ZLAB - Novocure Zai Lab post Phase 3 data for electric fields device in lung cancer

2023-06-06 09:02:06 ET

NovoCure ( NASDAQ: NVCR ) lost ~10% while Zai Lab Limited ( ZLAB ) shed ~1% in the premarket Tuesday after the companies shared late-stage data for their cancer treatment device, Tumor Treating Fields (TTFields), in patients with lung cancer.

Ahead of a presentation at the ongoing Annual Meeting of the American Society of Clinical Oncology (ASCO), NovoCure ( NVCR ) and Zai Lab ( ZLAB ) said TTFields therapy reached the primary endpoint in a trial named LUNAR.

The Phase 3 study was designed to evaluate TTFields plus immune checkpoint inhibitors (ICI) or chemotherapy docetaxel (experimental arm) against ICI or docetaxel alone (control arm) in patients with non-small cell lung cancer (NSCLC).

The trial reached the primary goal of overall survival, indicating a statistically significant and clinically meaningful improvement of three months in median overall survival (OS) for TTFields plus standard therapies.

In the ICI subgroup, patients on TTFields plus physician’s choice ICI indicated a median overall survival of 18.5 months compared to 10.8 months in patients treated with ICIs alone (n=68; HR=0.63; P=0.03).

One-year survival rates stood at 53% for those treated with TTFields therapy together with standard treatments and 42% for patients in the control arm.

TTFields therapy, already approved in the U.S. to treat glioblastoma and mesothelioma, was well tolerated in the study leading to a “few grade 3 (no grade 4 or 5) device-related adverse events,” the company said.

Results are yet to undergo peer review, which typically precedes publication in a medical journal. NovoCure ( NVCR ) and Zai Lab ( ZLAB ) expect to submit LUNAR data to the FDA in H2 2023 seeking a Premarket Approval (PMA) for TTFields.

For further details see: