A Victoria researcher leading an immunotherapy clinical trial that’s saving the lives of late-stage leukemia and lymphoma patients says the province’s plan to start treating patients with a nearly identical commercial product is positive news.
“When we look at it from the patient’s perspective, the more options the better,” said Victoria-based Dr. Brad Nelson, who co-leads B.C. Cancer’s Immunotherapy Program.
Chimeric antigen receptor T-cell therapy — commonly referred to as CAR-T — treats lymphoma and some types of leukemia by withdrawing white blood cells from the patient, isolating the cancer‑fighting T cells, and genetically engineering them into an enhanced “product” to target and destroy cancer cells once it’s delivered intravenously back to the patient.
Nelson is leading a group of Canadian researchers, headquartered in Victoria, Vancouver and Ottawa, who have developed and are testing a CAR-T cell product similar to the one the province will source from the United States to treat 25 patients at one of two hospitals in Vancouver.
As the Victoria researchers close in on completing clinical trials this year, Nelson said there’s “room in the world for both products.”
“Our CAR-T product has both similarities and differences compared to the commercial products,” said Nelson. “So it’s good for cancer patients in B.C. to have both options now.”
Currently, B.C. patients eligible for pricey but potentially life-saving CAR-T cell therapy are sent to Ontario, with a small number going to Quebec and Seattle — where the frozen U.S. product is administered intravenously to the patient.
Saskatchewan, Manitoba and Nova Scotia are also treating patients with CAR T-cell therapy in their own provinces.
On top of the $500,000 for a pharmaceutical company to make the blood product from a patient’s cells, the province has covered out-of-province or out-of-country travel and accommodations for B.C. residents.
Now, for the first time, the province plans to provide the immunotherapy treatment at Vancouver General Hospital or B.C. Children’s Hospital starting this month for 20 adults and five children with lymphoma and some forms of leukemia who haven’t had success with other treatments.
Health Minister Adrian Dix says $14.3 million is in this year’s budget for the treatment program.
Patients must be otherwise medically fit and have an eligible blood cancer — large B-cell lymphoma, B-cell acute lymphoblastic leukemia and mantle cell lymphoma — that has worsened despite being addressed with at least two other different treatment types.
Because not all patients are fit enough to withstand CAR-T cell therapy, which carries significant toxicities and even risk of death from complications, medical fitness including organ function, other medical conditions and frailty will be assessed initially by the patient’s oncologist/ hematologist and then by the CAR T-cell therapy physician.
The Health Ministry said the amount budgeted includes hiring about 13 full-time equivalent positions, many of which are already filled. It said some money will be saved by not sending patients out of B.C. for care.
B.C. Cancer will use a commercial CAR-T cell product from the U.S., pending the outcome of the B.C.-made product, which is still in clinical trials and in need of Health Canada market authorization. Once that authorization happens, the province will assess transitioning to the B.C. product, Dix said.
Pharmaceutical companies Novartis and Kite/Gilead have already developed Health Canada approved and funded CAR-T cell therapies.
Nelson leads the Conconi Family Immunotherapy Lab in Victoria, the first in Canada to produce CAR-T cells to treat patients when it was established in 2016.
Its first- and second-phase clinical trials launched in 2019 and involved B.C. Cancer and Ottawa Hospital, with the CAR-T cells manufactured in Victoria. Of the first 30 patients treated, 13 saw their cancers disappear to the point of being undetectable.
“Confidence is high,” said Nelson. “The first 30 patients showed that in a rigorous way and with the additional patients we’re continuing to feel confident that this product is both safe and efficacious.”
Participant Noel Schacter, 79, who lives in James Bay, is in remission more than three years after other treatments for his aggressive non-Hodgkin’s lymphoma failed. Before he was accepted into the clinical trial in 2020, he looked into CAR-T cell therapy in Seattle, but the cost was more than $1 million.
The 100-person B.C. trial has treated 78 patients.
Nelson notes the CAR-T cell products produced in Victoria are similar but not identical to the commercial products from pharmaceutical companies.
“We think there’s features of our products which are better,” said Nelson.
Unlike commercial products which are shipped frozen, the Victoria clinical trial takes freshly drawn T-cells from a patient in a Vancouver hospital, genetically engineers them in Victoria, and delivers the enhanced T-cells in an IV bag back to the patient in Vancouver.
“We think that might offer advantages,” said Nelson. “We’ve got to get the product back to the patient within a couple of days. We’ve worked out all the logistics to do that very efficiently.”
The academic researchers are working on how to scale up production for use across Canada.
The clinical trial also differs in that patients donate 15 different blood samples so researchers can probe why the re-engineered T-cells fail in some patients.
“When you’re working with commercial products, you don’t have that capability,” said Nelson. “What we’re doing is research and it’s not only providing care for patients today, but we’re really going be learn how to make better CAR-T cells for patients tomorrow.
“That’s why it’s important to have both the commercial products for patients but also these research options.”
The clinical trial is funded mostly by charitable donations and grants and it’s been argued that more government funding is needed to speed up and expand life-saving clinical trials and to re-establish B.C. as a leader in cancer research and treatment. “I think government understands that and we are having productive discussions with them,” said Nelson.
Nelson is also the founding director of the Deeley Research Centre, which is devising strategies for CAR-T cells to treat solid tumours, specifically ovarian and pancreatic cancer, among the two most difficult to treat in part because they have tougher defence mechanisms that block T-cells.
The pre-clinical studies in ovarian cancer have yet to be tested on humans, but Nelson said researchers are getting “very exciting results” in the lab.
“We’re charging ahead with this and hoping to open a Phase 1 clinical trial of that within two to three years.”
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