Zai Lab Limited and Novocure have released an update on their phase 3 pivotal LUNAR trial of Tumor Treating Fields (TTFields) in the fourth stage non-small cell lung cancer (NSCLC).
FREMONT, CA: Zai Lab Limited and Novocure have released an update on their phase 3 pivotal LUNAR trial of Tumor Treating Fields (TTFields) in the fourth stage non-small cell lung cancer (NSCLC) after platinum failure. Following a regular evaluation of the study by an independent data monitoring committee (DMC), Novocure was notified that the pre-specified interim analysis for the LUNAR trial would be accelerated given the length of accrual and the number of events observed to date. The interim study looked at data from 210 patients who had enrolled in the LUNAR trial throughout February 2021. The DMC decided to continue the LUNAR trial after reviewing the interim analysis study and finding no signs of increased systemic toxicity.
The DMC also noted that continuing accrual to 534 patients with an 18-month follow-up for patients randomized to the control arm is likely unnecessary and probably unethical. The DMC suggested a smaller sample size of 276 patients with a 12-month follow-up period, believing that this would provide adequate overall power for primary and secondary endpoints. The DMC suggested no other changes to the trial's design.
The significant endpoint of the LUNAR trial is that patients treated with TTFields plus immune checkpoint inhibitors or docetaxel have a better overall survival rate than those treated with immune checkpoint inhibitors or docetaxel alone. In addition, overall survival in the immune checkpoint inhibitor and docetaxel treatment subgroups will be examined in the final analysis.
"We are very pleased with the DMC recommendations, which we believe support the potential for TTFields to make a significant difference in treatment outcomes for patients with non-small cell lung cancer, whether used together with immune checkpoint inhibitors or docetaxel," said William Doyle, Novocures Executive Chairman. "The accelerated interim analysis with an encouraging outcome adds to the accumulating evidence of Tumor Treating Fields broad potential across a range of hard-to-treat cancers."
"Combination therapy is a cornerstone of cancer care, and we believe using TTFields together with other cancer treatments, including immunotherapies, may lead to better outcomes for some patients," continued Mr. Doyle. "We are very encouraged that, consistent with our expectations, the DMC concluded that TTFields exhibited no systemic toxicity. We will continue to develop TTFields as a limited toxicity backbone therapy upon which other standard-of-care and emerging cancer treatments can be added."