Targovax has completed patient enrollment in the phase I trial with ONCOS-102 in combination with Keytruda in patients with advanced anti-PD1 checkpoint inhibitor (CPI) refractory melanoma.
In this trial, ONCOS-102 immune activation is being tested in patients with advanced, unresectable melanoma who have had disease progression on treatment with anti-PD1 CPI. This is a particularly challenging patient population, with few treatment alternatives available. In July 2019, Targovax reported encouraging results from part 1 of the trial.
Part 2 of this trial is testing an extended ONCOS-102 dosing regimen with up to twelve injections compared to three injections in part 1. The enrollment of 12 patients into part 2 of the trial has now been completed. The last patients will complete their six months treatment and data on a total of 21 patients are expected in the second half of 2020.
ONCOS-102 and Keytruda combination treatment
The primary and secondary endpoints of the trial are to assess safety, immune activation and clinical responses of ONCOS-102 and Keytruda combination treatment. The main scientific aim is to test the hypothesis that ONCOS-102 can immune activate anti-PD1 refractory patients to respond to re-challenge with an anti-PD1 CPI.
“We are very pleased to have completed enrollment of our melanoma trial. ONCOS-102 is currently one of the most clinically advanced oncolytic viruses in this difficult to treat cancer, and therefore a high priority for us. With this trial also being a proof of concept trial, clinical and immune data from this study will not just indicate whether ONCOS-102 in combination with CPIs can help patients with hard to treat melanoma but potentially also other tumor indications. Supportive data could open the path for a registrational trial,” says Magnus Jäderberg, CMO of Targovax.
Photo of Magnus Jäderberg: Targovax