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Novartis details first-line data for radiopharma drug Lutathera

A radiopharmaceutical drug from Novartis kept a rare type of neuroendocrine cancer at bay for longer than did standard therapy, according to detailed clinical trial results unveiled by the Swiss drugmaker on Friday. 

Adding the drug, sold by Novartis as Lutathera, to a high-dose hormonal therapy called octreotide cut the risk of disease progression or death by 72% over octreotide alone, the company said. The data are from a Phase 3 trial of people who had not previously received treatment for their gastroenteropancreatic neuroendocrine tumors, which are referred to as GEP-NETs for short. 

Novartis previously said the trial had succeeded in September, but did not disclose detailed data on the drug’s benefit. The full findings were presented at the American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium. 

“These findings should instill confidence among physicians in using Lutathera as a first-line treatment for patients with this life-threatening type of cancer,” said Simron Singh, an associate professor of medicine at the University of Toronto, in a statement provided by Novartis. 

The results showed trial participants who received Lutathera plus octreotide went a median of nearly two years before either cancer progression or death, compared to just eight months for those given only octreotide. The study is continuing to assess how long patients in each group lived following treatment. 

About nine in 10 participants in the Lutathera group received all four planned cycles of treatment. The most common side effects were nausea, diarrhea and abdominal pain. About five percent of Lutathera-treated patients had notable decreases in white blood cell counts.

Lutathera is what’s known as a radiopharmaceutical. The radioisotope lutetium Lu-177 dotatate is paired with a targeting ligand that seeks out a protein called SSTR that’s found on GEP-NET tumors. It’s one of two radiopharmaceutical drugs Novartis sells and its success has helped catalyze a rush of investment into the field.