Gilead’s antibody drug conjugate (ADC) Trodelvy has received an accelerated approval from the US Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic urothelial cancer (UC), the most common form of bladder cancer. The approval covers the use of Trodelvy (sacituzumab govitecan-hziy) in patients with advanced UC who have previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. Trodelvy was approved on the basis of results from Gilead’s Phase II TROPHY study, which evaluated the drug as monotherapy or as a combination therapy in patients with metastatic UC after progression on a platinum-based chemotherapy and PD-1/L1 inhibitor. In 112 patients who were evaluable for efficacy, 27.7% of those who were treated with Trodelvy responded to treatment, with 5.4% experiencing a complete response and 22.3% experiencing a partial response. The study also found a median duration of response of 7.2 months for those treated ...
Keytruda is now allowed only for the patients whose tumor expression levels of the biomarker PD-L1 meet a combined positive score of 10 or higher. Tecentriq can only be used where PD-L1 immune cells can cover only 5% or more of their tumor area.
The annual meeting of the American Urological Association had Sesen Bio present its three-month data for its bladder cancer treatment Vicinium. This was Sesen Bio’s first readout following its name change from Eleven Biotherapeutics.
TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that it has entered into a clinical collaboration with Genentech, a member of the Roche Group, to evaluate the combination of the PD-L1 antibody atezolizumab (TECENTRIQ®) and TESARO’s PARP-inhibitor ZEJULA® (niraparib) in patients with metastatic bladder cancer.
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