FDA Approves Wearable TTFields Treatment for Patients With Metastatic NSCLC

The US Food and Drug Administration (FDA) has approved Optune Lua, a wearable treatment that delivers Tumor Treating Fields (TTFields) for concurrent use with PD-1/PD-L1 inhibitors or docetaxel, according to an announcement from Novocure. The approval is for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) who have progressed on or after a platinum-based regimen.

Optune Lua, which is the “first treatment of its kind for metastatic NSCLC” is a portable device that produces alternating electric fields known as TTFields and delivers them through non-invasive, wearable arrays. TTFields “exert physical forces on the electrically charged components of dividing cancer cells, resulting in cell death,” officials explained in the announcement.

“Novocure is committed to extending survival in some of the most aggressive and difficult-to-treat cancers. The approval of Optune Lua brings a new and urgently needed option for people with metastatic NSCLC who have progressed while on or after platinum-based chemotherapy,” Novocure CEO Asaf Danziger said in a statement. “We are grateful to the patients, caregivers, investigators and healthcare providers who supported the clinical trials that led to this approval.”

The device was evaluated in the pivotal phase 3 LUNAR trial, a prospective, randomized, open-label, multicenter study that compared the use of Optune Lua concurrent with PD-1/PD-L1 inhibitors (n=145) or docetaxel to PD-1/PD-L1 inhibitors or docetaxel alone (n=146) for patients with metastatic NSCLC who progressed during or after platinum-based therapy.

The LUNAR trial met its primary endpoint by “demonstrating a statistically significant and clinically meaningful” extension of median overall survival (OS) by 3.3 months in patients who received concurrent treatment with Optune Lua and a PD-1/PD-L1 inhibitor or docetaxel (P=0.04).

The median OS was 13.2 months (95% CI, 10.3 to 15.5 months) in patients who received the concurrent treatment with Optune Lua and a PD-1/PD-L1 inhibitor or docetaxel compared to a median OS of 9.9 months (95% CI, 8.2 to 12.2 months) in those who received a PD-1/PD-L1 inhibitor or docetaxel.

Ticiana Leal, MD, Associate Professor and Director of the Thoracic Oncology Program at the Winship Cancer Institute of Emory University School of Medicine, Atlanta, Georgia, and primary investigator of the LUNAR study, weighed in on the significance of the approval.

“There have been a number of important advances in first-line treatment for NSCLC, but this is an aggressive disease, and most patients will develop progression, with limited effective treatment options in second line and beyond,” Dr. Leal said in a statement. “The overall survival results we observed with Optune Lua in the LUNAR study mark the first substantial improvement in more than 8 years in this patient population which, when combined with Optune Lua’s lack of systemic toxicity, make this a compelling development for many patients and their physicians who need better treatment options for this advanced disease.”

Device-related adverse events (AEs) occurred in 63.1% of patients (n=89). The AEs were skin-related disorders under the transducer arrays and the “majority of these events were low grade” AEs of grade 1 or 2, with only 4% (n=6) experiencing grade 3 skin toxicity requiring a break from treatment, officials said in the announcement. There were no grade 4 or grade 5 toxicities related to Optune Lua and no device-related AEs that caused death.

GO2 for Lung Cancer Chief Patient Officer Danielle Hicks also shared her thoughts on the approval in a statement. “We are excited patients with metastatic NSCLC have more options, which they urgently need,” Hicks said. “The fight against lung cancer is always evolving, and the number of people affected by this disease is underappreciated. That is why Novocure’s commitment to advancing treatment is exciting for the whole lung cancer community.”

Source: Novocure