Novocure gets a new field
Novocure has added another use for its tumour treating fields (TTFields) technology, announcing an FDA nod after hours on Wednesday in first-line pancreatic cancer. The decision was based on the Panova-3 trial, which found a median overall survival of 16.2 months with the device plus gemcitabine and Abraxane, versus 14.2 months with the drugs alone. The group is also facing an FDA verdict this year in NSCLC brain metastases, and that could be more controversial; here, the Metis study hit its primary endpoint of time to intracranial progression, but missed on secondary endpoints including OS. Readouts are also due this year in first-line glioblastoma, from the phase 3 Trident study, and from the phase 2 Panova-4 trial, evaluating a Tecentriq combo in first-line pancreatic cancer. TTFields was first approved in recurrent glioblastoma in 2011, then in first-line glioblastoma in 2015, and mesothelioma in 2019. A potentially more lucrative nod in second-line NSCLC followed in 2024, based on the Lunar trial, which was criticised for, among other things, the fact that most patients in the study had received first-line chemo – and not checkpoint inhibitors. Novocure’s stock climbed 26% premarket on Thursday.
Key trials of Novocure’s TTFields
| Trial | Setting | Regimen | Note |
|---|---|---|---|
| Ph3 Lunar | Post-platinum NSCLC | + checkpoint inhibitors or docetaxel, vs checkpoint inhibitors or docetaxel | FDA approved Oct 2024 (as Optune Lua) |
| Ph3 Panova-3 | 1st-line pancreatic cancer | + gemcitabine + Abraxane, vs gemcitabine + Abraxane | FDA approved Feb 2026 (as Optune Pax) |
| Ph3 Metis | Brain mets from NSCLC | + supportive care, vs supportive care | Filed with FDA Dec 2025; decision due Q4 2026 |
| Ph3 Trident | 1st-line glioblastoma | + radiation + Temodar; vs radiation + Temodar | Data due Q2 2026 |
| Ph2 Panova-4 | 1st-line metastatic pancreatic cancer | + Tecentriq + gemcitabine + Abraxane (uncontrolled) | Data due Q1 2026 |
| Ph3 Lunar-2 | 1st-line NSCLC | + Keytruda + chemo, vs Keytruda + chemo | Completes Oct 2028 |
| Ph3 Keynote-D58 | 1st-line glioblastoma | + Keytruda + chemo, vs TTFields + chemo | Enrolment to complete Q4 2026 |
| Ph2 Lunar-4 | Post-PD-(L)1 + chemo NSCLC | + Keytruda (uncontrolled) | Terminated Aug 2025 |
| Ph3 Innovate-3 | Platinum-resistant ovarian cancer | + paclitaxel, vs paclitaxel | Failed Aug 2023 |
Source: OncologyPipeline.
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