Targovax’s ONCOS-102 mesothelioma 12-month data demonstrate broad immune activation linked to clinical benefit and the company announces a new collaboration with Merck.
Targovax has released 12-month efficacy and immunological data from the randomized phase I/II trial of ONCOS-102 in combination with standard of care chemotherapy in malignant pleural mesothelioma (MPM).
Clinical development of ONCOS-102
The trial is an open label, exploratory phase I/II trial adding ONCOS-102 to standard of care (SoC) chemotherapy (pemetrexed/cisplatin) in first and second (and later) line MPM to assess safety, immune activation and clinical efficacy vs SoC only. In total, 31 patients have been treated in the trial, with 20 patients in the experimental group receiving the ONCOS-102 and SoC combination, and 11 patients in a control group receiving SoC only. The 31 patients have now completed the 12-month follow-up. The first set of data was reported in January 2020, with an update in May 2020.
“We are very pleased to see the encouraging first line PFS data holding up in the 12-month analysis, with early signs of positive survival outcomes. We are particularly excited to observe a broad and profound immune activation in the ONCOS-102 treated patients, which confirms the proposed mode of action. ONCOS-102 treatment clearly drives a favorable remodeling of the tumor microenvironment, and this remodeling is linked to better clinical outcomes. This immune activated tumor micro-environment provides the key scientific rationale and an ideal backdrop for combination treatment with a checkpoint inhibitor. These data set us up perfectly to move forward with a trial combining ONCOS-102 and a checkpoint inhibitor, which we believe will release the full potential of immunotherapy in this hard-to-treat patient population,” says Magnus Jäderberg, Chief Medical Officer of Targovax.
Targovax’s future clinical development of ONCOS-102 will focus on first line mesothelioma with the triple combination of a checkpoint inhibitor, ONCOS-102 and SoC, the company states.
Collaboration agreement with Merck
Targovax has entered into a collaborative agreement with Merck & Co with the intent to initiate a randomized phase II trial to evaluate the combination of ONCOS-102, Keytruda (pembrolizumab), MSD’s anti-PD-1 therapy, and standard of care (SoC) chemotherapy in malignant pleural mesothelioma.
Following the new findings reported above, Targovax and MSD have agreed to initiate a collaboration trial evaluating the combination of ONCOS-102, KEYTRUDA and SoC in first line mesothelioma patients. The trial will be a randomized phase II of up to 100 patients comparing this investigational triple combination against Keytruda and SoC. There is strong interest to participate in the trial among key opinion leaders and investigators, and multiple centers in both the USA and EU will be participating. The aim is to start enrolling patients into the trial within twelve months.
“We believe the clinical immune activation data we have seen so far provide a strong scientific rationale for adding anti-PD1 checkpoint blockade to the ONCOS-102 and chemotherapy combination in mesothelioma. Therefore, we are delighted that MSD has agreed to support us in exploring this hypothesis by providing KEYTRUDA supply for our next trial. KEYTRUDA is the market-leading checkpoint inhibitor and thus our preferred choice of partner. We are hopeful that the combination of ONCOS-102, pembrolizumab and chemotherapy will lead to improved outcomes for patients with this challenging disease who currently have few treatment alternatives,” says Øystein Soug, CEO of Targovax.
Photo of Magnus Jäderberg, CMO, Targovax