FORMAL STUDY discussant Matthew I. Milowsky, MD, of the University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, said there had been few drug approvals in advanced bladder cancer until 5 new checkpoint inhibitors were approved over the past 2 years. “Although these agents are effective, they do not benefit the majority of patients,” he stated. “We need new agents for this new post–checkpoint inhibitor space.”

Matthew I. Milowsky, MD

“Sacituzumab govitecan is an exciting new agent,” Dr. Milowsky explained. “The objective response rate and the duration of response are promising in this difficult-to-treat group of patients.”

“The toxicities of this agent are not inconsequential,” he continued. “Neutropenia and diarrhea are manageable but need to be considered.”

“We have to look at these results in the context of other new agents in this space, including erdafitinib, enfortumab vedotin, and ramucirumab plus docetaxel. Responses are observed with all these agents, even in patients with liver metastases. In small studies, these agents have had an impressive response rate, progression-free survival, and overall survival compared with docetaxel,” Dr. Milowsky told listeners.

Clinical Implications

“IT WILL BE important how we make decisions once these drugs become available. We need to select the right drug for the right patient. This requires looking at biomarkers, toxicity profile, and pharmacokinetics to deliver the right amount to the patient,” continued Dr. Milowsky.

“The toxicity profiles suggest that sacituzumab may not be a good option for patients with significant gastrointestinal disorders or those at high risk for febrile neutropenia. We make these decisions every day for patients in the clinic,” he said. ■

DISCLOSURE: Dr. Milowsky is a consultant/advisor for BioClin Therapeutics; has received institutional research funding from Acerta Pharma, Astellas Pharma, Bristol-Myers Squibb, Incyte, Merck, Pfizer, Roche/Genentech, Clovis, Inovio Pharmaceuticals, AstraZeneca, X4 Pharmaceuticals, and Seattle Genetics; has received travel and other expenses from Roche/Genentech; and other relationships with Asieris.