The US Food and Drug Administration (FDA) has granted approval for Novocure’s Optune Lua device to be used in combination with existing treatments for metastatic non-small cell lung cancer (NSCLC).
Designed for adults who have progressed after platinum-based chemotherapy, Optune Lua can be used alongside immune checkpoint inhibitors, such as programmed death receptor-1 (PD-1) and programmed death-ligand 1 (PD-L1) blockers, or the chemotherapy drug docetaxel. This novel device offers a new, continuous treatment option to improve survival outcomes for NSCLC patients.
The new, on-the-go therapy offers patients the ability to treat their cancer continuously while going about daily life, but it is not a stand-alone treatment — it is designed to work alongside other therapies.
Optune Lua uses Tumor Treating Fields (TTFields) technology, which disrupts cancer cell division by applying electric fields that interfere with electrically charged components of cancer cells. This wearable device can be used alongside current treatments to enhance outcomes without systemic toxicity.
TTFields have shown promise across various cancers, including pancreatic and ovarian cancers, demonstrating minimal side effects, mainly limited to mild skin irritation around the application area.
Metastatic NSCLC presents significant challenges, especially when patients no longer respond to platinum-based therapies. With limited treatment options that maintain effectiveness over time, devices like Optune Lua offer a new approach — patients wear the device, receiving portable, non-invasive treatment in combination with their prescribed cancer therapies.
The wearable design of the Optune Lua device is key for patients seeking a more flexible therapy.
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In the Phase III LUNAR study, Optune Lua demonstrated a significant survival benefit. Patients treated with Optune Lua and PD-1/PD-L1 inhibitors saw a median overall survival (OS) of 19 months, compared to 10.8 months for those receiving immunotherapy alone. For those on docetaxel, OS improved to 11.1 months compared to 8.9 months for chemotherapy alone.
The median age of the population was 65 years (ranging from 22 to 86), with 66 percent male and 34 percent female participants. Nearly all patients (96 percent) had an Eastern Cooperative Oncology Group (ECOG) performance status (an indicator of a severely ill patient’s tolerance to therapies) of 0 to 1, meaning they were fully active or restricted only in physically strenuous activity.
Device-related adverse effects were mostly skin irritations, occurring in 63.1 percent of patients. These were generally mild (Grade 1 to 2), and only four percent experienced moderate (Grade 3) skin toxicity requiring treatment breaks. Importantly, no severe (Grade 4 or 5) adverse events were reported.
Optune Lua follows the success of Optune for glioblastoma, expanding TTFields technology to NSCLC. While other devices, such as the TheraBionic P1 — a non-invasive device using low-level radiofrequency electromagnetic fields to target cancer cells — and NanoTherm, a localized hyperthermia treatment approved in Europe for brain tumors that uses magnetic nanoparticles, have made strides in cancer treatment, neither currently offers the portability or broad potential of Optune Lua.
However, the rise of digital health in oncology is not limited to new devices like Optune Lua.
Ongoing clinical trials by the National Cancer Institute (NCI) explore how wearable technologies, mobile apps and machine learning can further enhance cancer care. These studies are investigating ways to monitor patient health remotely, track symptoms in real-time and improve outcomes with digital tools. In addition, Medable’s and Masimo’s recent collaboration aims to integrate wearables into clinical trials, hopefully reducing the burden on cancer patients by enabling remote participation.
With its non-invasive design and proven clinical benefits, the Optune Lua device could not only improve outcomes but also empower patients to maintain their daily routines while undergoing treatment.
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