Martine Elias, Executive Director

CAR-T has shown promising results in the early phase of clinical trials with patients heavily pretreated who now face a relapsed or refractory myeloma. However, to properly evaluate short and long-term risks and benefits, more studies are needed.

CAR-T is a treatment currently under clinical trials whereby a person's T-cells (a type of immune system cell) are taken from their blood, modified in the laboratory into CAR-T cells so they can identify and attack cancer cells. Large numbers of these CAR-T cells are then grown in the laboratory and infused back into the patient. For myeloma patients, the CAR-T cells target and bind to B-cell maturation antigen (BCMA), a protein that is found on the surface of myeloma cells, leading to myeloma cells death.

Myeloma Canada is hopeful that the results of the early phase of clinical trials will be maintained through more multi-centre Phase III trials. We are working closely with the pharmaceutical companies involved in CAR-T research to encourage more trials and study centres to be opened in Canada. Right now, only one Canadian hospital, Princess Margaret Cancer Centre in Toronto, is participating in a CAR-T clinical trial. Myeloma Canada will continue to inform the Canadian myeloma community of any new myeloma CAR-T trials opening in Canada.

Image from the Dana-Farber Cancer Institute

(https://www.dana-farber.org/cellular-therapies-program/car-t-cell-therapy/how-car-t-cell-therapy-works/)

Challenges CAR-T Therapies Represent in Canada:

The Role of Clinicians and Patients

We face many challenges with this new technology, the first being that Health Canada’s review of this treatment will differ from the usual drug review process because CAR-T is a biological procedure that involves many complex cellular manipulations. When it comes to reimbursement recommendations by health technology agencies, it is also viewed as an intervention and not a drug. Consequently, it will be reviewed by the Canadian Agency for Drugs and Technologies in Health (CADTH) under the scope of “medical devices and clinical interventions”. This differs from how cancer drugs are usually reviewed, a process that is the responsibility of the pan-Canadian Oncology Drug Review (pCODR).



The clinical trial landscape has also proven to be an extremely competitive environment for this innovative and cutting-edge treatment and Canada is competing with other countries for trial allocation. Moreover, the fact that cancer centres are required to complete a certification to perform CAR-T presents an additional hurdle.



Canadian clinicians and investigators should continue to collaborate with international investigators, and to work with their pharmaceutical partners in order to bridge the gaps and bring “made-in-Canada” CAR-T clinical trials to various centres across the country. They, together with myeloma patients, can continue to work together to keep the myeloma community informed and educated about CAR-T and its role in the Canadian treatment landscape. With this, we will all be able to “hit the ground running” when called upon by CADTH to provide patient and clinician input in the approval review process…and that’s only the first step.

Martine Elias

Executive Director