VAXIMM’s VXM01 shows encouraging results in Phase I/II study with brain cancer patients

The multicenter, open-label Phase I/II trial is designed to evaluate the safety and tolerability of VXM01 in combination with the PD-L1 inhibitor avelumab in 30 patients with recurrent glioblastoma at multiple clinical sites in Europe. Secondary endpoints include objective response rate (ORR), clinical response using immune-response assessment in neuro-oncology (iRANO) criteria and immunological assays. Nine patients treated with VXM01 and avelumab in 2 dose groups had completed the safety run-in phase. The trial is part of a collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc.

No treatment-related toxicities were observed in the 9 patients treated. Three partial responses according to iRANO criteria with tumor reductions of 58, 81 and 95% to baseline were reported. Two of these patients have been progression free for more than 6 months. Furthermore, significant VEGFR2-specific T-cell responses were measured in several patients, and pre-existing intra-tumoral T-cells were positively associated with the effectiveness of the immunotherapy combination.

Highly encouraging results
Prof. Wolfgang Wick, MD, Chairman, Department of Neurology, Heidelberg University Hospital, Heidelberg, Germany, and principal investigator of the study, commented: “We are excited to see these highly encouraging initial results, including three partial responses, from this combination trial. The data seen so far support the scientific rationale that PD-L1 checkpoint inhibition may enhance the activity of the VXM01 vaccine. There is an urgent need for effective treatments for this deadly form of brain cancer.”

The safety run-in results from the Phase I/II study are being presented as an oral presentation at the 2020 American Society of Clinical Oncology (ASCO) Virtual Meeting being held May 29-31, 2020.