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Novartis casts a broader Netter for Lutathera

Novartis’s SSTR2-targeting radioconjugate Lutathera already has a broad US label for SSTR-positive gastroenteropancreatic neuroendocrine tumours, but this isn’t stopping the company from starting another phase 3 in early-line disease. Netter-3, recently listed on clinicaltrials.gov, will test Lutathera plus Sandostatin, versus Sandostatin alone, in around 240 patients with first-line grade 1 and 2 GEP-NETs and a high disease burden. Grade 1 GEP-NETs are the least advanced type, and are said to be slow growing. The new trial could take Lutathera into even earlier territory than Netter-2, which tested the same combo in first-line patients with grade 2 and 3 disease. Positive Netter-2 data were presented at last year’s ASCO-GI meeting; the trial formed the basis of a 2024 EU filing in first-line disease, and Novartis previously said it would also be important to convince US doctors of the merits of earlier use. The group seems likely to be following a similar strategy with Netter-3. Still, Novartis hopes that Lutathera, which made $600m in 2023, might have utility beyond GEP-NETs: a phase 3 in small-cell lung cancer is slated for 2027, the Swiss company said at the recent JP Morgan healthcare conference.

 

Expanding the Netter: selected studies of Novartis’s Lutathera

TrialSettingNote
Netter-12nd-line GEP-NETsPFS NR with Lutathera + Sandostatin, vs 8.5mth with Sandostatin; approved with broad label in Jan 2018
Netter-21st-line GEP-NETs, grade 2 & 3PFS 22.8mth with Lutathera + Sandostatin, vs 8.5mth for Sandostatin; awaiting EU approval decision
Netter-31st-line GEP-NETs, grade 1 & 2To begin May 2025

Source: OncologyPipeline & clinicaltrials.gov.

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