Novartis Phase 3 Study of Radioligand Therapy Meets Primary Endpoint in Rare Neuroendocrine Cancer

Rare Daily Staff

Novartis said its radioligand therapy Lutathera met its primary endpoint in a phase 3 trial as a first line treatment in a rare neuroendocrine cancer.

First line treatment with Lutathera in combination with long-acting octreotide demonstrated a significant improvement in progression-free survival (PFS) in patients with newly diagnosed somatostatin receptor (SSTR)-positive, Grade 2 and 3, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) versus high-dose long-acting octreotide alone. The phase 3 NETTER-2 trial also met the key secondary endpoint of objective response rate (ORR). No new or unexpected safety findings were observed in the study and data are consistent with the already well-established safety profile of Lutathera.

NETs are a type of cancer that originate in neuroendocrine cells throughout the body and are commonly considered slow-growing malignancies. However, some NETs are associated with rapid progression and poor prognosis and in many cases, diagnosis is delayed until patients have advanced disease. Even though NETs are a rare disease, their incidence has grown more than 500 percent in the last three decades and there is an urgent need for additional treatment options for patients newly diagnosed with inoperable or advanced disease.

With these results, NETTER-2 is Lutathera’s second phase 3 trial showing clinically meaningful results for patients. The approval of Lutathera was originally based on the pivotal NETTER-1 trial, which demonstrated highly significant and clinically meaningful PFS prolongation for patients treated with Lutathera in combination with long-acting octreotide versus high-dose (60 mg) long-acting octreotide for SSTR-positive, inoperable midgut neuroendocrine tumors (NETs) who were progressing despite standard treatment.

“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 Jeff Legos, executive vice president, Global Head of Oncology Development at Novartis. “Exploring the use of radioligand therapies in earlier lines of treatment for patients with cancer is part of our larger, collaborative effort to precisely deliver novel treatment modalities directly to the cancer cells to improve patient outcomes.”

The findings from NETTER-2 will be presented at an upcoming medical meeting and discussed with regulatory authorities.

Novartis believes that by harnessing the power of radioactive atoms and applying it to advanced cancers, radioligand therapy is theoretically able to deliver radiation to target cells anywhere in the body.

Lutathera is an Advanced Accelerator Applications radioligand therapy (RLT) approved in the United States for the treatment of SSTR-positive GEP-NETs, including foregut, midgut, and hindgut neuroendocrine tumors in adults and in Europe for unresectable or metastatic, progressive, well-differentiated (G1 and G2), SSTR-positive GEP-NETs in adults.

Photo: Jeff Legos, executive vice president, Global Head of Oncology Development at Novartis