Zai Lab Limited and Novocure have announced the LUNAR study met its primary endpoint. It demonstrates statistically significant and clinically meaningful improvement in overall survival. LUNAR is a pivotal study to test the safety and effectiveness of Tumor Treating Fields (TTFields) along with standard therapies for stage 4 non-small cell lung cancer. This study has showed a statistically significant and clinically meaningful improvement among patients treated with TTFields and Immune Checkpoint Inhibitors in comparison with those treated with ICI alone. It showed positive overall survival when patients were treated with both TTFields and docetaxel as compared to docetaxel alone.
William Doyle, Novocure’s Executive Chairman said, We are pleased with the positive readout of the LUNAR study. Prior to LUNAR, the last phase 3 trial to lead to significant improvement in overall survival in late-stage, platinum-resistant non-small cell lung cancer was six years ago, underlining the difficulty in treating this disease.” “We are also pleased by the profound performance of the TTFields together with immunotherapy, which has the potential to meaningfully extend patient survival beyond what was previously possible,” he added.
NSCLC accounts for about 85% of all lung cancer and about 193000 patients are diagnosed with NSCLC each year in the U.S. It has been observed that approximately 46000 patients receive second-line treatment for stage 4 non-small cell lung cancer each year in the U.S. The primary endpoint is superior overall survival of patients with TTFields and immune checkpoint inhibitors or docetaxel versus immune checkpoint inhibitors or docetaxel alone.
Novocure plans to release the full results of the LUNAR study in the future medical conference. It expects to file a Premarket Approval application with U.S. FDA in 2023.
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