New ADC drug Padcev seeks reimb again in Korea

New ADC drug for urothelial cancer

Astellas applied for reimbursement listing last month after rejection in February

Attention focused on whether the company’s third attempt will be successful... remains non-reimbursed over 2 years in South Korea

The ADC bladder cancer drug Padcev is once again attempting reimbursement listing in Korea.

 

According to Dailypharm coverage, Astellas Pharma Korea recently submitted a reimbursement application for its antibody-drug conjugate (ADC) Padcev (enfortumab vedotin).

 

Accordingly, it will be interesting to see whether the company will be able to make progress in the discussion on insurance reimbursement for Padcev as a monotherapy and combination therapy.

 

This is the company’s third attempt at reimbursement listing.

 

Padcev was first approved in Korea in March 2023, and has remained non-reimbursed for over 2 years since.

 

The monotherapy option passed the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee review in February this year, but the application was rejected after the government and pharmaceutical companies failed to agree on the cost-effectiveness after the company completed the pharmacoeconomic evaluation.

 

At the end of last year, Astellas Pharma applied for Padcev’s reimbursement as a monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have previously received PD-1 or PD-L1 inhibitors and platinum-based chemotherapy, and as first-line therapy for advanced metastatic urothelial carcinoma in combination with the PD-1 inhibitor ‘Keytruda (pembrolizumab)’ However, the applications were also rejected by the Cancer Disease Deliberation Committee in February.

 

Astellas Pharma plans to supplement the relevant data and reapply for reimbursement.

 

The drug is recommended as Category 1 in the National Comprehensive Cancer Network (NCCN) guidelines.

 

It is a new treatment option for urothelial cancer patients whose cancer has progressed or recurred even after receiving treatment with immunotherapy drugs and platinum-based chemotherapy.

 

The drug was approved in March in Korea for the treatment of patients with locally advanced or metastatic urothelial cancer who have received prior treatment with PD-1 or PD-L1 inhibitors and platinum-based chemotherapy, then was approved in combination with Keytruda in July.

 

Padcev’s efficacy as a monotherapy was demonstrated through the EV-301 study, an open-label, Phase III trial that was conducted on 608 patients with locally advanced or metastatic urothelial cancer who have previously been treated with platinum-based chemotherapy and PD-1 or PD-L1 inhibitors.

 

Study results showed that Padcev reduced the risk of death by 30% compared to chemotherapy.

 

The median overall survival (OS) of the Padcev group was 12.9 months, demonstrating a significant improvement in survival compared to chemotherapy's 9.0 months.

 

In addition, Padcev significantly improved progression-free survival (PFS) with a 38% reduction in disease progression or death risk, with the median progression-free survival (PFS) for Padcev being 5.6 months and 3.7 months for the control group.

 

In the case of the Keytruda-Padcev combination, its efficacy was demonstrated through the randomized Phase III EV-302 trial that was presented at the European Society for Medical Oncology Annual Meeting (ESMO 2023).

 

The trial evaluated Padcev+Keytruda versus conventional chemotherapy in 886 patients in 25 countries.

 

Trial results showed, that at a median follow-up of 17.2 months, the median overall survival in the Padcev combination therapy group was 31.5 months, approximately twice as long as the 16.1 months in the platinum-based chemotherapy group, reducing the risk of death by 53%.