Drugs

Novocure Scraps TTFields Study for Real-World Data

Novocure has terminated its LUNAR-4 study, a Phase 2 open-label trial testing Tumor Treating Fields (TTFields) together with Merck’s Keytruda (pembrolizumab) in metastatic non-small cell lung cancer (NSCLC) patients previously treated with a PD-1/PD-L1 inhibitor and platinum chemotherapy. The company notified trial sites and said the decision was driven by the availability of real-world evidence that can meet the study’s objectives, not by safety concerns.

LUNAR-4 had been designed to evaluate TTFields delivered by the NovoTTF-200T device alongside pembrolizumab in the post-platinum, post-immunotherapy setting. The listing on ClinicalTrials.gov describes the study as multinational and single-arm.

The move comes after Novocure’s larger phase 3 LUNAR trial — conducted in a similar post-platinum population — showed a statistically significant overall-survival benefit when TTFields was added to standard therapies, including immune checkpoint inhibitors (ICIs). In the ICI subgroup, median overall survival reached 18.5 months with TTFields plus ICI versus 10.8 months with ICI alone, according to the company.

Data from the Phase 3 LUNAR study supported FDA’s 10/2024 approval of Novocure’s Optune Lua (TTFields) for concurrent use with a PD-1/PD-L1 inhibitor or docetaxel in adults with metastatic NSCLC who progressed on or after platinum therapy (see earlier story). The approval created a post-approval setting from which real-world outcomes can now be drawn, the company says.

TTFields, described as low-intensity, alternating electric fields that disrupt cancer cell division, were previously approved for glioblastoma and malignant pleural mesothelioma. The NSCLC indication expanded the technology’s use in solid tumors, the company says.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome