Fast Track for Calithera Bio Lung Cancer Drug

FDA has granted Calithera Biosciences a fast track designation for mTORC 1/2 inhibitor sapanisertib (CB-228) for treating adult patients with unresectable or metastatic squamous non-small cell lung cancer (sqNSCLC) whose tumors have a mutation in nuclear factor erythroid 2-related factor (NFE2L2, also called NRF2) and who have received prior platinum-based chemotherapy and immune checkpoint inhibitor therapy.

“NRF2 mutations are found across multiple solid tumor types, with these mutations occurring in approximately 15% of sqNSCLC patients,” the company says. “Sapanisertib targets a key survival mechanism in NRF2-mutated tumor cells.” In a recent investigator-initiated Phase 2 trial, the company says the drug demonstrated durable single-agent activity with a 27% confirmed overall response rate and median progression free survival of 8.9 months in heavily pretreated patients with NRF2-mutated sqNSCLC.