The treatment landscape for metastatic urothelial cell carcinoma has changed after Bavencio (avelumab) was granted reimbursement as a first-line maintenance therapy in Korea.

Bavencio addressed the high unmet need that had remained for a maintenance therapy option on site, rapidly changing the prescribing pattern.

Merck Biopharma Korea held a press conference celebrating the first anniversary of the reimbursed launch of its Bavencio in Korea, highlighting the changes in Korea’s prescribing environment and Bavencio’s clinical value.

The indication for the anti-PD-L1 immuno-oncology drug was expanded in August 2021 to include first-line maintenance therapy for patients with metastatic urothelial cell carcinoma whose disease has not progressed following chemotherapy, then reimbursed for the indication in August last year.

Bavencio’s reimbursement for first-line maintenance therapy was significant because it allowed the drug to be covered for patients who previously had no available treatment options following first-line therapy. For example, if there were 10 patients with urothelial carcinoma, 3-4 would progress to second-line treatment, while the remaining 6-7 whose disease had not progressed would maintain their state without receiving further treatment.

In this regard, experts have positively evaluated Bavencio’s reimbursement expansion as later lines of therapy were only conducted if the prognosis worsened after 3-4 months of non-treatment.

“Personally, I think it's useful because it treats patients well,” said Dr. Inho Kim, Professor of Oncology at Seoul St. Mary's Hospital. Kim explained that there is no reason not to proceed to maintenance therapy if the patient's condition does not worsen after chemotherapy.

Kim added, “In Korea, reimbursement is always an important factor, so patients who respond to first-line treatment will likely use the reimbursement maintenance therapy with Bavencio. In terms of treatment convenience, patients have been experiencing the benefits of the immuno-oncology drug.”

Bavencio’s efficacy was confirmed through the long-term follow-up Phase III JAVELIN Bladder 100 trial, which involved 700 patients with locally advanced or metastatic urothelial cancer in 29 countries, including Korea, for over 38 months.

The trial results showed a median OS of 29.7 months with Bavencio+maintenance therapy, which was over 9 months longer than the 20.5 months found in the maintenance monotherapy arm.

The drug has been increasing its presence after confirming its effect in the real world among Koreans through the early access program (EAP).

Patients using Bavencio through the EAP showed a median progression-free survival (PFS) of 7.9 months after starting treatment with Bavencio, which is higher than the 5.5 months reported in the long-term follow-up of the global JAVELIN Bladder 100 (JB 100) trial.

Min Jung Koh, Country Medical Director at Merck Biopharma Korea, said, “These results are the first real-world data (RWD) that confirms the clinical effectiveness and safety of Baevncio in the Korean population, demonstrating Bavencio’s consistent benefits in Korea as in global clinical trials.”

However, the changing urothelial cancer treatment landscape remains a challenge on the company’s part. While not yet reimbursed, the growing number of first-line treatment options may change Bavencio’s position as a first-line maintenance therapy in the future.

“Other drugs like Padcev have shown good results recently, and I think each drug has its pros and cons. Cost is also a consideration, and as we gain more prescription experience and accumulate more information on the patients’ conditions, we will be able to set guidelines for this.”