China-based Zai Lab Ltd (ZLAB) (NASDAQ: ZLAB; HKG: 9688) and its partner Novocure Ltd (NASDAQ: NVCR) have presented positive results from the Phase III LUNAR clinical trial at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. The trial evaluated the use of Tumor Treating Fields (TTFields) therapy in combination with standard therapies for the treatment of non-small cell lung cancer (NSCLC). Despite achieving the primary endpoint of significant overall survival benefit, Novocure’s stock plummeted by 43% due to analysts’ concerns over the study design and secondary endpoint.
LUNAR Study Design and Outcomes
The Phase III LUNAR study tested the safety and effectiveness of TTFields therapy when used in conjunction with an immune checkpoint inhibitor (ICI) or docetaxel (experimental arm) compared to ICI or docetaxel alone (control arm) for second-line patients with metastatic NSCLC who progressed during or after chemotherapy. The study met its primary endpoint, showing a statistically significant and clinically meaningful 3-month improvement in median overall survival (OS) using TTFields plus standard therapies (13.2 months vs. 9.9 months, P=0.035). TTFields was well tolerated, with no increased systemic toxicity and a limited number of level 3 adverse events.
Plans for Regulatory Submissions
Novocure intends to use the LUNAR data as the basis for a Premarket Approval (PMA) submission to the US in the second half of 2023. Zai Lab, which contributed to the China portion of the LUNAR study, plans to submit a Marketing Authorization Application (MAA) to China’s National Medical Products Administration (NMPA) following Novocure’s submission to the FDA.
Market Reaction and Analyst Concerns
Despite the improvement in OS, Novocure’s share price dropped significantly after the announcement, as analysts questioned the trial design, which focused on patients initially treated with chemotherapy rather than an ICI, despite ICI treatment now being the standard first-line NSCLC care. Additionally, the secondary endpoint of progression-free survival (PFS) was not achieved, with 4.8 months for TTFields versus 4.1 months for the control. At the time of writing, Zai’s Hong Kong stock price also declined by over 15% during the trading day.-Fineline Info & Tech
