New drugs, such as immunotherapy, have been introduced as the first-line treatment for urothelial carcinoma, which was primarily treated with platinum-based chemotherapies. The treatment landscape for the disease is constantly evolving.

As more treatment options became available, doctors are now discussing the optimal treatment for each disease stage to establish the standard therapy.

Discussions about being made about curative intent, in other words remission, in the long term. Dr. Enrique Grande, professor at MD Anderson Cancer Center Madrid, and Dr. In-ho Kim, professor at Seoul St. Mary's Hospital, have discussed the treatment landscape and unmet needs of urothelial carcinoma.


Urothelial carcinoma (UC) is a type of cancer that begins in the epithelial cells lining the urinary tract and accounts for approximately 90% of all bladder cancer diagnoses, making it the most common form of bladder cancer.

Unlike other cancer types, such as lung and breast cancer, where the introduction of new drugs has rapidly transformed first-line standard treatments, UC has historically been viewed as a challenging area for anti-cancer drug development, with substantial unmet needs for first-line treatment options.

"The treatment landscape has been changing in the past few years. The treatments are now targeting various types of patients, including metastatic UC patients and management of surgical cycles for patients with muscle-invasive bladder cancer (MIBC)," Dr. Grande said.

"The maintenance treatment Bavencio plays a significant role in the UC treatment landscape in South Korea," Dr. Kim said. "The enfortumab vedotin+pembrolizumab combination therapy and nivolumab+gemcitabine+cisplatin combination therapy have been approved as first-line treatments in South Korea, offering various treatment options for patients with UC."

Additionally, significant advancements in the field have been made, including the approval of therapies such as enfortumab vedotin monotherapy and erdafitinib monotherapy for second-line or later treatments in South Korea.

The first-line maintenance treatment Bavencio continues to generate sales…"Expected to play a significant role in South Korea"

How are these various options utilized in clinical practice? Dr. Grande emphasizes that patients prioritize achieving treatment effects and improving their quality of life.

"Patients with UC are typically heavy smokers in their 60s to 70s with accompanying chronic diseases, and the cancer is often detected before extensive metastasis has occurred," Dr. Grande said. "Treatment begins with chemotherapy to achieve therapeutic efficacy while maintaining quality of life, followed by first-line maintenance therapy options like Bavencio."

Dr. Grande stressed the importance of using safe, low-toxicity treatments over long-term use, allowing patients to maintain their quality of life while receiving treatment safely.

While the number of available treatment options in South Korea has increased, Bavencio as a first-line maintenance therapy still plays a critical role when considering the reimbursement in practices.

"Many options have been introduced to the treatment landscape for UC. However, in South Korea, Bavencio maintenance therapy continues to play a crucial role and is expected to remain a key option for a significant period," Dr. Kim said. "Bavencio is currently the only reimbursed first-line maintenance therapy option for UC in South Korea."

In fact, Bavencio's data has been accumulating. Bavencio's company presented the SPADE study at ESMO Asia earlier this December, reaffirming the drug's efficacy and safety as a first-line maintenance therapy for patients with locally advanced or metastatic UC.

The SPADE study is the first prospective study to evaluate the efficacy of Bavencio as a first-line maintenance therapy in the Asia-Pacific (APAC) region.

Interim analysis results showed that at the 12-month final follow-up, 61 patients (67.0%) who received first-line chemotherapy treatment proceeded to Bavencio first-line maintenance therapy. Additionally, 72% of patients who received Bavencio maintenance therapy subsequently received second-line treatments.

Additionally, the Bavencio study demonstrated safety through global clinical trials, showing a low incidence of adverse events during the treatment period and extending the quality-adjusted time without symptoms or toxicity (Quality-TWIST) to more than double compared to best supportive care (BSC).

"A comparison between Bavencio combination therapy and optimal supportive care revealed no significant difference in the quality of life between the BSC and Bavencio combination therapy groups. These outcomes show an excellent tolerability profile for Bavencio maintenance therapy," Dr. Grande said.

"Although the results were from a subgroup analysis, Bavencio as a first-line maintenance therapy used for one or two years has demonstrated significant clinical survival benefits," Dr. Grande remarked. "The proportion of patients who die within a short period is less than 10–20%, making the continuation of Bavencio as a first-line maintenance therapy after chemotherapy the optimal scenario."

"Various changes to treatment options for UC…curative intent approach must be discussed"

A common concern among UC treatment experts is identifying the characteristics of patient groups capable of achieving long-term survival.

Dr. Kim highlighted the importance of considering both an individual’s health status and their socioeconomic environment.

Dr. Kim stated that simplifying treatment sequences could improve patient tolerability rather than repeatedly administering multiple therapies over an extended period.

Dr. Kim said, "Palliative treatments aimed at prolonging life are important, and there are instances where patients achieve a cure while receiving maintenance therapy with treatments such as Bavencio." Adding, "I believe that for urothelial carcinoma to ultimately achieve the goal of curing cancer, the field of curative treatment must advance further."

"In the current treatment landscape for UC, various novel therapies and combination regimens with different mechanisms are being introduced. However, we need more time to observe the real-world clinical effects of these newly introduced treatment options," Dr. Kim said.

Additionally, Dr. Grande highlighted the importance of biomarker studies and multidisciplinary approaches to seek optimal treatment options.

"We hope to establish a biomarker that can be utilized across treatment planning to surgical cycles and be used towards practices. There are many factors to consider when treating patients. A multidisciplinary approach involving urology, medical oncology, radiology, and nuclear medicine is essential," Dr. Grande remarked.