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Novocure’s Lunar eclipse

Novocure has had some success with its tumour treating fields (TTFields) technology recently, but the company just quietly terminated a phase 2 trial in second-line NSCLC. The study, Lunar-4, enrolled patients who had previously received a PD-(L)1 inhibitor and chemo, so might have been intended to answer questions about Novocure’s pivotal Lunar study. Lunar supported FDA approval last October in second-line NSCLC, but its design was criticised for, among other things, the fact that most patients in the study had received chemo – and not checkpoint inhibitors – first line. Novocure disclosed the Lunar-4 discontinuation in an SEC filing, saying it planned to use real-world evidence instead – a move that will disappoint fans of more rigorous studies. But Novocure has more pressing matters; namely, an approval decision in pancreatic cancer, a filing in NSCLC brain metastases, and two 2026 readouts, with a new first-line glioblastoma combo, and in metastatic pancreatic cancer. TTFields was first approved in recurrent glioblastoma in 2011; approvals then came in first-line glioblastoma, in 2015, and mesothelioma, in 2019, before the potentially more lucrative NSCLC nod. Products based on the tech sold $605m in 2024, but revenues have been sequentially flat in the first couple of quarters of 2025.

 

Key trials of Novocure’s TTFields

TrialSettingRegimenNote
Ph3 LunarPost-platinum NSCLC+ checkpoint inhibitors or docetaxel, vs checkpoint inhibitors or docetaxelFDA approved Oct 2024
Ph3 Panova-31st-line pancreatic cancer+ gemcitabine + Abraxane, vs gemcitabine + AbraxaneData at ASCO 2025: OS 16.2mth vs 14.2mths; filed with FDA Aug 2025, decision due H2 2026
Ph3 MetisBrain mets from NSCLC+ supportive care, vs supportive careData at ASCO 2024: hit primary endpoint, time to intracranial progression, but not secondary OS endpoint; filing due H2 2025 (from “early 2025”)
Ph3 Trident1st-line glioblastoma+ radiation + Temodar; vs radiation + TemodarData due H1 2026
Ph2 Panova-41st-line metastatic pancreatic cancer+ Tecentriq, gemcitabine + Abraxane (uncontrolled)Data due H1 2026
Ph2 Lunar-4Post-PD-(L)1 + chemo NSCLC+ Keytruda (uncontrolled)Terminated Aug 2025; Novocure hopes to use real-world evidence instead

Source: OncologyPipeline & clinicaltrials.gov.

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