- Zai Lab Limited ZLAB and Novocure Ltd NVCR 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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