ORYX, a translational medicine company focused on oncolytic virotherapy and cancer vaccines, has announced positive findings from 16 patients treated with the oncolytic virus, ParvOryx, in combination with Avastin (bevacizumab) and with immune checkpoint inhibitors Keytruda or Opdivo under compassionate use programs. These promising results have encouraged ORYX to prepare a controlled clinical study, which will be discussed with regulatory authorities.
Seven patients suffering from glioblastoma multiforme (GBM) who had experienced a second relapse following treatment with ParvOryx in a completed phase I/IIa study were treated with ParvOryx plus Avastin following surgery. In the seven ParvOryx/Avastin-treated patients, median overall survival (mOS) was prolonged to 25.9 months compared to the ParvOryx monotherapy study mOS (15.9 months).
Additionally, nine GBM patients with either primary, diffuse primary, single recurrent or double recurrent GBM were treated with ParvOryx in combination with an immune checkpoint inhibitor alone or in combination with Avastin and an immune checkpoint inhibitor without prior surgery. All nine patients responded with objective tumour regression already after 6-8 weeks. The tumour load was reduced by 45-96% as measured by RANO (Response Assessment in Neuro-Oncology) criteria. Follow-up is ongoing.
Two patients relapsed (26 and 47 weeks) after virotherapy, while receiving constant treatment with Avastin and an immune checkpoint inhibitor. Treatment with ParvOryx together with the resumption of combination therapy with Avastin(R) and the checkpoint inhibitor led to rapid regression of the tumor mass and disease control.
Dr. Michael Dahm, ORYX's chief medical officer, said: "Although these data are preliminary and uncontrolled, they are highly encouraging. We look forward to evaluating ParvOryx in combination with Avastin or with Avastin(R) plus an immune checkpoint inhibitor in a controlled clinical trial setting."
Oryx announ, oncolytic virus parvoryx, immuno-oncology drugs
2.jpg)
