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- The FDA has approved Novocure Ltd's NVCR Investigational Device Exemption (IDE) supplement, reducing the enrollment requirement for its LUNAR Phase 3 trial to 276 patients with 12 months follow-up.
- The trial is testing the effectiveness of Tumor Treating Fields in combination with immune checkpoint inhibitors or docetaxel for patients with stage 4 non-small cell lung cancer (NSCLC) who progressed during or after platinum-based therapy.
- The independent data monitoring committee (DMC) recommended reducing the sample size, which it believes will provide sufficient overall power for both primary and secondary endpoints.
- Novocure remains blinded to all data.
- Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing cancer cells to die.
- Price Action: NVCR shares closed at $175 on Monday.
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