Seattle Genetics combo shows positive effect in advanced bladder cancer

Seattle Genetics (NASDAQ:SGEN) and collaboration partner Astellas Pharma (OTCPK:ALPMF) announce updated results from an open-label Phase 1b/2 clinical trial evaluating the combination of antibody-drug conjugate (ADC) PADCEV (enfortumab vedotin-ejfv) and Merck’s Keytruda (pembrolizumab) in previously untreated patients with locally advanced or metastatic urothelial cancer who are ineligible for treatment with cisplatin-based chemo. The data will be presented at the ASCO GU Cancers Symposium in San Francisco.

The objective response rate (ORR) was 73.3% (n=33/45) after a median follow-up period of 11.5 months. The complete response rate was 15.6% (n=7/45). Median progression-free survival (PFS) was 12.3 months. Median overall survival (OS) has not been reached.

On the safety front, 57.8% (n=26/45) of participants experienced a serious or life-threatening treatment-related adverse event. The most common were lipase increase (17.7%), rash (13.3%), hyperglycemia (13.3%) and peripheral neuropathy (4.4%). 17.7% (n=8/45) experienced treatment-related immune-mediated adverse events grade serious or higher that required the use of systemic steroids. There were six discontinuations. There was one treatment-related death due to multiple organ dysfunction syndrome.

The FDA approved PADCEV in December 2019 for locally advanced/metastatic urothelial cancer.

https://seekingalpha.com/news/3540411-seattle-genetics-adc-combo-shows-positive-effect-in-advanced-bladder-cancer