Multinational phase 1b study of gedatolisib in combination with other antitumor agents for advanced solid tumors

Gedatolisib, also known as PF-05212384, is a PI3K/mTOR inhibitor. A multinational phase 1b trial evaluated gedatolisib in combination with other agents for advanced solid tumors. In the expansion phase patients with triple-negative breast cancer received gedatolisib plus cisplatin. The objective response rate was 40% (95% CI 12,2-73,8) among first-line patients and 33.3% (9.9-56.1) among second/third-line patients, There was one patient with complete response in both groups. The authors conclude that gedatolisib combination therapy had an acceptable tolerability profile, with clinical activity at the recommended phase 2 dose in patients with TNBC.