Access to later-line therapy for kidney cancer remain unchanged

Treatment environment shifting toward the use of immuno-oncology drugs

Limitations in the reimbursement system restrict second-line treatment access

Although treatment for advanced renal cell carcinoma (kidney cancer) is rapidly shifting toward immuno-oncology-based combination therapies, Korea’s treatment environment still lags behind global guidelines.

In particular, even after immunotherapy combinations became established as first-line standard treatments, access to second-line therapies following disease progression remains limited. As a result, advances in treatment outcomes are not being fully translated into continuity of care for actual patients.

On the 26th, Ipsen Korea held a press conference at the JW Marriott Hotel in Seocho-gu, Seoul, in celebration of World Kidney Cancer Day in June, highlighting the current treatment environment and patient access challenges in renal cell carcinoma. At the event, quality-of-life issues faced by kidney cancer patients and their families, along with the limitations of the domestic second-line treatment environment following immunotherapy, were presented as key topics.

In Ho Kim, a professor of Medical Oncology at Seoul St. Mary’s Hospital, explained, “Renal cell carcinoma is one of the cancer types that has seen the most rapid advancements in treatment over the past decade. Thanks to advances in immunotherapy and targeted therapy, treatment environments now allow not only long-term disease control but also long-term survival in some patients.”

Renal cell carcinoma is the most common type of kidney cancer, accounting for approximately 90% of all cases. While it often presents with no specific symptoms in the early stages, as the disease progresses, symptoms such as hematuria, flank pain, and fatigue may appear. In advanced stages, a cure through surgery alone is difficult, making drug therapy the cornerstone of treatment.

Shift toward immunotherapy combination strategies…changes in first-line treatment strategies

Professor In Ho Kim, Department of Medical Oncology, Seoul St. Mary’s Hospital

Current treatment strategies for advanced renal cell carcinoma are selected based on patient risk categories. In clinical practice, physicians use the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk classification to divide patients into favorable-, intermediate-, and poor-risk groups. In intermediate- and poor-risk groups, immunotherapy-based combinations have effectively become the global standard.

Professor Kim stated, “In the past, treatment focused on targeted therapy monotherapy, but immunotherapy combinations have changed the treatment paradigm. Particularly in the intermediate and poor-risk groups, the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) has demonstrated survival benefits and established itself as a major first-line treatment strategy.”

Currently, the first-line immunotherapy combinations approved in Korea for renal cell carcinoma include: ▲Opdivo + Yervoy ▲Opdivo + Cabometyx (cabozantinib) ▲Keytruda (pembrolizumab) + Lenvima (lenvatinib) ▲Keytruda + Inlyta (axitinib). Combinations involving immunotherapy plus immunotherapy or immunotherapy plus targeted therapy have improved survival rates and disease control compared to conventional targeted therapy monotherapy approaches, driving major changes in renal cell carcinoma treatment strategies.

However, Korea’s reimbursement environment is considered insufficient to keep pace with treatment advances. Currently, the only reimbursed immunotherapy combination is Opdivo + Yervoy for IMDC intermediate- and poor-risk patients. Insurance coverage is also limited to a maximum of 2 years. In contrast, immunotherapy plus targeted therapy combinations widely recommended in global treatment guidelines are not reimbursed.

Limitations in access to follow-up therapy highlighted

The problem lies in the period following first-line immunotherapy. While many patients in Korea currently use the Opdivo plus Yervoy combination therapy, which is covered by insurance, the options available for subsequent treatment after disease progression are limited.

In Korea, reimbursable drugs for second-line renal cell carcinoma treatment are limited to certain VEGF-targeted anticancer agents, such as Sutent (sunitinib), Votrient (pazopanib), and Inlyta. Meanwhile, Cabometyx, which is recommended as a key subsequent therapy option in international guidelines, is not only non-reimbursed but also limited in actual use.

International guidelines from the NCCN, ESMO, and EAU recommend cabozantinib as a major follow-up treatment option after first-line immunotherapy-based therapy. However, Korean approval is limited to ‘advanced renal cell carcinoma patients previously treated with VEGF-targeted therapy.’ As a result, patients who received immunotherapy combinations in the first line face structural barriers to using Cabometyx under the current label.

Cabometyx demonstrated improvements over everolimus in progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) in the METEOR study. Median PFS reached 7.4 months, OS was 21.4 months, and ORR was 24%, confirming clinical efficacy across all three major endpoints in second-line renal cell carcinoma treatment.

Kim stated, “While patients in Korea frequently use the Opdivo plus Yervoy combination therapy as first-line treatment, there remains a structural gap that makes it difficult to naturally transition to evidence-based follow-up treatment afterward.”

He further emphasized, “To translate the treatment outcomes of renal cell carcinoma into real-world patient care, we need to discuss improving access not only to first-line treatment but also to subsequent lines of therapy to ensure continuity in treatment.”