0
0
COLOGNE, GERMANY – A combination therapy of enfortumab vedotin and pembrolizumab offers significant hope for patients battling advanced bladder cancer, particularly those unable to receive standard cisplatin-based chemotherapy, according to a recent assessment by Germany’s Institute for Quality and Efficiency in Health Care (IQWiG).
The assessment, evaluating the drugs for first-line treatment of unresectable or metastatic urothelial carcinoma (the most common type of bladder cancer), found a “major added benefit” regarding overall survival for patients unsuitable for cisplatin. This marks the first time IQWiG has awarded its highest benefit rating in this therapeutic area.
Urothelial carcinoma affects the lining of the urinary tract, most commonly the bladder. While enfortumab vedotin alone received approval in April 2022 for pretreated patients, its combination with the immunotherapy drug pembrolizumab was approved in September 2024 as an initial treatment for advanced cases.
IQWiG’s rigorous review compared the combination therapy against the current standard chemotherapy treatments (cisplatin plus gemcitabine or carboplatin plus gemcitabine). The analysis drew data from an ongoing clinical trial initiated in March 2020.
A key finding highlighted a clear survival advantage for the enfortumab vedotin plus pembrolizumab group, especially pronounced in the subgroup of patients considered cisplatin-ineligible. The Institute determined this significant advantage would likely hold even accounting for complexities in the trial design.
The study began before avelumab maintenance therapy became standard practice following chemotherapy (approved in the US in June 2020 and Europe in January 2021). While the trial didn’t incorporate avelumab into its protocol, the manufacturer adapted the design to allow for its use where available and provided sensitivity analyses to account for its absence in some participants. IQWiG found these analyses sufficient to confirm the robust survival benefit of the new combination therapy.
“For the first time, we have awarded a major added benefit to a drug combination in this therapeutic indication,” stated Katrin Nink, Head of the Oncology Division (solid tumors) at IQWiG’s Drug Assessment Department. “The main decisive factor is the survival advantage for bladder cancer patients for whom cisplatin-based therapy is not an option.”
For patients who are eligible for cisplatin-based therapy, IQWiG also identified an added benefit from the combination treatment, although it deemed this benefit “not quantifiable” based on the current data. The assessment also noted advantages in morbidity outcomes and quality of life, alongside some specific side effect differences compared to standard chemotherapy.
This dossier assessment is a crucial step within Germany’s formal process for evaluating new medicines (AMNOG). Following this report, the Federal Joint Committee (G-BA) will conduct a commenting procedure before making a final determination on the extent of the added benefit, which influences reimbursement decisions.
Disclaimer: This news article is based on information released by the Institute for Quality and Efficiency in Health Care (IQWiG) regarding their benefit assessment of enfortumab vedotin in combination with pembrolizumab. It is intended for informational purposes only and should not be considered medical advice. Treatment decisions should always be made in consultation with qualified healthcare professionals based on an individual’s specific medical condition and history.
