Therapeutic device 'improves OS for lung cancer patients'

Novocure's therapeutic device wins approval in the U.S. …can be used in combination with a conventional immunotherapy

Korean company, Nu Eyne, challenges oncology therapeutic device…aims to enter confirmatory clinical study

The first therapeutic device has been approved for use in non-small cell lung cancer (NSCLC).

 

Novocure's therapeutic device, in combination with an NSCLC medication, demonstrated to improve patients' overall survival and won the approval of the U.S.

 

regulatory authority.

 

In South Korea, Nu Eyne is researching the potential of oncology therapeutic devices through clinical studies.

 

According to industry sources on October 19th, the U.S.

 

Food and Drug Administration (FDA) granted approval for Novocure's Optune Lua for the treatment of metastatic non-small cell lung cancer (NSCLC).

 

Optune Lua is approved for use in combination with PD-1/PD-L1 immunotherapy for cancer or docetaxel.

 

Optune Lua is a device that delivers 'Tumor Treating Fields (TTFields),' which exert physical forces on the electrically charged components of dividing cancer cells, resulting in cell death.

 

Novocure says that TTFields do not affect healthy cells because they have different properties (including division characteristics, morphology, and electrical properties).

 

The basis of approval was the Phase 3 LUNAR study.

 

The clinical trial involved 301 patients with NSCLC who had failed during or after platinum-based chemotherapy.

 

The patients were randomly assigned in a 1:1 ratio to the group receiving Optune Lua plus a PD-1/PD-L1 inhibitor or docetaxel or to the single-treatment group receiving a PD-1/PD-L1 inhibitor or docetaxel.

 

Clinical results showed Optune Lua combination therapy recorded a median overall survival (OS) of 13.2 months, set as the primary endpoint.

 

This was 3 months longer than 9.9 months in the control group.

 

Patients randomly administered Optune Lua plus immunotherapy had a median OS of 19.0 months, and patients administered a PD-1/PD-L1 inhibitor alone had a median OS of 10.8 months.

 

The Optune Lua combination therapy group had an OS extension of over 8 months compared to patients treated with immunotherapy alone.

 

Patients randomly administered Optune Lua plus docetaxel had a median OS of 11.1 months, whereas patients treated with docetaxel had a median OS of 8.9 months.

 

However, this figure did not show a statistically significant difference.

 

Device-related adverse events (AE) occurred in 63.1% of patients treated with Optune Lua combination therapy.

 

Most cases were Grade 1-2 and only 4% (6 patients) experienced Grade 3 skin toxicity and discontinued treatment.

 

Optune Lua did not show Grade 4-5 toxicity, and no deaths occurred.

 

Therapeutic device is being developed in South Korea…Nu Eyne challenges the field

A Korean company, Nu Eyne, has confirmed the effects of immunotherapy and is conducting therapeutic device development.

 

To confirm treatment effects on cancer, Nu Eyne conducted a cell-based clinical study to compare the stimulated group to the non-stimulated group of cultured cells after 48 hours of electrical stimulation.

 

The results showed that the electrically stimulated group had an up to 80% reduction in tumor size.

 

Nu Eyne's technology for its oncology therapeutic device has been developed to deliver a high-intensity electrical field that responds particularly to cancer cells, thereby inducing cell death.

 

The technology is known to have a low risk of causing side effects on surrounding organs.

 

Nu Eyne is developing advanced systems and materials to maximize oncology therapeutic effects.

 

Using its technology, Nu Eyne aims to develop therapeutic devices to secure indications for treating lung cancer and bone metastatic cancer.

 

Nu Eyne aims to complete the development of a clinical therapeutic device prototype in the second half of 2026.

 

After that, the company plans to conduct clinical trials to secure the FDA regulatory approval.