In IMAGE-1, a phase II proof-of-concept study recruiting 110 patients with locally advanced or metastatic pancreatic cancer, patients were randomized to receive IMM‑101 + gemcitabine or gemcitabine alone. This study was designed to provide indicative rather than definitive efficacy results, but exceeded expectations by providing promising overall survival results and durable responses in all prospectively defined populations as well as a favourable safety profile. The overall intention to treat (ITT) analysis showed a numerical benefit for IMM‑101 + gemcitabine versus gemcitabine alone, while the overall per-protocol (PP) analysis and both ITT and PP analyses in metastatic patients were clinically and statistically significant.
The Figure shows the Kaplan Meier (KM) survival curves for the ITT population with metastatic disease, where an increase in median survival of 2.6 months corresponds to a 59% increase in survival for patients receiving IMM‑101 + gemcitabine compared to gemcitabine alone. Equally importantly, the continued separation of the KM curves to 24 months and the survival outcomes at 12, 18 and 24 months indicate a durable response for some patients with this devastating disease. Safety analyses indicated no apparent additional burden of side-effects in adding IMM‑101 to gemcitabine and quality of life data were encouraging.
Results were presented at a leading global cancer conference in US (ASCO-GI [American Society of Clinical Oncology Gastro-intestinal Cancers Symposium]) in January 2015, updated survival data were presented at the main ASCO meeting in May 2015 and initial quality-of-life data presented at ESMO-GI in July 2015. The results from the Phase II pancreatic cancer study have also been published (Dalgleish et al, 2016). More recent analyses on the Phase II data have suggested a predictive baseline marker for treatment effect with IMM‑101, which will be used for stratification at baseline in the planned pivotal registration study.