“With the development of domestically produced CAR‑T (chimeric antigen receptor T‑cell) therapies, local manufacturing has become possible. Because CAR‑T is made by collecting the patient’s own immune cells, ‘T cells’, overseas therapies require about six weeks, but with domestic production this can be significantly reduced to under four weeks.”

At Seoul Asan Medical Center on 1 June, Professor Cho Hyeong‑woo of the Department of Oncology explained the significance of “Limcato”, a new domestic CAR‑T drug approved in April this year. CAR‑T is an anticancer therapy created by collecting T cells, a type of the patient’s immune cell, and genetically engineering them so that they attack only cancer cells. It is particularly effective in lymphoma, a type of blood cancer, and is referred to as a “dream cancer drug.”

However, unlike conventional anticancer drugs, CAR‑T is made using the patient’s T cells, so the time required from cell collection to infusion, which exceeds one month, is considered a major barrier. Currently in Korea, a total of four CAR‑T therapies have been approved: “Kymriah” from Novartis, “Carvykti” from Janssen, “Yescarta” from Gilead, and “Limcato” from domestic biotech company Curocell. Except for Limcato, all are therapies developed by global pharmaceutical companies based overseas.

Although there are differences among the therapies, the disease commonly designated as a treatment target by all except Carvykti is diffuse large B‑cell lymphoma (DLBCL), an aggressive lymphoma with a rapid progression rate. Because cancer cells attack quickly, prompt treatment is critical.

Professor Cho stated, “Reducing the time to infusion from six to eight weeks down to four weeks may not appear highly significant, but there are many patients who cannot withstand that waiting period,” adding, “In terms of efficacy, Limcato is not inferior to overseas CAR‑T therapies, and it is meaningful that the time to administration has been shortened.”

In the Phase 2 clinical trial that supported its approval, Limcato recorded an objective response rate (ORR) of 75.3% and a complete response rate (CR) of 67.1%, strong results. The objective response rate is the proportion of patients whose tumor size is reduced by at least a certain level after receiving the therapy, and the complete response rate is the proportion of patients in whom no trace of the tumor can be detected.

Limcato in particular has drawn significant attention for achieving a higher complete response rate than other therapies, a meaningful indicator in blood cancers. Professor Cho noted, “Because blood cancers are spread throughout the entire body, unlike solid tumors, not a single cancer cell can remain,” describing Limcato’s complete response rate as “encouraging.”

Despite these strong outcomes, patients who wish to receive Limcato still face the hurdle of reimbursement. Because CAR‑T is a personalized therapy, the cost is extremely high, in the KRW 300 million to KRW 500 million range. Currently, the only CAR‑T therapy reimbursed under the Korean system is Kymriah. Professor Cho said, “Because CAR‑T is highly effective, there are cases in which serious adverse events such as neurotoxicity accompany treatment, so expanding patients’ treatment options is very important,” adding, “In practice, if reimbursement is not approved, medical staff cannot recommend a therapy that may be more suitable for the patient, so there is a strong desire to see broader reimbursement.”

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