Positive results from phase 1 follow up study supports current phase 2 clinical trial of IMM-101 in combination with checkpoint inhibitor therapy
Immodulon, the immuno-oncology company, today announces that long-term survival data from its phase 1 study in 18 patients with advance melanoma treated with IMM-101 has been presented at The Society for Melanoma Research 2019 Congress, in Salt Lake City, Utah, USA, 20-23 November 2019.
The poster, entitled ‘Long-Term Survival of Patients with Stage III/IV Melanoma Receiving IMM-101’ was authored by Dr Alberto Fusi, of St George’s University Hospital NHS Foundation Trust and Professor Angus Dalgleish, of St George’s University of London. The poster presented by Dr Fusi reports the long-term survival data of patients with advanced melanoma enrolled in Immodulon’s phase 1 placebo controlled, dose escalation study of IMM-101. Following the phase 1 safety study, treatment with IMM-101 continued, initially on a compassionate use programme followed by a long term follow up study that was closed in December 2018.
Dr Alberto Fusi, the principle investigator of the follow-up study, said: “Following the phase 1 dose escalation study of 18 patients with unresectable stage III and IV melanoma, 13 patients were treated on a named patient programme with 10 patients joining the long-term follow-up study thereafter. We have been able to record nine surviving patients at five years and eight surviving patients at eight years. This is encouraging data which forms a solid basis for and reinforces the hypothesis behind our ongoing phase 2 study of IMM-101 in combination with checkpoint inhibitor therapy in advanced melanoma. We hope that results for the patients in the current trial will be further improved from what we have been able to demonstrate here.”
The Society for Melanoma Research 2019 Congress is a global congress that unites melanoma clinicians and researchers to focus on multidisciplinary management of melanoma and other skin cancers. It provides key insight into the practical advantages of multidisciplinary care of patients with cutaneous malignancies. This is the leading meeting for cutting edge data in melanoma with over 1,000 healthcare professionals in attendance including researchers, medical oncologists, dermatologists and surgical oncologists.
Immodulon’s current advanced melanoma trial, IMM-101-015 (NCT03711188) is an ongoing open label phase 2 study that will enrol up to 26 patients with unresectable stage III, or stage IV melanoma who are either treatment-naive (18 patients) or whose disease has progressed during or after treatment with PD-1 blockade (8 patients). The primary objective of the trial is to assess the safety and efficacy of the combination of IMM-101 with nivolumab. Secondary objectives include overall survival and progression-free survival at 18 months.