Gilead Sciences is getting ready to move CAR-T up the ladder in Korea.

Next year, the company plans to launch Yescarta as the first therapy in the country cleared for both second- and third-line diffuse large B-cell lymphoma (DLBCL), putting pressure on payers and hospitals to decide how early they are willing to fund a one-shot attempt at cure.

Korea’s Ministry of Food and Drug Safety approved Yescarta, or axicabtagene ciloleucel, in August for adults who relapse or fail within 12 months of first-line chemoimmunotherapy and for adults with relapsed or refractory DLBCL or primary mediastinal large B-cell lymphoma after at least two prior systemic regimens. 

DLBCL is the most common fast-growing B-cell lymphoma and the dominant aggressive non-Hodgkin lymphoma subtype in Korea.

At a media briefing in Seoul on Thursday, Gilead Sciences Korea said it is targeting commercial supply in the first half of next year, starting with hospitals that complete Kite Pharma’s accreditation as CAR-T centers.

“We are working toward first-half supply,” said Kim Sung-eun, medical affairs director at Gilead Sciences Korea. She framed the launch as an early test of how quickly Korea is willing to move CAR-T, or chimeric antigen receptor T-cell therapy, into earlier lines of care. 

Yescarta will follow Novartis’ Kymriah (tisagenlecleucel) into the Korean CAR-T market but with a broader label, positioned as an alternative to platinum-based “salvage” chemotherapy followed by autologous stem cell transplant, a regimen that uses intensive chemotherapy and then rescues the bone marrow with the patient’s own stem cells.

A shrinking survival window after R-CHOP

For now, most Korean patients with newly diagnosed DLBCL still start on R-CHOP, a long-established drug cocktail that combines the antibody rituximab with four chemotherapy agents. 

About 60 percent can be cured with that initial regimen, according to Professor June Min-gi of the Catholic Hematology Hospital and director of the Lymphoma Center at Seoul St. Mary’s Hospital, who spoke at the session. The rest relapse or never respond. 

In pooled analyses such as SCHOLAR-1, many of those patients do not respond to subsequent systemic therapy and median overall survival is measured in single-digit months. “From the second line on, the curve falls very fast,” June said.

With each additional line of therapy, median survival dropped from roughly nine months after second line to under five months after third. For patients who relapse within a year of finishing R-CHOP, June said, doctors “cannot honestly guarantee that additional chemotherapy will change the course of the disease.”

High-dose chemotherapy followed by autologous stem cell transplant remains an option for a subset of fit patients who respond to platinum-based salvage regimens. 

On paper, it still anchors second-line treatment algorithms. In reality, many Korean DLBCL patients are older or have already been weakened by prior treatment.

A sizable fraction never achieve enough tumor shrinkage to even reach transplant. Those who do often relapse again and face transplant-related toxicity and graft-versus-host complications that can severely affect quality of life. 

“Only a minority can actually go to transplant and stay in remission,” June said. “The rest are still cycling through cytotoxic chemotherapy without a clearly effective strategy.”

That is the space where Korean hematologists are now trying to pull CAR-T forward, particularly for patients who relapse or fail within 12 months of first-line therapy.

The Korean approval rests on ZUMA-7, a phase 3 trial that pitted second-line Yescarta against the standard sequence of platinum-based chemotherapy and autologous transplant in adults with early relapsed or refractory DLBCL. 

Yescarta substantially prolonged the time patients lived without progression or the need for new treatment and improved overall survival. Even after more than half of patients in the control group later received a CAR-T therapy in third line, their survival never matched those treated with Yescarta earlier, a divergence Gilead now cites as evidence that timing is critical. The trial, Kim said, suggests that timing “matters as much as the drug.”

Speed, safety and the manufacturing pitch

Gilead’s second major selling point is operational. Korean clinicians who used Kymriah in the first wave of CAR-T adoption are familiar with “vein-to-vein” times that can stretch to roughly 40 days or more once government approvals, shipping and manufacturing are taken into account. The vein-to-vein time refers to the total time from the collection of a ptient's blood to the injection of personalized CAR-T. 

For patients with refractory DLBCL, that delay can be decisive. Many view CAR-T as their only realistic path to long-term survival. Any delay, June said, “feels endless,” and doctors can control disease with “bridging” chemotherapy only for so long before it breaks through again.

Kim argued that Kite’s manufacturing network can compress that timeline. For Korean patients, leukapheresis, the process of collecting white blood cells, will be followed by refrigerated rather than frozen storage, with cells shipped to Kite factories within about 70 hours.

Gilead is targeting a vein-to-vein time of roughly three to four weeks once the process is fully established.

On safety, both Gilead and clinicians at the session stressed that cytokine release syndrome, a systemic inflammatory reaction that can cause high fever and low blood pressure, and neurotoxicity, CAR-T-related effects on the brain, remain real risks but are increasingly well managed.

Serious toxicities are now seen in a minority of patients and, June said, most events in the first week or two after infusion can be handled with standard protocols.

The remaining questions are financial and structural rather than scientific. Yescarta’s list price has not been disclosed in Korea, but CAR-T therapies are routinely priced in the hundreds of thousands of dollars in other markets. 

Gilead submitted a reimbursement application to the Health Insurance Review and Assessment Service shortly after approval.

Kim said Korean health authorities recognize the unmet need in early relapsed DLBCL and broadly accept that more options are necessary, but she declined to discuss details of price talks or to predict when a decision might come.

For Gilead, second-line reimbursement is the central prize. Even without it, some major Korean centers are expected to offer Yescarta as a self-pay option for select patients once supply begins, given the severity of the disease and scarcity of alternatives, but volumes in that scenario would be limited. 

The company’s rollout plan starts with large tertiary hospitals that already function as CAR-T hubs and must complete Kite’s certification program. Over time, Gilead says it will work with professional societies and regulators to widen access while maintaining consistent standards.

For June, the calculus is simple. DLBCL is an aggressive disease and the window for cure is narrow. If a treatment can cure more patients, he said, it should not be saved “for the fifth or sixth line.” The challenge now, he added, is to make early CAR-T “a real option for the patients who need it, not only for those who can pay for it out of pocket.”