Japan-based Astellas Pharma Inc. (TYO: 4503) has announced marketing clearance by China’s National Medical Products Administration (NMPA) for its Padcev (enfortumab vedotin) in combination with Keytruda (pembrolizumab) to treat adult patients with locally advanced or metastatic urothelial cancer (la/mUC). This combination offers a new therapeutic option to patients in China, providing an alternative to the standard of care, which has been platinum-containing chemotherapy for nearly 40 years.
Clinical Trial Results
The NMPA’s decision was based on results from the Phase III EV-302 study. The treatment combination achieved a median overall survival (OS) of 31.5 months (95% CI: 25.4-NR), compared to 16.1 months (95% CI: 13.9-18.3) with platinum-containing chemotherapy, representing a 53% reduction in the risk of death (P<0.00001). Additionally, a median progression-free survival (PFS) of 12.5 months (95% CI: 10.4-16.6) was reported with the treatment combination, compared to 6.3 months (95% CI: 6.2-6.5) with platinum-containing chemotherapy, representing a 55% reduction in the risk of cancer progression or death (P<0.00001). The safety results were consistent with those previously reported, and no new safety issues were identified.
Drug Profiles
Padcev is a first-in-class antibody-drug conjugate (ADC) directed against Nectin-4, a protein highly expressed in bladder cancer cells. It was first approved in China in August of last year for the treatment of la/mUC after prior treatment with platinum-containing chemotherapy and programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors. Keytruda, on the other hand, has received multiple indication approvals in China since 2018, including for melanoma, non-small cell lung cancer, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, colorectal cancer, hepatocellular carcinoma, triple negative breast cancer, MSI-H/dMMR solid tumors, gastric cancer, and bile duct cancer.
Significance of the Clearance
The marketing clearance by the NMPA for the combination of Padcev and Keytruda highlights the potential of this therapy to improve outcomes for patients with urothelial cancer. This development underscores Astellas Pharma’s commitment to advancing innovative treatments and providing new options for patients in need.-Fineline Info & Tech
