Dive Brief:
- The Food and Drug Administration on Tuesday approved a new device to treat non-small cell lung cancer, Novocure’s Optune Lua, which creates electric fields that its manufacturer says disrupts malignant cell division. The FDA cleared the device for use with immunotherapy or chemotherapy in people whose cancer has spread and progressed following chemo.
- Approval was based on results from “Lunar,” a Phase 3 trial in which people who used the device with standard therapies had a 26% reduced risk of death over a median follow up of around 10 months. The results were controversial, however, because the trial included concurrent care with immunotherapies, which are typically used as a first-line treatment, as well as chemo.
- The OK should boost Novocure’s revenue, which lagged behind its expenditures by $207 million in 2023 and $72 million through the first six months of 2024. Novocure shares rose 22% from Tuesday afternoon to Wednesday’s market open, before settling down to trade up around 5% by mid-morning.
Dive Insight:
Novocure’s device first won FDA approval in 2011 in glioblastoma, a rapid and usually deadly type of brain cancer, and then scored another nod in 2019 for the lung cancer mesothelioma. The company calls its approach “tumor treating fields,” or TTFs, a technology that aims to impair tumor growth by disrupting electrical charges in the proteins of dividing cancer cells.
In the Lunar trial, Novocure enrolled 276 patients whose cancer progressed after first-line platinum-based chemo. Patients were then randomized to receive either the TTF device along with standard therapy — which included chemo or “PD-1” drugs like Merck & Co.’s Keytruda — or those standard therapies alone.
Trial volunteers who received the TTF lived a median of 13.2 months from enrollment, while those who were just given drug therapy lived a median of 9.9 months, a difference that was statistically significant.
However, those positive results have received some scrutiny. Jonathan Chang, an analyst at the investment firm Leerink Partners, has noted how the Lunar trial focused on second-line treatment, where chemo is the standard of care for this type of cancer. PD-1 drugs, meanwhile, are typically used in the first-line setting. Therefore, Optune Lua should have only been studied in combination with chemo, not immunotherapy, to match how these patients would be treated in real practice.
Chang further highlighted how, in the trial volunteers who received Optune Lua and chemo, the difference in overall survival compared to those on chemo alone was 2.4 months, which wasn’t statistically significant. Additionally, a high number of trial participants had an unknown PD-1 status — a factor that could have affected results.
Optune Lua’s effectiveness alongside current medical practice could become clearer with readouts from two other trials in lung cancer: Lunar-2, in first-line treatment with a PD-1 and chemo, and Lunar-4, in second-line treatment with a PD-1 following disease progression on a PD-1 alone. Those studies are scheduled to conclude in 2028 and 2026, respectively.
The lung cancer approval, even with modest uptake in a large market, could add meaningful revenue to Novocure’s business, Chang wrote in a October note. The company recorded $509 million worth of revenue last year.