New Data from IMAGE 1 Show Improved Survival in Metastatic Pancreatic Cancer in Patients Receiving IMM-101

LONDON, May 14, 2015 /PRNewswire/ -- Immodulon Therapeutics today announced updated results of long-term survival from IMAGE 1, a randomized, controlled, open-label, Phase II clinical trial comparing the combination of IMM-101 and gemcitabine (IMM-101 treated) versus gemcitabine alone (control) as first-line treatment for advanced pancreatic cancer. The data will be presented at the American Society of Clinical Oncology (ASCO) annual meeting, May 29 to June 2, in Chicago, IL.

The newly released data from IMAGE 1 found that treatment with IMM-101, a bacterially derived systemic immunomodulator administered intradermally in combination with gemcitabine, was, in patients with metastatic disease, associated with improvements in the probability of survival at 12 months to 24% compared to 11.5% in the gemcitabine alone group.  This difference was amplified at 18 months to 18.3% for IMM-101-treated patients compared to 2.3% in the control group and at 24 months the corresponding survival probabilities were 11% and 0%. This is in addition to the previously reported consistent and significant improvements in overall survival (OS) and progression free survival (PFS) in patients with metastatic pancreatic cancer.

"This is the first randomized, controlled study to assess the efficacy of combining a systemic immunomodulator with chemotherapy as first-line treatment in advanced pancreatic cancer and draws attention to the potential of such combinations as a way of improving longer term survival in this deadly disease, without precipitating toxicities," said Professor Angus Dalgleish, M.D., Foundation Chair of Oncology, St. George's University of London and Chief Investigator of IMAGE 1.

Treatment with IMM-101 led to the greatest survival benefit in patients with metastatic disease. The times corresponding to 25% probability of survival are 11.6 months for the IMM-101-treated patients compared to 7.2 months (p=0.009) for the control group, which represents an extension of 4.3 months of life.

"It is the separation in the tail of the Kaplan-Meier curve that is of interest with immunotherapy. These more durable responses seen in a proportion of patients are consistent with findings with immunotherapy for other cancers but were not predicted in advanced pancreatic cancer. We are now planning the further development of IMM-101 in combination with chemotherapy as a first-line treatment for metastatic pancreatic cancer and, in parallel, we intend to evaluate IMM-101 combinations in other tumor types," said Dr. Kevin Bilyard, Chief Executive Officer, Immodulon.

Further details of the study will be available at the ASCO Poster Presentation # 3051 scheduled for Saturday, May 30 during the Immunotherapy Session from 8:00 am – 11:30 am (CST).

About IMAGE-1
In the IMAGE 1 (Immune Modulation And Gemcitabine Evaluation 1) study, patients with advanced pancreatic cancer and a WHO score of 0-2 were assigned randomly in a 2:1 ratio to receive IMM‑101 (intradermal injection of 0.1 mL, 10 mg/mL) plus gemcitabine (1000 mg/m² for 3 consecutive weeks out of 4) or gemcitabine  alone for a 12-cycle maximum. The efficacy endpoint of primary interest was overall survival (OS); progression free survival (PFS), safety and tolerability were also assessed.  

IMM-101 was associated with clinically meaningful increases in OS and PFS, with no overall increase in frequency of adverse events. First-line IMM-101 with adjunctive chemotherapy produced substantial survival benefits in patients with metastatic disease.

About Pancreatic Cancer
Pancreatic cancer is the fourth leading cause of cancer-related death in Europe and the USA. Metastatic pancreatic cancer has a dismal 5‑year survival rate of 1%. Due to the poor prognosis for advanced pancreatic patients any survival gains are more significant in this patient population.

About IMM‑101
IMM‑101 is a suspension of heat-killed whole cell Mycobacterium obuense (NCTC13365) in borate-buffered saline which is administered intradermally. IMM‑101 has completed Phase 2 clinical development in advanced pancreatic cancer and as such is not yet a licensed or approved product. 

IMM-101 is a systemic immunomodulator which has effects on innate and adaptive immune responses and which may have application across a variety of tumor types.

About Immodulon
Immodulon Therapeutics Ltd is a privately owned, UK-based biopharmaceutical company focused on developing systemic immunomodulators as potential treatments for a range of cancers.

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SOURCE Immodulon Therapeutics