102-treated group were still alive, and the mOS was not yet reached. Based on current survival data the mOS will be 18.2 months or longer. For the first-line SoC-only control group, less than half of the patients were alive, and mOS will be 14.2 months or less, which is similar to outcomes from previously reported trials where patients received the same chemotherapy treatment1. An analysis of all the first-line patients, including 3 experimental safety lead-in patients, shows similar results as the randomized first-line patients. The next survival analysis is planned in first half of 2021.
In June, it was reported that ONCOS-102 treatment induces broad and powerful immune activation in MPM, far beyond what is achieved with SoC alone. Importantly, this immune activation is associated with better survival outcomes at the 18-month analysis, indicating that the immunological activity of ONCOS-102 drives the observed clinical benefit.
The powerful immune activation generated by ONCOS-102 builds a strong rationale for combining ONCOS-102 with a checkpoint inhibitor in MPM. This combination could provide further clinical benefits in this indication. Targovax and Merck (known as MSD outside of the USA) are currently reviewing next steps for combining ONCOS-102 and pembrolizumab (Keytruda) in MPM. Recently, the U.S. Food and Drug Administration (FDA) approved the combination of ipilimumab and nivolumab (Yervoy and Opdivo) for the first-line treatment of MPM based on mOS of 18.1 months (Baas 2020), and this is expected to serve as a benchmark for further approvals.
Magnus Jäderberg, Chief Medical Officer of Targovax, said: "We are very pleased that overall survival in first-line patients, is tracking well in the ONCOS-102 treated group. We have already established in the current study that ONCOS-102 drives favorable remodeling of the tumor microenvironment, and we are now starting to see this immune activation translating into the encouraging improved survival outcomes in these 18-month results. This is exactly what we had hoped to see and prepares the way for combining ONCOS-102 with checkpoint inhibition. The immune data suggest to us that survival outcomes in combination with Keytruda may be further improved from the results reported today."
The first results from the trial were announced in January 2020 (see press release here), while immunological data and 12-month survival rate were reported in June 2020 (see press release here) and presented at the SITC annual meeting in November 2020 (see poster here).
1Vogelzang 2003, Ceresoli 2006, Zalcman 2015, Tsao 2019, Scagliotti 2019, Baas 2020 SITC 2020 poster
For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Andreas Tinglum - Corporate Communications (Norway)
Phone: +47 9300 1773
Kim Sutton Golodetz - LHA Investor Relations (US)
Phone: +1 212-838-3777
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