SHANGHAI – Jiangsu Hengrui Medicine Co. Ltd. released positive phase III data for apatinib at American Society of Clinical Oncology (ASCO) meeting last week and is now waiting for the good word from the CFDA for marketing approval in China. Apatinib, a molecular targeted therapy for the treatment of advanced gastric cancer has been shown to be associated with improved survival in patients with prior failure to second line chemotherapy.
The study "may provide new treatment options and lead to new hope for these patients" wrote the principal investigators Jin Li, of Fudan University Cancer Hospital, and Shukui Qin, of the PLA Cancer Center, of Nanjing Bayi Hospital.
Apatinib is a tyrosine kinase inhibitor that targets angiogenesis by blocking new blood vessels that form to feed tumor growth. It inhibits vascular endothelial growth factor receptor-2 (VEGFR2), important for Asian and Chinese patients in particular. Stomach cancer is the second most prevalent cancer after lung cancer, and VEGFR2 is highly expressed in Chinese patients.
While the global incidence of stomach cancer is in decline, China accounts for 40 percent of all new gastric cancer cases in the world where it remains a significant health burden.
Jiangsu Hengrui, of Lianyungang and Shanghai, licensed China rights for apatinib from Advenchen Laboratories LLC, of Moorpark, Calif., and has spent the last 10 years developing it. Rights for the U.S. and Korea are held by LSK Biopartners of Salt Lake City and the Bukwang Pharmaceutical Co., of Seoul, South Korea.
Hengrui, as China's number two oncology company behind Roche, is in a good position to commercialize the drug for the China market, according to Lianshan Zhang, vice president of Jiangsu Hengrui R&D. Hengrui has built capability through developing first to market generics and established its R&D unit after its Shanghai IPO in 2000.
The new drug application for apatinib has been submitted and the company completed a CFDA review panel meeting earlier in the year.
"I am anticipating we should be able to finish the whole process by the third or fourth quarter," said Li Xu of Jiangsu Hengrui's Oncology Business unit, "however until we have formal approval I can not comment further."
The phase III for apatinib was a multicenter, randomized, double-blind, placebo-controlled phase III trial. The trial enrolled 270 patients, 180 on apatinib and 90 on placebo.
The primary outcome was overall survival proven significant compared to the placebo. The overall median survival of the apatinib group was 195 days compared to the placebo group of 140 days with the median progression-free survival being prolonged in the apatinib group, 78 days versus 53 days in the placebo.
Objective response rates were 2.84 percent and 0.00 percent respectively for the apatinib group versus the placebo.
Apatinib, which is taken orally, was stated to be to be well-tolerated with adverse reactions managed by dose interruption and reductions. The recommended dose for apatinib is 850 mg once per day.
The data were presented as ASCO was commented on by Li Jing, of the MD Anderson Cancer Center. According to Xu, comments were favorable though he was asked how the drug would fare in the U.S. if stacked up against ramucirumab (Cyramza, Eli Lilly and Co.), an antibody and potential single agent treatment for advanced gastric cancer.
According to Zhang, the advantage is that apatinib has been tested and proven on Chinese patients with their unique type of stomach cancer.
The apatinib study was selected as "best of ASCO" and will be presented at ASCO China to be held in Guangzhou in July.
"It is an honor to be selected," said Xu. "Out of thousands of abstracts only a few hundred are recognized."
"Apatinib is the first small molecule as a single agent for advanced gastric cancer; that is why it has received so much attention," said Xu.