With the approval of the CAR-T cell therapy Yescarta (axicabtagene ciloleucel) in Korea, a shift in the treatment landscape for Diffuse Large B-cell Lymphoma (DLBCL) is anticipated.

Analysis suggests that an innovative therapeutic option that has demonstrated higher cure rates and improved survival compared to existing second-line treatments is expected to provide a new option for patients in Korea.

Gilead Sciences and Kite Pharma plan to use Yescarta's Korean approval to strengthen their cooperation with Korea's health authorities and medical institutions, focusing on addressing the unmet needs of DLBCL patients.

DailyPharm met with Diego Santoro, Head of the International Region for Kite Pharma (a Gilead Sciences company), to hear about the company's specific plans.

Diego Santoro is an expert who has led the commercialization and expansion of access for CAR-T cell therapies in key countries such as Japan, Korea, and Brazil, with over 25 years of leadership experience at global pharmaceutical companies.

Yescarta's Milestone in DLBCL Treatment..."Became a Key Treatment Option"

Diffuse Large B-cell Lymphoma (DLBCL) is a very rapidly progressing disease, with approximately 40% of patients who receive first-line treatment experiencing a relapse. Previously, the average survival period after second-line treatment was only about 6 months, but with the introduction of CAR-T therapies, survival rates have significantly improved.

Through one of the world's largest clinical studies, Yescarta demonstrated that approximately 41% of patients survive for over 5 years. Yescarta is currently approved in over 40 countries, and its reimbursement has been secured in numerous countries based on its therapeutic efficacy and financial feasibility, expanding patient access.

From this perspective, Yescarta is also expected to become an important therapeutic option that addresses unmet needs in Korea.

Diego Santoro explained, "Korean medical professionals were well-informed about Yescarta's clinical data even before its approval, and the demand for its introduction was high." He added, "The biggest differentiation factor is that it allows patients to start treatment at an earlier stage, which improves prognosis and increases the possibility of a cure. The trend in clinical practice is already shifting, with patients who were previously considered for third-line therapy now being treated at the second-line stage."

In other words, by administering CAR-T earlier at the second-line treatment stage, rather than waiting until the third-line as in the past, it is possible to suppress the cancer early and aim for a cure.

For Yescarta, which has already proven its efficacy in the global market, to secure influence in Korea, three major challenges exist: access, supply, and competing treatments. Among these, entry into the national health insurance system will be the biggest hurdle for expanding access.

Regarding this, Santoro said, "Yescarta's reimbursement application was submitted at the end of August, immediately following its domestic approval in Korea. We are currently expediting the submission of all relevant documents and are ready to enter into full-scale discussions with the government," and added, "Gilead and Kite Pharam will focus on improving patient access by collaborating closely with the government, as well as with Korean medical professionals and patient organizations."

And added, "We are fully aware of the concerns regarding the drug's price and institutional challenges. During the negotiation process, we plan to present a compelling case about Yescarta's differentiated clinical value as a second-line therapy and how earlier treatment improves patient outcomes and the possibility of a full recovery."

"Quickly applying for reimbursement...patient access is the main priority"

Another task is the supply issue. Currently, both the reimbursed CAR-T therapy Kymriah and Yescarta require harvesting the patient's cells in Korea, sending them to the U.S. for manufacturing, and then bringing the finished product back to Korea.

There is a concern that this process can delay treatment, which is critical for CAR-T patients, and potentially worsen their prognosis.

Regarding this, Santoro said, "The speed of supply is the priority for treatment outcomes with CAR-T therapies, so we prioritize it above all else." He added, "Based on the experience accumulated from treating over 31,000 patients worldwide, Gilead and Kite Pharma have achieved a CAR-T therapy manufacturing success rate of over 96%, which is the highest in the industry, and a vein-to-vein (V2V) time that is among the fastest globally."

V2V refers to the time from a patient's leukocyte collection to the infusion of the therapy. The company maintains a supply time of less than 30 days in Asia and plans to guarantee the same volume for Korea.

He said, "We ensure that the collected cells are not frozen and arrive at the manufacturing site within 72 hours. In the actual supply process, we always secure more than two backup flights to prevent any disruption to patient treatment." He stated, "We know that a difference of even 1-3 days can have a significant impact on a patient's treatment outcome, so our goal is to provide the therapy as quickly as possible."

Regarding competition with new options like recently emerged bispecific antibodies, Santoro emphasized, "In most countries, bispecific antibodies are approved as third-line therapies after CAR-T, and the guidelines from major academic societies and institutions also recommend the use of CAR-T therapies in early stages."

Aim to Become a Hub for CAR-T Therapy in Asia

Santoro views that Yescarta's approval in Korea represents not just a commercial entry but also a significant medical and scientific milestone.

He said, "Korea is a competitive country with excellent medical infrastructure and highly skilled medical professionals. The swift approval of Yescarta is expected to bring a positive change to the patient treatment environment, alongside existing anti-cancer drugs."

Kite Pharma has a strong history of collaboration with Korea's medical institutions and health authorities, as it highly values Korea's capabilities.

Based on this foundation, Kite Pharma has presented a blueprint to develop Korea into a hub for CAR-T therapy in Asia by investing in training medical professionals and strengthening hospital capabilities.

Finally, Santoro stated, "The approval of Yescarta as a second-line therapy in Korea is an important starting point that will significantly change the patient treatment environment." He added, "Based on our global experience, we will provide trustworthy and innovative treatment options to Korean patients."