Zai Lab's pivotal LUNAR study for non-small cell lung cancer achieved overall survival as the primary endpoint

• Full data from the LUNAR study will be presented at a future medical congress

Zai Lab Inc. and Novocure today announced that the LUNAR study met its primary endpoint, demonstrating a statistically significant and clinically significant improvement in overall survival compared to standard therapy alone. The LUNAR study is a pivotal, open-label, randomized study to evaluate the safety and efficacy of electric tumor field therapy (TTFields) in combination with standard therapy for stage 4 non-small cell lung cancer (NSCLC) that progresses during or after platinum-based therapy.

The LUNAR study also showed statistically significant and clinically significant improvements in overall survival in patients treated with TTFields plus immune checkpoint inhibitors (ICIs) compared with those treated with immune checkpoint inhibitors alone. Patients treated with TTField plus docetaxel showed a positive trend in overall survival compared with those treated with docetaxel alone. The number of patient enrollments was balanced between the ICI and docetaxel cohorts in the experimental and control groups, and the control group performed consistently with previous findings. Patients enrolled in the experimental group of this study were well tolerated by tumor electric field therapy.

William Doyle, Executive Chairman of Novocur:

We are pleased with the positive results of the LUNAR study. Prior to LUNAR, the last Phase 3 clinical study to significantly improve overall survival in patients with advanced platinum-resistant non-small cell lung cancer was six years ago, highlighting the difficulty of treating the disease. We are pleased with the excellent performance of TTField combined with immunotherapy, which is expected to further prolong patient survival and achieve breakthroughs." I would like to thank our patients and researchers for their courage and dedication in completing the LUNAR study. And, I want to thank the Novocure staff for their tireless commitment to patients and their perseverance in driving Novocure to this important milestone.

Dr. Ying Du, Founder, Chairman and CEO of Zai Lab, said:

We are excited about the promise of TTField to address the unmet medical needs of lung cancer patients worldwide. Lung cancer is the most common cancer in China, with about 700,000 new cases of non-small cell lung cancer each year. We are very excited to contribute to LUNAR research." This collaboration is another example of how we can benefit our patients together."

Novocure plans to present the full results of the LUNAR study at a future medical conference. Novocure expects to submit a premarket approval application to the U.S. Food and Drug Administration (FDA) in the second half of 2023. Novocure also expects to apply for CE marking in the European Union at the same time as it submits its application to the FDA.