Novartis radioligand triumphs in a first-line PhIII trial recruiting patients with rare neuroendocrine tumors

Novartis’ radioligand therapy Lutathera has hit the primary endpoint in a Phase III trial in newly diagnosed patients with a rare form of neuroendocrine tumors, laying the foundation for a potential label expansion to earlier disease.

In the Phase III NETTER-2 trial, Novartis set Lutathera plus standard of care octreotide versus octreotide alone in 222 people with first-line somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

The investigational arm met the progression-free survival (PFS) primary endpoint versus control, and safety findings were consistent with Lutathera’s current label. The label features several boxed warnings, including for myelosuppression and renal toxicity.

Jeff Legos

Novartis said it would present detailed results at a future medical meeting and discuss them with regulatory agencies, with submissions to follow.

“These positive results for Lutathera are quite remarkable and they represent the potential for radioligand therapy to make a meaningful impact for newly diagnosed patients living with advanced GEP-NETs,” said Novartis’ global head of oncology development, Jeff Legos, in a company press release.

Lutathera secured an FDA approval in 2018 in combination with octreotide for inoperable SSTR-positive patients with GEP-NETs who were progressing despite standard treatment.

While NETs are considered an orphan disease, the Swiss drugmaker highlighted that their incidence has grown by more than 500% in the last three decades.

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