Background
Interim analysis of the phase 3 LUNAR trial led to a recommendation to reduce the number of lung cancer patients required.
This recommendation is based on the strongly positive data gathered so far from the current patient population treated with tumor-treating fields.
About Tumor Treating Fields
Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division.
When cancer develops, rapid and uncontrolled division of unhealthy cells occurs. Electrically charged proteins within the cell are critical for cell division, making the rapidly dividing cancer cells vulnerable to electrical interference.
As healthy cells differ from cancer cells in their division rate, geometry and electric properties, the frequency of TTFields can be tuned to specifically affect the cancer cells while leaving healthy cells mostly unaffected.
Use of Tumor Treating Fields for the treatment of NSCLC is investigational only.
About the Study in Lung Cancer
This is a phase 3 LUNAR trial (NCT02973789) in patients with stage IV Non–Small Cell Lung Cancer, NSCLC, after progression on or after platinum-base chemotherapy.
The interim analysis included data taken from 210 patients with a data monitoring committee recommendation to reduce the sample size from 534 patients to approximately 276 patients.
It is possibly unethical given the available data.
The TTFields were given concurrent with Immunotherapies, such as Keytruda, Opdivo and others or the chemotherapy Taxotere.
Treatment in the TTFields arm of the current trial requires that patients wear 4 electrically insulated electrode arrays on the chest and that they maintain regular daily routine with the therapy.
Side Effects
There was no evidence of increased systemic toxicity when patients were treated with TTFields.
Conclusion
When a treatment works, the path for approval gets shortened. These are groundbreaking news to stage 4, metastatic, Non-Small Cell Lung Cancer patients.
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