Date: 2016-09-16
Type of information: Publication of results in a medical journal
phase: 2
Announcement: publication of results in the British Journal of Cancer
Company: Immodulon Therapeutics (UK)
Product: IMM-101 (heat killed whole cell mycobacterium obuense)
Action
mechanism: immunotherapy product. IMM-101 is a suspension of heat-killed whole cell Mycobacterium obuense in borate-buffered saline which is administered intradermally. IMM-101 works by harnessing the power of the immune system to recognise, respond to and control cancer. By tackling cancer cells on multiple pathways, IMM-101 helps the body to improve both innate and adaptive immunity making it even more effective. It can be used alongside other treatments for cancer (such as radiotherapy, chemotherapy and checkpoint inhibitors). Orphan status has been granted by the FDA and the EMA for IMM-101 for the treatment of advanced pancreatic cancer.
Disease: advanced pancreatic cancer
Therapeutic area: Cancer - Oncology
Country: Cyprus, Ireland, Italy, Spain, UK
Trial
details: 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. (NCT01303172)
Latest
news: * On September 16, 2016, Immodulon announced published results for a Phase II proof-of-concept study into the treatment of advanced pancreatic cancer. The results have been published in the British Journal of Cancer, in partnership with St George’s Hospital, London, and show a 59% increase in survival time for patients with metastatic disease receiving Immodulon’s flagship immunotherapy treatment, IMM-101. 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. ( ASCO Poster Presentation # 3051)
The study was designed to provide indicative rather than definitive efficacy results, but exceeded expectations in the patients treated with both IMM-101 and gemcitabine (chemotherapy), over those receiving gemcitabine alone:
• Patients lived significantly longer on the combination of IMM-101 plus gemcitabine. The overall medial survival in a pre-defined subgroup of patients with metastatic disease (N=64; 84% of the intention to treat population) was increased by 59% (2.6 months) which is extremely promising and warrants further evaluation in an adequately powered confirmatory study.
• Some patients lived considerably longer (years) than expected, as shown by the “long tail” on the survival curve. This is particularly notable because metastatic pancreatic cancer is one of the deadliest forms of cancer, and life expectancy following diagnosis is very short, with median survival about 6 to 11 months.
• Progression-free survival was significantly improved for patients with metastatic disease receiving IMM-101 and gemcitabine as compared to gemcitabine alone.
• Unlike other cancer treatments, IMM-101 has very limited side effects such as injection site reactions and flu-like symptoms.
Charles Akle, Chairman of Immodulon said that the next phase of testing is imminent, after which, the company hopes to be able to bring IMM-101 to market for the widest possible number of patients.
* On May 14, 2015, Immodulon Therapeutics 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. 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.
