"Yescarta leads DLBCL Tx…CAR-T therapy in earlier lines"

Approved for both second- and third-line treatment…in response to unmet needs for relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL)

"Demonstrated improvement in OS…the treatment effect is maximized when used earlier in the treatment sequence"

The market position of CAR-T cell therapy in the treatment of relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) is rapidly expanding.

 

Notably, Yescarta has secured approval in Korea for both second- and third-line treatment, drawing attention as a treatment option that has proven survival benefits over the conventional standard therapy.

 

On November 20, Gilead Sciences Korea held a press conference at its headquarters in Jung-gu, Seoul, to share the role and clinical value of Yescarta (axicabtagene ciloleucel) in the treatment of DLBCL.

 

Yescarta received approval last August for: ▲adult patients with DLBCL who relapsed or were refractory within 12 months of first-line chemoimmunotherapy ▲patients with relapsed or refractory DLBCL and Primary Mediastinal B-cell Lymphoma (PMBCL) after two or more lines of systemic therapy.

 

Yescarta is a CAR-T cell therapy that involves harvesting a patient's T cells, genetically reprogramming them to target CD19 on cancer cells, and then reinfusing them.

 

It is the first CAR-T therapy approved in Korea for both second and third-line treatment.

 

Since its first approval for follicular lymphoma in 2021, Yescarta has successfully secured market adoption by rapidly expanding its indications to DLBCL, leukemia, and others.

 

Its global sales reached $1.57 billion (approximately KRW 2 trillion) last year, making it the only CAR-T therapy to surpass $1 billion in annual revenue.

 

Sungeun Kim, Medical Lead at Gilead Sciences Korea

The domestic approval of Yescarta is based on the ZUMA-7 clinical trial, which compared the efficacy and safety of CAR-T against conventional standard therapy.

 

The clinical results showed that the median Event-Free Survival (EFS) in the Yescarta group was 8.3 months, which was more than 4 times longer than in the high-dose chemotherapy and autologous hematopoietic stem cell transplantation (ASCT) group.

 

The percentage of patients surviving without disease progression or additional treatment at two years was also 41% in the Yescarta group, 2.5 times higher than the 16% in the standard therapy group.

 

The efficacy was consistently observed even in high-risk subgroups, including elderly patients, first-line refractory patients, and patients with double-hit or triple-hit lymphoma.

 

Sungeun Kim, Medical Lead at Gilead Sciences Korea, said, "Yescarta has been supplied to over 31,000 patients worldwide and is a treatment with a stable foundation in terms of manufacturing success rate," and added, "We have submitted the application for reimbursement listing and will do our best to ensure supply in the first half of next year." High unmet need in relapsed/refractory DLBCL…will CAR-T be the solution? DLBCL is a disease where B cells, which protect the body, grow or proliferate uncontrollably.

 

It is the most common B-cell lymphoma, accounting for approximately 40% of non-Hodgkin lymphomas, and is characterized by aggressive, rapid progression.

 

The number of DLBCL patients in Korea was 14,183 as of last year, up 36% from 10,428 in 2018.

 

Up to 15% of patients fail treatment after the first-line standard therapy, and even 25% of patients who achieve complete response (CR) experience relapse within 18 months.

 

Patients with relapsed or refractory DLBCL typically see a rapid worsening of prognosis as the number of treatment lines increases.

 

The current first-line treatment for DLBCL is the chemotherapy 'R-CHOP' (rituximab, cyclophosphamide, vincristine, prednisone), which uses a monoclonal antibody combination.

 

While R-CHOP offers curative potential for about half of patients, the remainder are refractory or relapse due to poor prognostic factors.

 

Professor Gi June Min of Seoul St.

 

Mary

Subsequent treatment options include high-dose chemotherapy or ASCT.

 

However, due to the physical burden, these options are difficult for elderly or frail patients.

 

In reality, only about 30-40% of patients who respond to salvage chemotherapy can even be considered for ASCT, and half of those are known to relapse after the transplant.

 

Although CAR-T therapies like Kymriah and bispecific antibodies are used after second-line treatment, Yescarta is the only treatment in Korea to secure the second-line indication.

 

This has intensified calls from experts to apply CAR-T therapy as early as possible in patients at high risk of relapse or refractoriness.

 

Professor Gi June Min of Seoul St.

 

Mary's Hospital's Division of Hematology said, "CAR-T therapy is a priority recommended treatment for patients who relapse within 12 months," and emphasized, "Yescarta, which has confirmed improvement in OS, is a good drug that should be used earlier in the treatment sequence to maximize its effect."