Australian hospital joins Johnson & Johnson CAR-T trial

Pharma News: About 20,000 people in Australia are living with myeloma at any one time and it accounts for 15% of blood cancers. Princess Alexandra Hospital (PAH) has become the first hospital in Queensland to participate in an international cancer trial aimed at treating patients with CAR-T cell therapy from the onset of their myeloma diagnosis.

The multiple myeloma trial, known as CARTITUDE-6 and spearheaded by Johnson & Johnson Innovative Medicine (Janssen), is a 15-year longitudinal study. It seeks to replace bone marrow transplant with CAR-T therapy, specifically Carvykti (ciltacabtagene autoleucel), which was recently recommended for funding by the Medical Services Advisory Committee (MSAC).

Dr Emad Abro, a haematologist and the lead for the site study at PAH, said “CAR-T (Chimeric Antigen Receptor) cell therapy has been previously trialled in Australia with patients who have relapsed, but this is the first time in Australia that we have a study targeting patients at the start of their cancer treatment.”

After four months of standard cancer treatment – including daratumumab, bortezomib, lenalidomide, and dexamethasone (DVRd) – patients in the CAR-T trial will receive reprogrammed CAR-T cells and transition to a maintenance treatment phase, where they will be monitored over the next 15 years.

“The goal is to control the cancer with the initial chemotherapy and follow it up with the CAR-T treatment to suppress the sub-microscopic disease, which we sometimes can’t even detect,” Dr Abro explained.

“The first goal is to get the patient in remission and cleared of symptoms of the cancer. Our next goal is to maintain remission and suppress the symptoms for as long as possible.”

Dr Abro highlighted the advantages of CAR-T therapy, particularly its targeted, single-dose nature, which could lower the risk of long-term side effects associated with more toxic treatments.

“Factors like age and comorbidities can affect a patient’s ability to sustain bone marrow transplant, which has an associated 5% to 10% mortality rate. The beauty of CAR-T is that it can be adjusted in future to attack different cancer cells, making it a very targeted approach, unlike chemotherapy or bone marrow transplants which have a lot of effects in the body,” he stated.

Michael Johns, the fifth patient recruited for the PAH study, shared his experience after being diagnosed with myeloma at just 58 this April.

“I’m still in a bit of shock at my diagnosis because I’ve had a really good run of health in my life, but every week I get more information and it gives me optimism for a long remission and quality of life,” he said.

“I’m in awe of the care, the skill, the professionalism and the information provided by everyone here at PAH. Every piece of the treatment has been explained logically, it’s not been invasive in any way, and that’s helped me stay mentally positive because I’m well informed all the way along. I’m really optimistic about the future, and this trial is feeding that optimism that I’ll have a good, happy and healthy retirement.”

While the long-term outcomes of CAR-T cell therapy are still being evaluated, Dr Abro expressed cautious optimism about its potential.

“This study is very important in that it has a very long follow-up, and that enables us to track how well the treatment works, as well as the long-term safety and wellbeing of the patients,” he explained.

“Myeloma is not yet a curable disease, but we are now developing the tools that bring a lot of optimism. With treatments like the CAR-T and some of the other new medicines coming on board, we may potentially cure some patients.”

The study is a strong reminder of the important link between clinical trials and progressing cancer treatment.

“We don’t know if this will be the study to achieve a cure, but it’s a big step in the right direction. With tools like this plus additional studies, we can find combinations of treatments that will actually improve patient outcomes.

“Progressing our patients’ treatment through clinical trials is not just something we aspire to, but something we believe should be the standard of care,” Dr Abro commented.

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