Chi-Med Halts Phase III Study Early After Meeting Primary Endpoint

Hutchison China MediTech Limited, better known as Chi-Med, halted a late-stage study earlyafter an interim analysis showed surufatinib hit the primary endpoint of progression-free survival in advanced non-pancreatic neuroendocrine tumors.

In its announcement this morning, Chi-Med did not disclose the early results of the trial. It only noted that at the interim analysis, surufatinib “met the pre-defined primary endpoint” of PFS and halted the trial.

The Phase III study was being conducted in China. The results will allow Chi-Med to establish a pre-New Drug Application meeting with the China National Medical Products Administration ahead of filing for regulatory approval in that country. London-based Chi-Med added that it intends to submit the results of the Phase III Surufatinib in Advanced Neuroendocrine Tumors – Extra-Pancreatic (SANET-ep) trial to an unnamed upcoming medical conference.

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR). Both receptors inhibit angiogenesis and colony stimulating factor-1 receptor, which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells, the company said.

The SANET-ep trial focused on patients with low- or intermediate-grade advanced extra-pancreatic neuroendocrine tumors who have not received effective treatment in the past from existing medications, such as Pfizer’s Sutent or Novartis’ Afinitor. In the study, patients were randomized at a 2:1 ratio to receive either 300 mg of surufatinib daily or placebo over the course of 28 days. In addition to PFS, secondary trial endpoints included objective response rate, disease control rate, time to response, duration of response, overall survival, safety and tolerability. Chi-Med will release full details of the results at the future conference.

In its announcement, Chi-Med said there were approximately 67,600 newly diagnosed neuroendocrine patients in 2018. The company estimated that there are about 490,000 patients living with the disease in the United States. Neuroendocrine tumors form in cells that interact with the nervous system or in glands that produce hormones. They are typically classified as pancreatic neuroendocrine tumors or other neuroendocrine tumors. Neuroendocrine tumors are associated with a relatively long duration of survival compared to other tumors.

In addition to neuroendocrine tumors, Chi-Med is also studying the safety and efficacy of surufatinib in other cancers. In March, the company initiated a Phase IIb/III study comparing surufatinib with capecitabine (sold as Xeloda in the U.S.) in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The first patient was dosed on March 22 in China.

https://www.biospace.com/article/chi-med-halts-phase-iii-study-early-after-interim-results-show-pfs-goal-was-met/