The benefits of the new treatment, which uses pre-manufactured donor T cells, have been shown to last for at least 120 days.
More Australian lymphoma patients could access a new treatment as part of a phase 1b trial.
In January, the Royal Prince Alfred Hospital in Sydney delivered the first dose of the novel allogenic CAR T cell therapy azercabtagene zapreleucel (azer-cel) to an Australian patient with diffuse large B cell lymphoma.
The Phase 1b trial, sponsored by immuno-oncology company Imugene, is the first to pair lymphodepletion chemotherapy with interleukin-2 to improve the therapeutic benefits of azer-cel in patients with relapsed or refractory DLBCL, an aggressive form of non-Hodgkin’s lymphoma.
The approach, which is one of a handful of allogenic CAR T cell therapies being evaluated in the country, is described as “an off-the-shelf alternative to traditional autologous CAR T cell therapies” by Imugene.
The therapy involves the use of pre-manufactured donor T cells, with the company stating “azer-cel has the potential to significantly shorten treatment timelines and expand accessibility for patients with limited treatment options.”
Imugene managing director and CEO Leslie Chong told Haematology Republic that autologous CAR T cell therapies were a lengthy process that didn’t guarantee a response.
“Patients come in and sit for anywhere between 7-8 hours while undergoing a leukapheresis process, which removes T cells from the blood. The T cells are then taken to a specialised lab for 19 to 42 days for engineering. Roughly 20% of patients can’t take their own T cells back, and about 60-65% of patients of patients who do receive autologous CAR T cells either progress [with their disease] or the treatment fails.
“Our allogenic CAR T cell therapy is very different. When a patient comes in after experiencing autologous CAR T cell therapy failure, meaning their disease is progressing and their tumours start growing again, the doctor can schedule a time for them to get azer-cel on demand as they need it – along with a very low dose of IL-2 as a means of firing up the T cells and the azer-cel.”
The cost associated with manufacturing allogenic CAR T cells is expected to decrease with time, Ms Chong explained.
“I liken it to electric cars – the first few were quite expensive because the manufacturing uptick was huge. But now you can get one for a more reasonable price. I think allogenic CAR T cells will follow the same process.”
Three patients in US arm of the trial have recently had complete responses to the therapy that has extended beyond 120 days. Earlier this month Imugene announced that the first Australian patient enrolled in the trial also displayed a complete response to the azer-cel therapy at their 28-day scan.
Ms Chong said the RPA would hopefully be the first of many Australian sites involved in the trial.
“Achieving first patient dosed for azer-cel in Australia represents a significant milestone for Imugene and for Australian patients battling this devastating disease,” she said.
“The trial’s opening at RPA in Sydney reflects our commitment to accelerating the development of innovative, off-the-shelf immunotherapies that have the potential to improve outcomes for patients with relapsed or refractory DLBCL.” they said in a statement.
Additional trial sites in Melbourne, Brisbane and other parts of Sydney are expected to be recruiting patients by April.
