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Two Canadian Clinical Trials Show Poop Pills Could Help Patients Respond to Immunotherapy for Multiple Types of Cancer

Clinical trials in Ontario and Quebec have shown that fecal microbiota transplants (FMT) can reduce drug toxicity for patients treating certain cancers, as well as improving a patient's response to immunotherapy.
Clinical trials in Ontario and Quebec have shown that fecal microbiota transplants (FMT) can reduce drug toxicity for patients treating certain cancers, as well as improving a patient's response to immunotherapy.

Findings from two Canadian clinical trials reveal that fecal microbiota transplants (FMT) can dramatically improve cancer treatment.

According to Nature Medicine journal, the first study revealed that toxic side effects of drugs to treat kidney cancer could be eliminated with FMT, while the second study suggests FMT is effective in improving the response to immunotherapy in patients with lung cancer and melanoma.

“Standard treatment for advanced kidney cancer often includes an immunotherapy drug that helps the patient’s immune system tackle cancer cells,” said Saman Maleki, PhD, Scientist at London Health Sciences Centre Research Institute (LHSCRI).

These findings are a giant step in using FMT capsules, which were developed at Lawson Research Institute (Lawson) of St. Joseph’s Health Care London and used in clinical trials at LHSCRI, and Centre de recherche du Centre hospitalier de l’Universite de Montreal (CRCHUM) for safe and effective cancer treatment.

Scientists at LHSCRI and Lawson conducted Phase I in the clinical trial to determine if FMT would be safe for patients when combined with an immunotherapy drug while treating kidney cancer.

The trial involved 20 patients at the Verspeeten Family Cancer Centre at London Health Sciences Centre (LHSC).

“Unfortunately, the [standard] treatment frequently leads to colitis and diarrhea, sometimes so severe that a patient must stop life-sustaining treatment early,” added Maleki.

“If we can reduce toxic side effects and help patients complete their treatment, that will be a gamechanger.”

A separate Phase II study was completed by researchers at CRCHUM in collaboration with Lawson and LHSCRI. This study focused on lung and skin cancer.

Phase II studies found that 80 per cent of patients with lung cancer responded to immunotherapy after FMT, compared to only 39-45 per cent typically benefitting from immunotherapy alone.

Similarly, 75 per cent of patients with melanoma who received FMT experienced a positive response to treatment, compared to only 50-58 per cent response in patients who receive immunotherapy alone.

Twenty patients participated in Phase II trials for lung cancer, and 20 patients participated in the skin cancer clinical trial.

“Our clinical trial demonstrated that FMT could improve the efficacy of immunotherapy in patients with lung cancer and melanoma,” said Dr. Arielle Elkrief, co-principal investigator and Physician Scientist, CRCHUM.

According to Dr. Elkrief, these results uncovered one possible mechanism of action of fecal transplantation, through the elimination of harmful bacteria following the transplant.

“Our results open up a novel avenue for personalized microbiome therapies, and fecal transplant is now being tests as part of the large pan-Canadian Canbiome2 randomized controlled trial,” added Dr. Elkrief.

Both studies used advanced, world-leading FMT capsules, also known as LND101, produced by Lawson in London, Ontario.

This research reinforces London’s place as a global leader in FMT innovation and treatment.

According to CHUM, the capsules are processed from healthy donor stools and ingested to help restore a patient’s healthy gut microbiome – genetic material of the entire collection of microbes (bacteria, viruses, etc.) living in or on your body - and treat different types of cancer.

“Fecal microbiota transplantation in melanoma and lung cancer opens an entirely new therapeutic avenue, made possible by the exceptional commitment of our patients and the teamwork,” added Dr. Rahima Jamal, Director of the Unit for Innovative Therapies (UIT) at CRCHUM.

“At the UIT, we had the privilege of transplanting laboratory discoveries into early phase clinical trials and witnessing their concrete impact on people living with cancer.”

According to Dr. Michael Silverman, Scientist at Lawson and Head of St. Joseph’s Infectious Diseases Program, although FMT can reduce drug toxicity and improve patient’s quality of life, it has never been done in treatment kidney cancer before this.

Dr. Silverman explains that none of this would be possible without this close collaboration to advance vital research.

Studies show FMT can safely augment treatment for people with melanoma. FMT is also being studied in people with pancreatic cancer and triple-negative breast cancer. It is already a well-established treatment for serious gut infections such as C. difficile, which can cause severe diarrhea.

Dr. Ricardo Fernandes, Scientist at LHSCRI and Medical Oncologist at LHSC explains that it is the hope of all those in collaboration that their research will one day help people with cancer live longer while reducing harmful side effects of treatment.

“We are world leaders in FMT research, and we’re excited about its potential,” added Dr. Fernandes.

The Canadian Cancer Society funded the lung and melanoma study. The kidney cancer clinical trial was funded with support from Ontario Institute of Cancer Research, Canadian Institutes of Health Research, AMOSO, Western University’s Division of Medical Oncology, donors to London Health Sciences Foundation and St. Joseph’s Health Care Foundation, the Hesch Foundation and Weston Family Foundation.

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