"Long-term survival possible for urothelial carcinoma"

"Bavencio is the key treatment"

Professor In Ho Kim of Seoul St. Mary's Hospital's Department of Oncology -Professor Hongsik Kim of Chungbuk National University Hospital's Department of Hematology and Oncology

Real-world data (RWD) confirmed the survival improvement effects observed in the clinical study

Has the advantage in terms of safety …long-term administration is also stable

The treatment landscape for urothelial carcinoma is changing rapidly.

 

Various approaches, including immunotherapy, antibody-drug conjugates (ADCs), and chemotherapy combination therapies, have been introduced.

 

However, significant reimbursement barriers still exist in clinical practice.

 

Among these, Merck's Bavencio (avelumab) is the only first-line maintenance treatment with insurance reimbursement applied in Korea.

 

This drug has been a key treatment regimen of the long-term treatment strategy.

 

In the JAVELIN Bladder 100 study, the basis of approval, Bavencio more than doubled overall survival (OS) compared to the prior standard of care, presenting a new paradigm that moved beyond a 'watch-and-wait' strategy.

 

The latest real-world data (RWD) confirmed the clinical study, strengthening Bavencio's reliability in actual treatment settings.

 

With most urothelial carcinoma patients being older adults, cost-effectiveness and safety are crucial for long-term treatment strategies.

 

Experts' main opinion is that Bavencio is a treatment that satisfies both conditions simultaneously.

 

DailyPharm met with Professor In Ho Kim of Seoul St.

 

Mary's Hospital's Department of Medical Oncology and Professor Hongsik Kim of Chungbuk National University Hospital's Department of Hematology and Oncology to discuss the changes in the urothelial carcinoma treatment landscape and the reasons why the focus should be on long-term treatment strategies beyond just survival.

 

Long-term survival effect confirmed by real-world data Both experts cited the consistent results of Bavencio, as demonstrated in RWD, as its greatest strength.

 

RWD from multi-national studies, including the Japanese JAVEMACS, U.S.

 

PATRIOT-II, and French AVENANCE trials, showed a median OS for Bavencio of over 30 months, with some analyses reporting extended results of over 40 months.

 

Notably, a treatment strategy that continues with an ADC (such as enfortumab vedotin) after first-line Bavencio maintenance treatment has been reported to show an OS of over 41 months, substantially expanding the possibility of long-term survival for patients.

 

Professor In Ho Kim of Seoul St.

 

Mary

Professor Kim said, "In a clinical practice, it's very rare for a patient not to undergo Bavencio maintenance treatment.

 

Except for a few patients who have difficulty adapting to immunotherapy, most are being treated with Bavencio maintenance therapy." Professor Kim added, "It is difficult for clinical trial data to become part of actual patient care, but Bavencio is an exception.

 

The results from the clinical setting and the real world are almost identical." He assessed that "this drug provides a foundation for patients to continue treatment for a long time without difficulty." Professor Kim emphasized, "Because Bavencio has only a few side effects, it allows patients to continue therapy.

 

Since patients feel comfortable with Bavencio maintenance treatment, long-term treatment is possible," and noted, "In clinical practice, patients are often in poorer health or are older than those in clinical trials, so we believe Bavencio's biggest advantage is that it can be used to treat these patients without difficulty." Data from Korea also supported these findings.

 

An analysis of an Expanded Access Program (EAP) involving 30 patients from five Korean hospitals from 2021 to 2023 showed a median progression-free survival (PFS) of 7.9 months from the start of Bavencio, surpassing the 5.5 months in the JAVELIN Bladder 100 study.

 

The complete response (CR) rate was 20%, and the median duration of CR reached 17.8 months.

 

The fact that the results were consistent with global outcomes despite unfavorable conditions, 67% of patients were Stage 4 at diagnosis, and 40% had visceral metastasis, is highly significant.

 

This also serves as the reason why Bavencio quickly became the standard of care for first-line maintenance therapy for urothelial carcinoma after its reimbursement application.

 

Professor Kim said, "Clinical trials mainly include young, healthy patients, but in real-world practice, the majority of patients are older adults, with an average age of over 70." He added, "It is significant that the same survival curve appeared in this patient population as in the clinical trials." And he added, "Because Bavencio has few side effects, even patients in their mid-80s can use it without burden.

 

When patients transition from platinum-based chemotherapy to Bavencio maintenance treatment, most see their condition improve after treatment, allowing them to proceed to second-line treatment, and there are many cases of long-term survival.

 

The positive results confirmed in clinical trials are being directly translated into patient treatment." Professor Kim also mentioned, "In clinical settings, the effect was maintained even in patients with chronic kidney disease who were on dialysis.

 

It has been confirmed that Bavencio maintenance treatment significantly improved patients' quality of life." First-line maintenance treatment as a practical alternative to reimbursement barriers While the number of urothelial carcinoma patients is steadily increasing in Korea, the treatment environment remains challenging.

 

The recurrence rate after platinum-based chemotherapy is high, and immunotherapy as a monotherapy is not guaranteed to extend survival in the long term.

 

Currently, various options are available for first-line urothelial carcinoma treatment.

 

For example, combination therapies with immunotherapy and ADCs, as well as combination therapy with nivolumab + GemCis (gemcitabine + cisplatin).

 

However, the ADC combination therapy is not covered by reimbursement, and the nivolumab and GemCis combination therapy is only reimbursed for a limited number of drugs.

 

Bavencio maintenance therapy is currently the only option with reimbursement in Korea and is the most widely used in real-world clinical practice.

 

Professor Hongsik Kim of Chungbuk National University Hospital

Professor Kim said, "Because I work at a regional hospital, I prioritize minimizing the financial burden on patients.

 

I prefer treatments that are covered by reimbursement for long-term use.

 

Consequently, we most often use gemcitabine-based platinum chemotherapy, followed by Bavencio maintenance treatment.

 

If the disease progresses after Bavencio maintenance therapy, we use treatments like paclitaxel." He added, "On the other hand, for treatments like ADC, there isn't enough long-term sequencing data.

 

Among the treatments currently used for urothelial carcinoma, Bavencio has the most abundant sequencing data, which provides a foundation for patients to receive stable Bavencio maintenance therapy for a long time in a clinical setting." The experts commonly pointed out that the future treatment paradigm should shift beyond simple life extension to a 'long-term treatment strategy.' Professor Kim explained, "What is particularly noteworthy in the urothelial carcinoma treatment landscape is that the number of second-line and later treatment options has increased significantly compared to the past.

 

While immunotherapy monotherapy dominated in the past, a variety of new treatments have emerged, giving patients many more choices.

 

I think this is a very fortunate change in the clinical setting." He continued, "With other immunotherapies and new drug candidates accumulating clinical evidence, a reimbursed first-line maintenance therapy is the most practical alternative for patients.

 

Like other immunotherapies, Bavencio has a two-year limit on reimbursement.

 

This drug can be administered for a long time until intolerance occurs.

 

I understand the intent of the system, but since many patients remain stable for more than two years, I believe a separate discussion is needed based on individual patient circumstances." Finally, Professor Kim added, "Since Bavencio became reimbursed, many patients have had fewer worries during their treatment.

 

Patients often place more value on a treatment-providing environment than on the drug itself.

 

While various new drugs are being developed, I believe Bavencio will continue to play an important role in the urothelial carcinoma treatment."