Novartis Launches Phase III Trial of SSTR2-Targeted Radiopharmaceutical Lutathera in China for Advanced GEP-NET

On June 10, Novartis in drugClinical Trial and Information Disclosure Platform registered aEvaluation[177Lu]Lu-DOTA-TATE（Lutetium [177Lu]-Octreotide，Lutathera）InStage 1 and Stage 2 AdvancedGastroenteropancreatic Neuroendocrine Tumors（GEP-NET）Phase III Study of Efficacy and Safety in Patients（NETTER-3）。

Source: DrugClinical Trial and Information Disclosure Platform

NETTER-3 is aItemPhase III, International Multicenter, Randomized, Open-label Study, AimedInNewly Diagnosed with Somatostatin Receptor Positivity（SSTR+）, Well-differentiated Grade 1 and Grade 2(G1 and G2) (Ki-67<10%)Advanced GEP-NET with High Disease Burden(For examples of high disease burden, see Section 5.1)In patients, evaluate the efficacy and safety of [177Lu]Lu-DOTA-TATE + octreotide LAR compared to octreotide LAR alone.

The study plans to enroll240 subjects,Among them, 28 in China. The primary endpoint isProgression-Free Survival(PFS), secondary endpoints includeTime to deterioration,Objective Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DOR), etc.

Lutetium [177Lu]-OxodotreotidePeptide is a targetedThe RDC of SSTR was approved for use in the United States as early as 2018.Gastroenteropancreatic Neuroendocrine Tumors. Since its launch, the product's sales have continued to grow, generating revenue in 2024.$7.24 billion。

Source: Insight Database

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