Gradalis Inc. presented initial data from its phase II trial for Ewing’s sarcoma at the 2018 Annual Meeting of Children’s Oncology Group.
This is a two-part open-label, non-randomized, single-arm phase PP study in patients with recurrent or refractory Ewing’s Sarcoma. Part 2 of the study was established in order to assess safety and efficacy of Temozolomide / Irinotecan in combination with Vigil. All patients included in the study signed informed consent for tissue procurement treatment on the study according to the requirements of each individual institution.
As of Oct. 5, eight patients were enrolled in Part 2 of the trial, and five patients are still alive. Two patients experienced RECIST partial response and retrospectively confirmed histological complete response. Four patients had durable stable disease as best response for ≥6 months.
All eight patients had histologically confirmed Ewing’s Sarcoma. The mean age was 24 years (range: 12-46 years). All patients were heavily pretreated and failed treatment with Temozolomide and Irinotecan previously, with a mean of 5 lines of systemic treatments prior to study enrollment.
Historical progression-free survival for patients in second relapse (or greater) Ewing’s Sarcoma is 3 months or less. The median progression-free survival of the patients enrolled was 8.2 months.
The combination of Vigil, Irinotecan and Temozolomide in third-line or greater Ewing’s Sarcoma demonstrated favorable safety profile with limited treatment-related toxicities.
Phase II data demonstrates similar results from phase I trial. Previously published data of patients in second relapse (or greater) Ewing’s Sarcoma enrolled and treated with Vigil monotherapy on a phase I study revealed clinical benefit with a median survival of 2 years. While the median OS of patients in the phase II study, treated with the combination of Vigil, Irinotecan, and Temozolomide has not been reached, favorable event-free survival has been observed.
Vigil is a proprietary, investigational cellular immunotherapy technology that combines genetic engineering with the science of immuno-oncology. Vigil is intended to stimulate and enhance the body’s natural mechanism for recognizing and killing cancer cells. It utilizes the patient’s own cancer cells to create a fully personalized cancer immunotherapy.
By utilizing the patient’s own tumor as the antigen source, Vigil is designed to elicit an immune response that is specifically targeted and broadly relevant to each patient’s unique tumor antigens. Vigil is being studied in Ewing’s sarcoma, in gynecological cancer and advanced women’s cancer in combination with PD-L1 inhibitors, and ovarian cancer as a single agent.
