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CAR-T Meeting 2022 | Preparing for the commercialization of CAR-T products

Michael Schmitt, MD, PhD, University Clinic Heidelberg, Heidelberg, Germany, talks on the introduction of chimeric antigen receptor T-cell (CAR-T) products in the clinic. Commercial CAR T-cells are currently produced for patients with diffuse large B-cell lymphoma (DLBCL) in the third-line setting. However, key clinical trials have recently demonstrated the superiority of CAR-T therapies over current standards of care in DLBCL in the second-line setting and it is expected that they will change clinical practice. In parallel, BCMA-targeted CAR-T therapies are being developed for multiple myeloma and are expected to enter clinical practice for various indications soon. This creates a number of challenges for the healthcare system and for healthcare professionals in terms of cost and infrastructure. This interview took place at the EBMT-EHA 4th European CAR T-cell Meeting which was held virtually in 2022.

Transcript (edited for clarity)

Yeah, we have a lot of move at the moment, because so far I have just talked about the research and developmental side in the field of CARs, but the commercial field is going to broaden extraordinarily.

So far, we have employed CAR-T products from industrial manufacturing only in the third-line in patients with diffuse large B-cell lymphoma. And that will change because during the last ASH Annual Meeting in December 2021, we saw, in three studies, a comparison of conventional standard of care therapy with CAR-Ts given already at the second-line...

Yeah, we have a lot of move at the moment, because so far I have just talked about the research and developmental side in the field of CARs, but the commercial field is going to broaden extraordinarily.

So far, we have employed CAR-T products from industrial manufacturing only in the third-line in patients with diffuse large B-cell lymphoma. And that will change because during the last ASH Annual Meeting in December 2021, we saw, in three studies, a comparison of conventional standard of care therapy with CAR-Ts given already at the second-line. So traditionally after R-CHOP given to the patient, we will not go to R-DHAP or an autologous stem cell transportation, but directly second-line to CARs.

For Germany, for example, my country, it means that from a yearly rate of 300 patients getting a dose in with CAR-T products that will come to an order of magnitude higher to 3000 patients here in Germany receiving the products. And that of course will be a game-changer because a lot of hospitals besides the big players, university hospitals, are thinking now about “How can we prepare for this plethora of lymphoma patients getting dosed with CD19 CAR-Ts?” and besides that they also have to prepare for administering BCMA-directed CAR-T products to multiple myeloma patients.

So what we currently see is a broadening of the field. We have another entity with myeloma, but we have a change from third-line, 3L to 2L, second-line in large B-cell lymphoma that will constitute a challenge to both the nurses and physicians working with the patients and all other people like case managers, like transplantation coordinators, to provide enough infrastructure, beds, and day clinic beds for the patient. And on the other hand it will be a challenge for the healthcare payers, because currently including the chemotherapy, the preparation and the follow-up of patients will roughly cost half a million euros. And if you multiply that with 300, you end up already with a high sum of money. And if you even multiply it with 3000, it really comes to a sum of money, which is valuable and must be counterweighted to the [inaudible] of a country.

So we will see what happens in the health system. We see already a lot of restrictions from the side of the healthcare payers as for BCMA CARs. And we will see once the market authorization in the middle of this year will be changed from third to second-line for large B-cell lymphoma.

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