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In the SANET trials, a Chinese anti-angiogenic pill slowed both gut and pancreatic neuroendocrine tumours, but its US application was refused.
SANET-ep and SANET-p, led by trial NCT02588170 and sponsored by Hutchmed, showed in 2020 that the Chinese anti-angiogenic tablet surufatinib slows both extra-pancreatic and pancreatic neuroendocrine tumours, but its US application was refused. The two trials randomised 198 patients with extra-pancreatic and 172 with pancreatic progressive tumours to surufatinib or placebo in China, and both met their primary progression-free survival endpoints with large effects, leading to approval in China in 2020 and 2021, while the FDA issued a complete response letter in 2022 requiring a multiregional trial. OnCo links them to neuroendocrine tumours, anti-angiogenic therapy and VEGF and VEGFR as targets. Whether a single-country trial can ever support a US approval is the wider question the refusal raised.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
369 enrolled.
Shares Surufatinib, Hutchmed.
Shares Hutchmed, VEGF / VEGFR, Anti-angiogenic therapy.
Shares VEGF / VEGFR, Anti-angiogenic therapy.
Shares VEGF / VEGFR, Anti-angiogenic therapy.
Shares Hutchmed, VEGF / VEGFR, Anti-angiogenic therapy.
Shares Hutchmed, Anti-angiogenic therapy.
Shares VEGF / VEGFR, Anti-angiogenic therapy.
Shares VEGF / VEGFR, Anti-angiogenic therapy.