Real-World Study Finds Benefit of Lutathera in Patients With Lung NETs

Lutathera showed antitumor activity in patients with metastatic bronchopulmonary neuroendocrine tumors, based on real-world data presented at the IASLC 2025 World Conference on Lung Cancer.

Among patients treated with Lutathera (23 patients), partial responses, stable disease and progressive disease occurred in 17%, 30% and 23% of patients, respectively.

“In clinical practice, the decision of when to utilize peptide receptor radionuclide therapy varies widely, found here most commonly as a third-line systemic agent,” Dr. Giuseppe Maiocco, a resident in the Division of Internal Medicine at the Mayo Clinic and coauthors wrote in a poster presentation.

What Are the Background and Design of this Real-World Study?

Lutathera is a peptide receptor radionuclide therapy and has emerged as a promising treatment in neuroendocrine tumors with selective targeting of somatostatin receptor–expressing cells.

In April 2024, the FDA approved Lutathera for the treatment of patients 12 years of age or older with somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors. This regulatory decision represented the first FDA approval of a radioactive drug or radiopharmaceutical for this patient population.

Of note, BP-NETs comprise approximately 20% to 30% of neuroendocrine tumors and the management of metastatic BP-NETs requires substantial tailoring. Accordingly, the objective of this real-world study was to evaluate the real-world use of Lutathera in patients with BP-NETs.

In the retrospective analysis, patients with metastatic BP-NETs were treated with peptide receptor radionuclide therapy at Mayo Clinic sites in Arizona, Florida and Minnesota between 2014 and 2025. Notably, tumor grade was defined by Ki-67 score and histology was defined per World Health Organization 2017 criteria.

Primary outcomes included response rates, progression-free survival and overall survival. Response rates were assessed by 3-month post-treatment interval restaging imaging and clinician document assessment. Progression-free survival was defined as therapy initiation to any disease progression, last follow-up or death; overall survival was defined as therapy initiation to last follow-up or death.

What Were the Baseline Patient Characteristics?

In the patient population, the median age was 66 years, 39% were female and 48% had a history of tobacco use. Metastatic sites included liver (78%), bone (61%), pancreas (9%) and contralateral lung (4%). Additionally, patients had grade 1 (26%), grade 2 (39%) or grade 3 (26%) disease per World Health Organization 2017 criteria. Carcinoid histology was either typical (43%) and atypical (57%). Furthermore, the majority of patients were nonfunctional (70%), had a Krenning scale score of 4 (57%) and an ECOG performance status of 0 (57%). The median number of therapy treatments was 4. Regarding treatment history, more than half of patients received 2 systemic treatments before therapy (52%). Preceding treatments included somatostatin analog (100%), chemotherapy (65%) with 43% of patients treated with single-line chemotherapy, Afinitor (43%) and a tyrosine kinase inhibitor (9%). Notably, 43% of patients did not receive systemic treatments following therapy.

What Other Efficacy and Safety Data Were Reported?

In all patients, the median progression-free survival was 10.8 months. Moreover, in patients with typical and atypical carcinoid histology, the median progression-free survival was 11.1 months and 8.4 months. Those with a Krenning score of 4 and a Krenning score of 3 or less had a median progression-free survival of 14.7 months and 7.3 months.

The median overall survival in all patients was 35.6 months. Patients with typical and atypical carcinoid histologies had a median overall survival of 35.5 months and 19.8 months. Patients with a Krenning score of 4 or a Krenning score of 3 or less had a median overall survival of 24.4 months and 16.5 months.

Regarding side effects, the most common treatment-related side effects included fatigue (35%), nausea (26%), abdominal pain (22%) and decreased appetite (13%).

“Lutathera was well tolerated, with no grade 3 or higher side effects,” Maiocco and coauthors concluded in the poster presentation.

References

1. Maiocco G, Hazim A, Halfdanarson T, et al. Real-world outcomes of patients with bronchopulmonary neuroendocrine tumors treated with Lutetium Lu-177 dotatate. Presented at: International Association for the Study of Lung Cancer 2025 World Conference on Lung Cancer; September 6-9, 2025; Barcelona, Spain. Abstract P3.13.32.
2. FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years or older with GEP-NETS. FDA. April 23, 2024. Accessed September 9, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lutetium-lu-177-dotatate-pediatric-patients-12-years-and-older-gep-nets