NovoCure Electrifies NSCLC Space with Pivotal Phase III Win

Lung Cancer Scan

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Thursday, Switzerland-based NovoCure Ltd. announced its Phase III LUNAR trial met its primary endpoint in patients with non-small cell lung cancer (NSCLC).

In the pivotal study, patients subjected to Tumor Treating Fields (TTFields) in conjunction with standard therapies saw a clinically meaningful improvement in overall survival as compared with standard therapies alone.

The combination of TTFields with immune checkpoint inhibitors likewise significantly boosted survival in these patients.

TTFields are electric fields that kill cancer cells by disrupting cell division, interfere with cell migration, suppress cells’ DNA damage response and enhance the immune system’s anti-tumor activity.

By leveraging differences in electrical properties, division rate and morphology, TTFields are able to spare healthy cells, minimizing off-target effects.

With more than 270 stage 4 NSCLC patients enrolled, the pivotal, randomized and open-label LUNAR trial sought to investigate whether TTFields could indeed improve the efficacy of existing cancer therapies.

Aside from anti-cancer activity, the trial also assessed the safety of the electric field intervention. Results showed that TTFields was well-tolerated.

With these data in hand, NovoCure is gearing up for a Premarket Approval application with the FDA later this year. Full results and analyses from LUNAR will be released at a future medical conference, according to the company.

Enhancing a Competitive Therapeutic Space

NovoCure’s electric field-based intervention is designed not as a standalone therapy, but to principally be used with other standard-of-care cancer therapies, such as Merck’s blockbuster Keytruda (pembrolizumab) and Genentech’s Tecentriq (atezolizumab).

However, in the NSCLC space, the array of such drugs is consistently and rapidly growing.

In October, GSK’s own checkpoint inhibitor Jemperli (dostarlimab) aced the Phase II PERLA trial, inducing a favorable objective response rate and progression-free survival in NSCLC patients.

NSCLC therapeutic options also continue to expand beyond immune checkpoint inhibitors. Last month, amid rumors of a possible buyout, California-based Mirati Therapeutics notched an accelerated FDA approval for its KRAS inhibitor adagrasib, now marketed as Krazati.

The regulatory nod allows Krazati to be used in NSCLC patients with locally advanced or metastatic disease, and with the G12C mutation in the KRAS gene.

Nevertheless, NSCLC also sees its fair share of trial flops. In August, for example, Jounce’s vopratelimab, in combination with pimivalimab, fell short of its primary endpoint and could not demonstrate a significantly better mean tumor change than pimivalimab alone.

The same month, Novartis’ canakinumab failed to show superior disease-free survival than placebo in the Phase III CANOPY-A trial.

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