Tumor-treating electric fields show early promise in NSCLC — boosting both Novocure and its Chinese biotech partner
More than a decade after the FDA first approved electric fields as a treatment for glioblastoma, Novocure said it’s seen a promising signal that they could also work against non-small cell lung cancer.
After reviewing data at an interim analysis, Novocure said, the independent data monitoring committee suggested downsizing and shortening the Phase III trial — from 18-month followup on 534 patients to 12-month followup on 276 patients. Following the original trial protocol is “likely unnecessary and possibly unethical,” the DMC told the company; given what they have seen, a smaller trial with shorter followup should provide sufficient statistical power for both the primary endpoint in overall survival and secondary endpoints.
Data from 210 patients were included for the analysis.
“Pending regulatory approval, the recommended protocol adjustments could accelerate trial completion by more than a year,” CEO Asaf Danziger said in a statement. The LUNAR trial is originally scheduled to wrap in 2023.
Investors were pleased, bidding shares $NVCR up 53.55% to $202.5.
The early signs of efficacy could also bode well for Zai Lab, which has licensed China rights to all applications of the device, according to Jefferies analyst Michael Yee. Lung cancer prevalence in China is 3 times as high as that in the US, and the positive data — when they arrive — could give Samantha Du’s team added leverage in reimbursement negotiations, he noted. Zai Lab’s stock on Nasdaq $ZLAB shot up 13.83% to $150.31.
Already cleared for brain cancer (under the brand name Optune) and a rare type of cancer in the lung and chest called malignant pleural mesothelioma, the treatment is in other trials for brain metastases, gastric cancer, liver cancer, pancreatic cancer and ovarian cancer.
With a frequency range between 100 to 500 kHz, tumor treating fields (or TT fields) are designed to specifically penetrate the cancer cell membrane and stop their division.
Novocure has previously shown that recurrent GBM patients who underwent TT fields treatment saw improvement in survival comparable to that of a second round of chemotherapy — minus the side effects like pain, nausea, fatigue or diarrhea.
In the NSCLC lung cancer trial, which is dubbed LUNAR and focuses on stage 4 patients, investigators wanted to tease out the effect of TT fields when added to checkpoint inhibitors or the chemo agent docetaxel.
“Combination therapy is a cornerstone of cancer care,” executive chairman William Doyle said, “and we believe using TTFields together with other cancer treatments, including immunotherapies, may lead to better outcomes for some patients.”
Whereas GBM patients would wear an electric patch on their heads, the NSCLC application involves wearing “four electrically insulated electrode arrays on the chest” while carrying on their regular daily lives.