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
Event | Setting | Status | Note |
---|---|---|---|
Ph3 Metis readout | NSCLC brain mets (post-SRS) | Reported Mar 2024 | Met primary but not secondary endpoints |
FDA approval decision | 2L NSCLC (post-chemo) | Due H2 2024 | Questions about setting’s relevance (used primarily after chemo, while most 1L pts currently receive CPIs) |
Ph3 Panova-3 readout | + gemcitabine + Abraxane in 1L pancreatic cancer | Due Q4 2024 | Interim analysis in Jul 2023; recommended trial continue |
Ph3 Trident readout | + radiation + Temodar in 1L glioblastoma | Due 2026 | FDA 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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