With its electrical field-emitting Optune device, Novocure has achieved something biotech has repeatedly failed to do: improve the survival of glioblastoma patients. A different version of the device, Optune Lua, is also approved for mesothelioma. Efforts to extend into other cancers, however, have hit a snag, with the company yesterday admitting that several clinical trial readouts would be delayed by Covid-19. Most important of these is Panova-3, the pivotal trial of Optune in pancreatic cancer, whose readout has been pushed back a year. The 14% fall in Novocure’s share price yesterday, though, was also to do with the glioblastoma indication. Medicare coverage for the use of Optune to treat the brain cancer had initially been denied; a reversal of this decision in 2019 has allowed Novocure to appeal previously denied claims, creating a backlog of payments and swelling the group’s top and bottom lines. This backlog has now been pretty much exhausted, so many analysts expect Novocure’s sales to grow much more slowly in the coming years. R&D expenses are also taking their toll, with the company sponsoring an astonishing 34 active clinical trials, 26 of which are in brain tumours.
Selected upcoming Optune trial readouts | |||
---|---|---|---|
Trial | Details | N | Readout |
Hepanova | Pilot ph2 in advanced liver cancer | 25 | Final data Q2 2021 (delayed from Q1) |
Innovate-3 | Pivotal ph3 in recurrent ovarian cancer | 540 | Interim data Q3 2021; final data 2023 |
Lunar | Pivotal ph3 in NSCLC | 534 | Interim data Q4 2021; final data 2023 |
EF-31 | Pilot ph2 in gastric cancer | 28 | Final data 2022 (delayed from 2021) |
Metis | Pivotal ph3 in brain mets from lung cancer | 270 | Final data 2022 |
EF-33 | Pilot ph2 of high-intensity arrays in recurrent glioblastoma | 25 | Final data 2022 |
Panova-3 | Pivotal ph3 in pancreatic cancer | 556 | Interim data 2022 (delayed from 2021); final data 2023 |
Source: EvaluateMedTech & company release. https://www.evaluate.com/vantage/articles/news/snippets/novocure-finds-timing-inopportune-optune |
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