After reviewing interim results from 210 patients participating in a phase 3 study, an independent monitoring committee is recommending changes to Novocure's (NVCR 5.47%) non-small cell lung cancer (NSCLC) trial. Specifically, the committee is suggesting that the number of patients enrolled in the study be reduced to 276 patients from 534 patients and the patient follow-up period be shortened to 12 months from 18 months.
The committee said it's "likely unnecessary and possibly unethical for patients randomized to the control arm to continue accrual" to the prior enrollment target and timeline.
The trial is evaluating the impact of Novocure's tumor-treating fields, or TTFs, on overall survival rates. TTFs are specially tuned frequencies that can disrupt cancer cell division and multiplication in patients via a specially designed vest and external device. The primary endpoint of the study is determining if adding TTFs to checkpoint inhibitors or docetaxel -- two commonly used NSCLC treatments -- improves outcomes.
Although Novocure remains blind to the interim results from this trial, the independent-monitors' guidance suggests the data is compelling. If so, then TTFs could eventually reshape patient treatment. There are nearly 200,000 new cases of NSCLC diagnosed in the U.S. annually and unfortunately, the five-year survival rate across all lung cancers is only 20.5%, according to the National Cancer Institute.