Clinical Trials Arena

Novartis eyes first-line status for its radionucleotide therapy Lutathera

The Phase III trial of Luthathera and long-acting octreotide combination as a first-line therapy showed improved progression-free survival in treating GEP-NETs.

Novartis has announced that the Phase III NETTER-2 trial of the combination therapy of Lutathera (lutetium Lu 177 dotatate) and a long-acting octreotide met its primary endpoint.

Lutathera is a peptide receptor radionuclide therapy that uses high-dose radiation to target and destroy cancer cells. It was first approved by the US Food and Drug Administration (FDA) as a combination therapy with a long-acting octreotide for treating somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in 2018.

Novartis also plans to discuss the new NETTER-2 trial results with regulatory bodies.

NETs are rare tumours that develop in the cells of the neuroendocrine system, which are present throughout the body. Half of the NET tumours start in the gastrointestinal system and can be either benign or neoplastic, as per Cancer Research UK. The standard treatment for NETs is either surgical management or somatostatin analogues (SSAs) therapy.

GlobalData forecasts the NET market to grow to $3.42bn in 2030 across eight major markets.

Novartis is expected to control up to half of the market with its extensive portfolio, including SSA therapy Sandostatin (octreotide).

GlobalData is the parent company of Clinical Trials Arena.

Both of Novartis’s NET therapies were top 20 high-grossing drugs for the company, with Sandostatin and Lutathera generating $660m and $299m in H2 2023, as per the company’s Q2 financials.

The open-label Phase III NETTER-2 trial (NCT03972488) showed that the first-line treatment of Lutathera and a long-acting octreotide significantly improved progression-free survival in patients with GEP-NET. Detailed data from the trial is planned for presentation at an upcoming medical meeting.

The study population included GEP-NET patients who were either newly diagnosed or had high proliferation rate tumours (Grade 2 and 3). Patients who either never received SSAs or received SSAs but showed no disease progression.

Other radionucleotide therapies in Novartis’ catalogue include Pluvicto (lutetium Lu 177 vipivotide tetraxetan), approved for the treatment of PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).