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Novocure’s brain mets win comes with caveats

Novocure’s stock climbed 12% yesterday after the group toplined a win with its tumour treating fields (TTFields) technology in the phase 3 Metis trial in NSCLC brain metastases. However, a closer look shows reasons to be cautious. Patients in the open-label study were treated with stereotactic radiosurgery followed by TTFields plus best supportive care, or best supportive care alone. Novocure and its China partner Zai Lab said the trial met its primary endpoint, time to intracranial progression, which was 21.9 months and 11.3 months in the treatment and control arms respectively. However, Metis did not hit secondary endpoints including overall survival and radiological response rate. Still, Novocure, which has a market cap of $1.6bn, has bigger fish to fry: TTFields, already marketed for glioblastoma and mesothelioma, is due an FDA approval decision this year in the larger use of second-line NSCLC. Although the group’s pivotal trial here, Lunar, succeeded last year, there were questions about its design given that most patients in the study received chemo first line, rather than the current standard of care, PD-(L)1 inhibitors. Even if the therapy gets the nod in NSCLC, it is unclear how well it will sell. 

 

Key upcoming events for Novocure’s TTFields

EventSettingStatusNote
Ph3 Metis readoutNSCLC brain mets (post-SRS)Reported Mar 2024Met primary but not secondary endpoints
FDA approval decision2L NSCLC (post-chemo)Due H2 2024Questions about setting’s relevance (used primarily after chemo, while most 1L pts currently receive CPIs)
Ph3 Panova-3 readout+ gemcitabine + Abraxane in 1L pancreatic cancerDue Q4 2024Interim analysis in Jul 2023; recommended trial continue
Ph3 Trident readout+ radiation + Temodar in 1L glioblastomaDue 2026FDA approved for 1L glioblastoma + Temodar in 2015; and 2L glioblastoma in 2011

CPI=checkpoint inhibitor; SRS=stereotactic radiosurgery. Source: OncologyPipeline, company presentation Feb 2024.

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