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.
Kaplan Meier (KM) survival curves for the ITT population with metastatic disease.
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.
EudraCT Noumber: 2010-022757-42
ClinicalTrials.gov Identifier: NCT01303172