Company: ZLAB
Filing Date: 2025-02-27
Form Type: 10-K
Source: 0001628280-25-008409
Chunk: 104

Company: Zai Lab Ltd
Filing Date: 2025-02-27
Form: 10-K
Item: Item 1
Chunk 104
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 to develop and commercialize any TTFields products in Greater China in the field of oncology, and we have commercially launched TTFields in Greater China for certain GBM indications. Significant additional indications for TTFields therapy that we are evaluating include solid tumor types in 2L+ NSCLC and 1L pancreatic cancer. 

•2L+ NSCLC: We participated in the Greater China portion of the Phase III pivotal LUNAR trial, which was intended for patients who had recently been diagnosed with progression of NSCLC during or after platinum-based therapy. The Phase III LUNAR trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in OS for patients with metastatic NSCLC after platinum-based therapies, and a profound OS benefit from TTFields therapy was demonstrated in the ICI subgroup. TTFields therapy was well tolerated with no added systemic toxicities and few grade 3 (and no grade 4 or 5) device-related adverse events. Lung cancer has the highest total incidence of any cancer in mainland China. According to the World Health Organization, the incidence of lung cancer in mainland China in 2022 was around 1.1 million cases. Lung cancer consists of NSCLC in approximately 85% of cases and SCLC in approximately 15% of cases. In October 2024, NovoCure announced that the FDA had approved TTFields therapy, under the brand name OPTUNE LUA, for concurrent use with PD-1/PD-L1 inhibitors or docetaxel, for the treatment of adult patients with metastatic NSCLC who have progressed on or after a platinum-based regimen. We are preparing a similar submission for this indication, with a goal to submit an MAA to the NMPA in the first half of 2025.

•1L Pancreatic Cancer: We participated in the Greater China portion of the Phase III pivotal PANOVA-3 trial evaluating the efficacy of TTFields therapy administered concomitantly with gemcitabine and nab-paclitaxel as a 1L treatment for patients with unresectable, locally advanced pancreatic cancer. In December 2024, we and NovoCure announced that the PANOVA-3 trial met its primary endpoint, demonstrating a statistically significant improvement in mOS versus control group. According to the World Health Organization, pancreatic cancer was the eighth-leading cancer type in China in 2020. There are approximately 134,000 new cases of pancreatic cancer diagnosed each year in China