Novocure’s lung cancer moonshot comes good

Nearly two years ago Novocure telegraphed that a hit in the pivotal trial of its anticancer device was likely, and so it has come to pass. The Lunar study had been on course to enrol more than 500 patients with advanced platinum-resistant non-small cell lung cancer, to be treated either with Novocure’s NovoTTF-200T device, which emits Tumour Treating Fields – an electrical field-based therapy to shrink tumours – plus checkpoint inhibitors or docetaxel, with the drugs alone as the control. After an interim analysis in 2021 pointed to high efficacy the trial was cut to just 276 patients. Now final data have shown a significant and meaningful improvement in overall survival for the device versus control, the company said. Full data will be presented at an upcoming conference, and Novocure plans to file for US and EU approvals in the second half. Full data are necessary to gauge chances of approval; it might be that efficacy is driven by baseline imbalances or an effect in checkpoint-naive patients, and of course chemo is no longer a first-line NSCLC standard. Nods for two similar Novocure devices suggest that safety will be clean, and a chunk of the NSCLC market could be up for grabs. Novocure’s shares climbed 57% this morning.

Novocure's products and pipeline
Device Status
Optune 
(NovoTTF-200A)
Approved in the US for glioblastoma Apr 2011
Optune Lua 
(NovoTTF-100L)
Approved in the US for mesothelioma May 2019
NovoTTF-200T Pivotal Lunar trial in advanced NSCLC hit Jan 2023
Pivotal Panova-3 trial in locally advanced pancreatic cancer to report 2024
Pilot Keynote-B36 trial + Keytruda in untreated NSCLC to report 2024
NovoTTF-200O Pivotal Engot-ov50/Innovate-3 trial in recurrent ovarian cancer to report late 2023
NovoTTF-200M Pivotal Metis trial in newly diagnosed brain metastases from NSCLC to report 2024
Source: Evaluate Medtech & company website.

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