Combining the investigational immunotherapy agent IMM-101 with chemotherapy significantly improved the survival of patients with advanced pancreatic cancer, compared to those who received chemotherapy alone, by “waking up the immune system,” investigators in a clinical trial reported.
The study, “Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer,” published in the British Journal of Cancer, showed that some patients lived several years longer than expected after receiving IMM-101 plus chemotherapy.
“The results from this study are remarkable and represent a significant breakthrough in the development of immunotherapy for the treatment of pancreatic cancer,” Charles Akle, chairman of Immodulon, owner of IMM-101, said in a press release. “The next phase of testing is imminent, after which, we hope to be able to bring IMM‑101 to market for patients.”
IMM-101 is a naturally occurring mycobacterium, called Mycobacterium obuense, that has been treated to be harmless to humans. It works by activating a number of cells of the immune system, including gamma delta T-cells, granulocytes, and antigen-presenting cells, making them highly active against tumor cells.
“In my experience of using IMM-101 to treat cancer patients, we see that using IMM-101 ‘wakes up’ the immune system without any added toxicity,” said Angus Dalgleish, professor of Oncology at St George’s, University of London. “In my melanoma patients in particular, patients have shown greatly increased survival rates and enjoy a much better quality of life. In some patients I’ve actually seen the cancer disappearing altogether.”
In this randomized, open-label, Phase 2 clinical trial (NCT01303172), researchers examined the safety and tolerability of IMM-101 plus Gemzar (gemcitabine) in patients in Europe with advanced pancreatic ductal carcinoma.
Metastatic pancreatic cancer is one of the most deadliest forms of cancer, with a median life expectancy after diagnosis of between six and 11 months. In these patients, chemotherapy is the standard of care, since the tumors cannot be surgically removed. Gemzar is currently the chemotherapeutic drug of choice for this type of cancer, and may be combined with other chemotherapeutic agents, but such treatment usually has a high toxicity and debilitating side effects.
In this trial, researchers found that the median overall survival increased by 59 percent (2.6 months) in patients in the IMM-101 group, compared to those in the chemotherapy only group. Importantly, the combination resulted in no added toxicity for patients.
“These are exciting results and support our hope that immunotherapy will in future become a generally accepted treatment for a wide range of cancers, improving both survival rates and quality of life,” said Harry Cotterell OBE, chair of trustees with the Institute for Cancer Vaccines and Immunotherapy.
Although IMM-101 is currently an experimental treatment, Dalgleish wants to see it in clinical use as soon as possible.
“I have seen first-hand that this is a hugely beneficial treatment for patients and I’d like to see it translated to every hospital in the country. I believe IMM-101 could revolutionise the way this cancer is treated globally,” he said.