Novocure gets FDA nod for lung cancer electric field device

The Food and Drug Administration has given the green light to a new device designed to treat non-small cell lung cancer. This device, known as the Optune Lua by Novocure, generates electric fields that the manufacturer claims disrupt the division of malignant cells. The FDA has approved its use in conjunction with immunotherapy or chemotherapy for patients whose cancer has metastasized and continued to progress after initial chemotherapy.

The approval is based on data from the Lunar trial, a Phase 3 study that demonstrated a 26% reduction in the risk of death for patients who used the device with standard therapies. The median follow-up period for this study was around 10 months. Despite this seemingly positive outcome, the results have stirred some controversy because the trial included the use of immunotherapies, which are generally administered as a first-line treatment, alongside chemotherapy.

Novocure is expected to see a financial boost from this approval. The company had previously reported a shortfall of $207 million in 2023 and $72 million in the first half of 2024. Following the announcement, Novocure's shares rose by 22% but later stabilized to a 5% increase.

Novocure’s device initially received FDA approval in 2011 for treating glioblastoma, an aggressive type of brain cancer. It was later approved in 2019 for lung cancer mesothelioma. The company refers to its technology as tumor treating fields (TTFs), which aim to inhibit tumor growth by disrupting the electrical charges within the proteins of dividing cancer cells.

In the Lunar trial, 276 participants whose cancer had progressed after first-line platinum-based chemotherapy were enrolled. These patients were then randomized to receive either the TTF device combined with standard therapy—which included chemotherapy or PD-1 inhibitors like Merck's Keytruda—or standard therapy alone.

The study found that patients who received the TTF device had a median survival of 13.2 months from enrollment, compared to 9.9 months for those who received only drug therapy. This difference was statistically significant. However, the results have been met with some skepticism. Jonathan Chang, an analyst at Leerink Partners, pointed out that the Lunar trial focused on second-line treatment where chemotherapy is the standard care for this cancer type. PD-1 inhibitors, on the other hand, are usually first-line treatments. Therefore, the trial should have only combined the TTF device with chemotherapy to reflect real-world clinical practice.

Chang also noted that among trial participants who received both Optune Lua and chemotherapy, the survival difference compared to those on chemotherapy alone was only 2.4 months, which was not statistically significant. Additionally, a significant number of trial participants had an unknown PD-1 status, which could have influenced the study outcomes.

Further clarity on Optune Lua’s effectiveness in current medical settings may come from two other ongoing trials: Lunar-2, investigating first-line treatment with a PD-1 inhibitor and chemotherapy, and Lunar-4, evaluating second-line treatment with a PD-1 inhibitor following disease progression on a PD-1 inhibitor alone. These studies are expected to conclude in 2028 and 2026, respectively.

Despite the controversy, the approval could be financially beneficial for Novocure. Even a modest market uptake could add significant revenue to the company, which reported $509 million in revenue last year.