Pfizer/Astellas’ Enfortumab Vedotin-Pembrolizumab Combination Receives CDE Acceptance for New Indication in China

On March 27, 2024, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China accepted a supplemental Biologics License Application (sBLA) for enfortumab vedotin in combination with pembrolizumab (Keytruda) for the first-line treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who have not received prior treatment. If approved,Enfortumab vedotin in combination with pembrolizumab has the potential to change the existing treatment paradigm and become the first combination therapy to replace platinum-based chemotherapy, which is currently the standard first-line treatment for la/mUC.

Urothelial carcinoma (UC) includes cancers of the lower urinary tract (bladder and urethra) and upper urinary tract (ureter and renal pelvis), with lower urinary tract cancers accounting for 90% to 95% of all urothelial carcinoma cases. Globally, there are approximately 614,000 new cases of bladder cancer each year, and about 220,000 patients die from the disease. [iii] It is estimated that in 2022, approximately 93,000 patients in China were diagnosed with bladder cancer, and about 41,000 patients died.

The sBLA for the combination therapy used as a first-line treatment is based on the results of the Phase 3 clinical trial EV-302 (also known as KEYNOTE-A39). The study found that the combination therapy improved overall survival (OS) and progression-free survival (PFS) in previously untreated patients with locally advanced or metastatic urothelial carcinoma (la/mUC), with results showing statistical significance and clinical meaningfulness. Safety outcomes were consistent with previously reported results for the combination therapy, with no new safety concerns identified.

The NMPA is also reviewing enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who have previously received PD-1/L1 inhibitors and platinum-based chemotherapy.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and Japan's Ministry of Health, Labour and Welfare (MHLW) are also reviewing the combination therapy of enfortumab vedotin and pembrolizumab. The U.S. Food and Drug Administration (FDA) approved this combination therapy in December 2023.

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