Bavencio’s reimb may change the Rx paradigm in KOR

May change the first-line treatment pattern for metastatic urothelial carcinoma

Demand for later-line treatments such as Padcev still remain

Changes are arising in the prescription pattern for metastatic urothelial cancer due to the emergence of new treatment options.

 

The reimbursement of Bavencio (avelumab) as a first-line maintenance therapy, increased treatment options for the patients.

 

The drug was first granted reimbursement only as a second-line treatment.

 

As demand for maintenance therapy has been high in the field, experts believe the prescription pattern will also change rapidly with Bavencio's reimbursement.

 

Pic of Bavencio

# Urothelial carcinoma begins in the urothelial cells and is the most common type that accounts for 90% of all bladder cancer diagnoses.

 

Platinum-based chemotherapy, which has been the standard of care in the field for the past 30 years, showed a response in 3 out of 4 patients, but overall survival and progression-free survival were only around 12-15 months and 6-8 months, respectively.

 

Also, the rate (25%) of patients using second-line chemotherapy was low, indicating the high unmet need for a viable treatment option after first-line chemotherapy.

 

This is why the reimbursement of Bavencio (avelumab) from August as first-line maintenance therapy for adult patients with locally advanced or metastatic urothelial carcinoma is being received such high expectations.

 

Bavencio was found to delay disease progression in the randomized, multicenter, open-label JAVELIN Bladder 100 study that studied 700 patients with locally advanced or metastatic urothelial cell carcinoma from 29 countries including Korea for over 38 months.

 

Study results showed that the median overall survival (OS) of patients who received Bavencio was 29.7 months (25.2-34.0), a 9-month extension compared to patients who received best supportive care (BSC) care alone (20.5 months, 19.0-23.5), and patients showed over an 8-month improvement compared with the control group regardless of the first-line chemotherapy option.

 

Professor A from the Department of Oncology at one tertiary hospital, said, “30-40% of patients progress after receiving first-line treatment.

 

This means that out of 10 patients, around 7 patients will be eligible to use Bavencio as maintenance therapy.” “In the past, if 3 out of 10 patients experienced disease progression and moved on to second-line treatment, the 6 to 7 who did not progress just stayed without treatment.

 

If the patient’s condition worsened after 3 to 4 months of non-treatment, the only positive aspect was that they were able to move on and receive later-line treatments.” However, considering the characteristics of locally advanced or metastatic urothelial cell carcinoma, experts believe that attention should be paid to later-line treatment options to treat the progression of the disease.

 

The use of Bavencio may offset part of Keytruda’s use as a second-line treatment to some extent, but as the disease progresses, concern about what to use next becomes inevitable.

 

Professor Miso Kim of the Department of Hemato-Oncology at the Seoul National University Hospital, said, “It is difficult to say which is more important - maintenance therapy and later-line treatment, but we are concerned about patients who cannot receive maintenance therapy, on how to treat these patients.” As the demand for later-line treatment is still high due to the nature of the disease, doctors have been stressing the need for reimbursement of such treatments.

 

Treatments such as Padcev (ingredient: enfortumab vedotin-ejfv) that have been introduced have been raising interest in reimbursed options to use after second-line treatment.

 

At a meeting last July, Astellas emphasized the justification for reimbursement of treatments such as Padcev as third-line or later-line treatments, apart from reimbursement of treatments like Bavencio.

 

During the meeting, Kyung-Ah Park, Director of Medical Affairs at Astellas Korea, said, “We are offering drugs that can be used in a field where no 3rd-line or later-line option has been available until now.

 

Padcev is strongly recommended by NCCN or European guidelines.

 

We are working to benefit more patients by receiving reimbursement for this drug as soon as possible.” A urologist at a tertiary hospital, said, "In Korea, patients whose disease progresses after second-line rechallenge their tumor with previously treated treatments or use chemotherapy with paclitaxel.

 

Although there are limitations due to its non-reimbursed status, there is a demand for a valid later-line treatment option, apart from Bavencio's reimbursement.”