HQ Team
September 3, 2024: Merck & Co., got approval from the European Commission to market its combination therapy to treat metastatic urothelial cancer or bladder cancer in 27 member states and other nations.
The EU decision comes after the European Society for Medical Oncology and European Association of Urology clinical guidelines recommended the combination as the preferred first-line treatment for these patients, regardless of platinum chemotherapy eligibility., according to a statement.
The drug, Keytruda or pembrolizumab, is an anti-PD-1 therapy or a type of immunotherapy that modulates immune response at the tumour site, used in combination with antibody conjugate Padcev or enfortumab vedotin-ejfv, for treating unresectable or metastatic urothelial carcinoma in adults.
End-stage trial data
The EC gave a positive recommendation from the Committee for Medicinal Products for Human Use received in July 2024, which was based on results from the first interim analysis of the end-stage trials conducted in a research collaboration with Pfizer and Astellas.
Data from the trial showed the combination therapy had “statistically significant and clinically meaningful improvements” in overall survival and progression-free survival compared to platinum-based chemotherapy — gemcitabine plus cisplatin or carboplatin.
Urothelial carcinoma, also called transitional cell carcinoma, is a cancer that starts in the urothelial cells which line which line the urethra, bladder, ureters, renal pelvis, and some other organs.
Primary cancer is where cancer starts, for example, primary bladder cancer. The cancer cells can break away from the primary cancer and settle and grow in another part of the body. This new cancer growth is called secondary cancer. Secondary cancers are also called metastases. Unresectable cancers are inoperable.
Cut in risk of death
At a median follow-up of 17.3 months Keytruda in combination with enfortumab vedotin reduced the risk of death by 53% compared to platinum-based chemotherapy. It reduced the risk of disease progression or death by 55%.
The combination, to be marketed in all 27 European Union member states will also include European Economic Area members Iceland, Liechtenstein, Norway and Northern Ireland.
In December 2023, KEYTRUDA in combination with enfortumab vedotin was approved in the U.S. for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
Merck, in collaboration with Pfizer and Astellas, is evaluating this combination as part of an extensive clinical development program in multiple stages of urothelial cancer, including two Phase 3 clinical trials in muscle-invasive bladder cancer, according to the statement.
