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Neuroendocrine Tumour Treatment Study pivotal to Registration Process
Oct 14 2021
Following dialogue with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), a bridging study initiated by HUTCHMED (China) being conducted in Japan and involving patients with advanced neuroendocrine tumours (NETs), will support the surufatinib Japanese new drug application (NDA) registration of this treatment for patients by the US Food and Drug Administration (FDA) and the European Medicines Agency (MAA). The first patient was dosed on September 15, 2021.
The basis for the NDA and the MAA includes data from a US Phase I/II study, as well as the completed Phase III SANET-ep and SANET-p studies used to support marketing authorisation in China in advanced NETs, where surufatinib is currently marketed under the brand name SULANDA®.
Part 1 of this two-stage, open label study will assess its safety and tolerability of surufatinib 300mg given once daily, after 28 days of treatment in patients with relapsed/refractory non-hematological malignancies; pharmacokinetics (“PK”) and anti-tumor activity of surufatinib are secondary endpoints. In Part 2 of the study, efficacy will be assessed in patients with locally advanced or metastatic NETs; the primary outcome measure is objective response rate (ORR). The secondary outcome measures include disease control rate (DCR), progression free survival (“PFS”), duration of response (DoR), safety, and PK.
Surufatinib is the third potential new medicine discovered by HUTCHMED to enter into clinical development in Japan. A global Phase III registration study for fruquintinib, known as the FRESCO-2 study, is ongoing in patients with refractory metastatic colorectal cancer. It is expected to enroll over 680 patients from over 150 sites in 14 countries, including Japan. A global single-arm, open-label study, known as the SAVANNAH study, is also ongoing for savolitinib (partnered with AstraZeneca PLC), in combination with TAGRISSO® in non-small cell lung cancer patients whose disease progressed following TAGRISSO due to MET amplification or overexpression.
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