In a phase 2b trial, the cancer vaccine, MVX-ONCO-1, demonstrated a prolonged overall survival and tolerable safety profile among patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

These data were presented by Nicolas Mach, MD, Geneva University Hospital, Geneva, Switzerland, on Saturday, October 21, 2023, at the European Society for Medical Oncology Annual Congress (ESMO) in Madrid, Spain.

The MVX-ONCO-1 vaccine combines irradiated autologous tumor cells and devices with allogeneic cells to produce a potent adjuvant granulocyte macrophage colony-stimulating factor (GM-CSF) and a personalized, subcutaneous cancer vaccine. Previously, data from a phase 1 study showed evidence of immune education among patients.

In this phase 2b trial, 16 patients with recurrent/metastatic HNSCC who had progressed on ≥1 line of systemic therapy were enrolled. Patients received 6 treatments over 8 weeks of MVX-ONCO-1. The primary end point was overall survival (OS) at 26 weeks. An unplanned review of the first 10 patients found that 7 met the 26-week overall survival end point. The sample size was then reduced from 36 to 21. Secondary end points included response and safety.

The median overall survival is 11.4 months, with the 12-month and 18-month OS at 49.2% and 31.6% respectively. The objective response rate at 26 weeks is 12.5%, with a disease control rate of 75% at 6 weeks. There were no systemic adverse events related to the treatment. Study authors also noted a “strong correlation between OS and Delayed Type Hypersensitivity (DTH).” At 12-months, all DTH-positive patients were alive, compared with only 1 DTH-negative patient.

In conclusion, Mach et al stated, “Clinically meaningful prolonged survival, [partial response] and [complete response] were observed in [immunotherapy]-refractory” patients with recurrent/metastatic head and neck squamous cell carcinoma.” Adding, “MVX-ONCO-1 is the first cancer vaccine associated with prolonged survival in advanced chemo[therapy]/[immunotherapy] refractory disease in monotherapy without maintenance.”

Source:

Mach N, Fernandez E, Vernet R, et al. SAKK 11/16, a phase IIa trial evaluating overall survival (OS) for recurrent/metastatic Head & neck squamous cell carcinoma (RMHNSCC) patients (pts) progressing after ≥ 1 line of systemic therapy, treated with MVX-ONCO-1, a novel, first in class cell encapsulation-based immunotherapy. Presented at ESMO 2023; October 20-23, 203; Madrid, Spain. Abstract LBA46