Innovative Therapeutics in Oncology and Neuroscience
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Tumor Treating Fields
Late-stage
Pivotal LUNAR Study in Non-Small Cell Lung Cancer Met Primary Overall Survival Endpoint
Primary
Data Summary of LUNAR study (N=276)
LUNAR
Phase 3 Trial of TTFields with Standard of Care for
Metastatic Non-Small Cell Lung Cancer
Key Secondary
•
OS with TTFields +
SOC
OS in ICI-treated
subgroup
vs SOC alone
•
OS in docetaxel-treated
subgroup
TTFields + SOC provided a statistically significant and clinically
meaningful 3-month improvement in mOS vs SOC
➤ Statistically significant ~8-month increase in mOS with
TTFields an ICI (from 10.8 to 18.5 months)
There was a 2.4-month difference in mOS with TTFields +
docetaxel (from 8.7 to 11.1 months)
No added systemic toxicities
Next Steps and Core Opportunity
Next Steps
•
Core Opportunity
Lung cancer is the most common cancer type
•
FDA accepted for filing the Premarket Approval (PMA) application in
January 2024 for treatment of 2L+ NSCLC
in China, with ~740K new NSCLC cases¹
diagnosed each year
.
Zai Lab plans to submit Marketing Authorization Application (MAA) to
the NMPA for this indication in 2024, following the U.S. submission
•
Initiative on reimbursement for innovative
medical devices - first access planned at
provincial level2
Note: (1) Changfa Xia, et al. Cancer statistics in China and United States, 2022: profiles, trends, and determinants; (2) In May 2023, NHSA published an announcement collecting opinions on making related polices regarding the medical insurance
listing for consumables at the provincial level.
Clinical Data -
OncologyView entire presentation