FDA Fast Tracks Investigational Drug for Potential Approval in Lung Cancer Subtype

Treatment with an investigational drug elicited a median progression-free survival (time from treatment until disease progression or death) of 8.9 months among patients with a form of unresectable or metastatic squamous non-small cell lung cancer, according to trial findings.

The Food and Drug Administration (FDA) granted the investigational drug sapanisertib a fast track designation to treat adults with unresectable or metastatic squamous non-small cell lung cancer whose tumors have a mutation in nuclear factor erythroid 2-related factor (NRF2).

A fast track designation is given by the FDA to a drug that has the potential to treat a serious condition and fill an unmet medical need. In giving the designation, the FDA may expedite the review of the drug for approval and frequently communicate with the manufacturer.

“While 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, the CEO of sapanisertib’s manufacturer Calithera Biosciences, said in a press release announcing the FDA fast track designation.

NRF2 mutations, according to sapanisertib’s manufacturer, occur in approximately 15% of patients with unresectable or metastatic squamous non-small cell lung cancer. The way the investigational drug works is that it targets a survival mechanism found in the specific mutated tumor cells.

Findings from a recent clinical trial demonstrated that treatment with sapanisertib alone elicited a response in three of the 11 patients enrolled onto the trial. Moreover, the data showed that the investigational drug induced a median progression-free survival (time from treatment until disease progression or death) of 8.9 months among patients with this form of unresectable or metastatic squamous non-small cell lung cancer.

Investigators are currently conducting a multi-center study evaluating the efficacy and safety of sapanisertib in patients with NRF2-mutated squamous non-small cell lung cancer whose disease has worsened on or after platinum-doublet chemotherapy and immune checkpoint inhibitor therapy with or without an anti-CTLA-4 treatment.

According to a filing on ClinicalTrials.gov, the investigators plan to enroll approximately 50 patients to receive treatment with the investigational drug sapanisertib. It is estimated that the trial will be completed no later than 2025.

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