Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that a Phase III trial for its radioligand therapy (RLT) Lutathera (lutetium (177Lu) oxodotreotide) combined with the symptom-control drug octreotide has successfully met its primary endpoint of progression-free survival (PFS) in patients with SSTR-positive, aggressive, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This achievement marks a significant advancement in the treatment of this rare disease.
Trial Results and Clinical Impact
The trial results demonstrated that the combination of Lutathera and octreotide prolonged PFS compared to high-dose octreotide alone, offering a new treatment option for patients with GEP-NETs. The safety data from the trial was consistent with Lutathera’s well-established profile, providing confidence in the therapy’s tolerability and side effect management.
Building on Previous Success
These positive results expand on a previous study that showed the clinical benefit of RLT paired with octreotide in SSTR-positive, refractory, inoperable midgut NETs. The initial trial provided the evidence necessary for the first global approvals of Lutathera, setting a foundation for its use in treating GEP-NETs.
Regulatory Discussions and Production Expansion
With the new data in hand, Novartis plans to engage in discussions with regulatory authorities to potentially expand the therapy’s indications and accessibility. Concurrently, the company is working to expand its global RLT production capacity to meet the growing demand for Lutathera, ensuring that more patients can benefit from this innovative treatment.-Fineline Info & Tech
