Preliminary results from a phase 3 trial determined that first line treatment with Lutathera (lutetium Lu 177-dotatate) improves progression-free survival outcomes for patients with grade 2 and 3 advanced gastroenteropancreatic neuroendocrine tumors (GEP-NET).
Lutathera is a type of radioactive drug that treats patients with GEP-NET. The drug binds to a receptor called somatostatin — found on some neuroendocrine tumor cells — in which Lutathera builds up in the cancer cells and gives off radiation to destroy them, according to the National Cancer Institute.
Lutathera was approved by the U.S. Food and Drug Administration (FDA) in early 2018 to treat patients with somatostatin receptor-positive GEP-NETs.
GEP-NETs are rare types of tumors that can form in the pancreas or in the gastrointestinal tract, which includes the stomach, small intestine, colon, rectum and appendix, according to the National Cancer Institute. These tumors typically form in cells that secrete hormones; however, when these tumors produce excess hormones and other substances, it may cause signs and symptoms of disease, National Cancer Institute explained.
Grade 2 tumors are between low- and high-grade tumors, whereas grade 3 tumors have cells that appear abnormal and multiply quickly, according to the American Cancer Society.
The phase 3 trial NETTER-2 analyzed the treatment combination of Lutathera with long-lasting Sandostatin (octreotide, a drug similar to naturally occurring growth hormone inhibitor somatostatin) for newly diagnosed patients with advanced GEP-NETs who are somatostatin receptor-positive.
The trial included 222 patients, who were randomly assigned among two groups. One group of patients received the treatment combination of Lutathera and Sandostatin and the other group of patients received Sandostatin alone, according to clinicaltrials.org.
A recent press release from Novartis, the manufacturer of Lutathera, noted that the trial met its primary endpoint (the result measured at the end of a study to see if treatment was effective), which was progression-free survival (the period during and after treatment when the disease does not worsen), based on preliminary data.
The trial also met its key secondary endpoint, which was overall response rate (the percentage of patients whose cancer shrinks following treatment), according to the release.
“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 and global head of oncology development at Novartis, in the press release.
Overall, the researchers from the trial established that the preliminary results suggest significant benefits for patients with GEP-NET and the data regarding the safety profile of Lutathera remained consistent with past data.
The press release also stated that the FDA approval of Lutathera was based on a previous trial, NETTER-1, which showed highly significant outcomes for progression-free survival in patients with somatostatin receptor-positive, inoperable midgut neuroendocrine tumors who progressed despite standard treatment, receiving the treatment combination of Lutathera plus Sandostatin. Patients in the NETTER-1 trial also received either Lutathera plus Sandostatin or Sandostatin alone.
Findings from the trial will soon be presented at a medical meeting, the press release stated, and will be further discussed with regulatory authorities.
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