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Re: KIPK post# 182

Tuesday, 01/10/2023 8:27:30 AM

Tuesday, January 10, 2023 8:27:30 AM

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“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,” said William Doyle, Novocure’s Executive Chairman. “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. I would like to thank our patients and investigators for their courage and dedication in completing LUNAR. And, I would like to thank Novocure’s employees for their unrelenting commitment to patients and their perseverance in propelling Novocure to this major milestone.”

“We are excited about the potential of TTFields to address the unmet medical needs of lung cancer patients around the world. In China, lung cancer is the most common cancer type with approximately 700,000 new NSCLC cases diagnosed each year,” said Dr. Samantha Du, Founder, Chairperson, and CEO of Zai Lab. “We are pleased to contribute and be a part of the LUNAR study and this partnership is yet another great example of how collaboration benefits everyone.”

Novocure plans to release the full results of the LUNAR study at a future medical conference. Novocure expects to file a Premarket Approval application with the U.S. Food and Drug Administration (FDA) in the second half of 2023. Novocure also expects to file for a CE Mark in the European Union concurrently with the FDA submission.

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