Immunotherapy for pancreatic cancer improves survival without added adverse effects

Adding a new immunotherapy to chemotherapy improved survival in patients with advanced pancreatic cancer—particularly in those with metastatic disease—compared with patients given chemotherapy alone. Notably, patients who received the combination treatment experienced no additional toxicity, according to a proof-of-concept study published September 6, 2016 in the British Journal of Cancer.

The new immunotherapy is IMM-101, a suspension of heat-killed Mycobacterium obuense. For this Phase II study, researchers administered IMM-101 in combination with gemcitabine, the first-line chemotherapy for advanced pancreatic cancer.

“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 lead author Angus Dalgleish, MD, Professor of Oncology at St. George’s University of London, in London, UK.

A previous Phase I clinical trial showed IMM-101, which is given by injection, to be safe and well tolerated in patients with melanoma.

“In my melanoma patients in particular, patients have shown greatly increased survival rates and enjoy a much better quality of life,” Dr. Dalgleish said. “In some patients I’ve actually seen the cancer disappearing altogether.”

For this Phase II investigation, researchers from 20 centers in five countries recruited 110 patients with advanced pancreatic ductal adenocarcinoma (with or without metastasis), and randomly assigned them to gemcitabine plus IMM-101 therapy (75 patients) or gemcitabine alone (35 patients). Patients were treated for a maximum of 12 cycles.

At the end of treatment, the patients who received immunotherapy plus chemotherapy had the same rate of adverse events as the patients on chemotherapy alone. Median overall survival was also statistically similar in both groups (6.7 months for the IMM-101 group vs. 5.6 months for the gemcitabine-only group). However, progression-free survival was greater in the immunotherapy group (4.1 months) than in the chemotherapy group (2.4 months), the researchers found.

In a pre-defined subgroup of metastatic patients, those in the immunotherapy therapy group had significantly greater overall survival (7.0 months) than those in the chemotherapy-only group (4.4 months).

“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,” Dr. Dalgleish said. “I believe IMM-101 could revolutionize the way this cancer is treated globally.”

To that end, the researchers are now initiating a follow-up Phase I/IIa trial to evaluate the safety, tolerability, and activity of IMM-101 in combination with different chemotherapy regimens in patients with pancreatic cancer.

Immodulon Therapeutics Ltd. partially funded this study.