FDA grants fast track designation to sapanisertib for lung cancer subset
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The FDA granted fast track designation to sapanisertib for treatment of certain patients with non-small cell lung cancer.
The designation applies to use of the agent for adults with unresectable or metastatic squamous NSCLC whose tumors harbor nuclear factor erythroid 2-related factor (NRF2) mutations and who have received prior immune checkpoint inhibitor therapy and platinum-based chemotherapy.
Sapanisertib (CB-228, Calithera Biosciences) is an investigational mammalian target of rapamycin complex (mTORC) 1/2 inhibitor.
Approximately 15% of patients with squamous NSCLC harbor NRF2 mutations.
“[Although] there have been significant advances in targeted treatments for lung cancer, little progress has been made specifically for patients with squamous lung cancer,” Susan Molineaux, PhD, CEO of Calithera, said in the release. “In addition, we know that patients with lung cancers that harbor mutations in the NRF2/KEAP1 pathway typically have poorer outcomes than those whose tumors do not have these mutations.“
A phase 2 trial showed sapanisertib induced confirmed responses in three of 11 (27%) heavily pretreated patients with NRF2-mutated squamous NSCLC, with median PFS of 8.9 months (95% CI, 7 to not reached). The agent also appeared well-tolerated, according to a Calithera Biosciences-issued press release.
An ongoing multicenter, open-label phase 2 trial is evaluating sapanisertib for patients with squamous NSCLC whose disease progressed on or after platinum-doublet chemotherapy and anti-PD-1/PD-L1 therapy, with or without anti-CTLA-4 therapy. The trial is designed to confirm the activity of sapanisertib among patients with NRF2-mutated tumors vs. those with NRF2 wild-type tumors. Investigator-assessed overall response rate and safety will serve as primary endpoints. Secondary endpoints include duration of response, PFS and OS.
Data from this trial are expected by the first quarter of 2023.
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