Zai Lab LimitedZLAB and Novocure LtdNVCR announced that the LUNAR study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in overall survival over standard therapies alone.
The LUNAR study evaluated the safety and efficacy of Tumor Treating Fields (TTFields) together with standard therapies for stage 4 non-small cell lung cancer (NSCLC) following progression while on or after treatment with platinum-based therapy.
The LUNAR study also showed a statistically significant and clinically meaningful improvement in overall survival when patients were treated with TTFields, and immune checkpoint inhibitors compared to those treated with immune checkpoint inhibitors alone.
The data also exhibited a positive trend in overall survival when patients were treated with TTFields and docetaxel versus docetaxel alone.
TTFields therapy was well tolerated.
Novocure expects to file a Premarket Approval application with the 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.
Price Action: NVCR shares are up 52% at $107.23, and ZLAB shares are up 45.96% at $49.32 during the premarket session on the last check Thursday.
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