Patient mortality risk reduced! Jiangsu Hengrui Pharmaceuticals (600276.SH) releases latest clinical data on Iletikan liposomes.

On November 6, Jiangsu Hengrui Pharmaceuticals (600276.SH) announced that a randomized, double-blind, parallel-controlled, multi-center Phase 3 clinical study of Irinotecan liposomes () combined with 5-FU/LV as second-line treatment for locally advanced or metastatic pancreatic cancer after treatment failure with gemcitabine has been published in the journal "Nature" sub-journal "Signal Transduction and Targeted Therapy". The study results show that compared to the control group, the risk of death for pancreatic cancer patients was reduced by 37% with the Irinotecan liposomes () combination therapy. According to publicly available information from Jiangsu Hengrui Pharmaceuticals, the company has utilized liposome technology to encapsulate Irinotecan into the phospholipid bilayer, developing a new formulation that can passively target tumors - Irinotecan Hydrochloride Liposomes (). The design of the liposome formulation helps protect Irinotecan from early conversion into the active metabolite SN-38, allowing Irinotecan to remain in circulation longer, increase drug deposition and contact within the tumor, and enhance its inhibitory effect on tumor growth. In terms of primary research endpoints, the Irinotecan liposomes () group had a median OS extension of 2.4 months compared to the placebo group (7.39 months vs. 4.99 months), with a 37% reduction in the risk of death. In terms of secondary research endpoints, the Irinotecan liposomes () group significantly extended the PFS period by 2.73 months compared to the placebo group (4.21 months vs. 1.48 months), with a 64% reduction in the risk of disease progression or death. The safety profile was good. Based on this Phase 3 clinical study, Irinotecan liposomes () were approved by the Chinese NMPA for marketing in December 2023, in combination with 5-FU and LV, for the treatment of unresectable locally advanced or metastatic pancreatic cancer patients who have failed chemotherapy based on gemcitabine.