Dr Halperin on the FDA Approval of Lutetium Lu 177 Dotatate for Pediatric SSTR+ GEP-NETs

Daniel M. Halperin, MD, associate professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the significance of the FDA approval of lutetium Lu 177 dotatate (Lutathera) for pediatric patients with somatostatin receptor (SSTR)–positive gastroenteropancreatic neuroendocrine tumors (GEP NETs).

 for the treatment of patients aged 12 years and older with SSTR-positive GEP-NETs, including foregut, midgut, and hindgut NETs. This regulatory decision was supported by safety findings from the phase 2 NETTER-P trial (NCT04711135), as well as safety and efficacy data from the phase 3 NETTER-1 trial (NCT01578239).

 with SSTR-positive GEP-NETs based on data from NETTER-1. NETTER-P showed that the adverse effect (AE) profile of the radiopharmaceutical in 9 pediatric patients, including 4 with GEP-NETs, was similar to that observed in adult patients. The main outcomes of NETTER-P included absorbed radiation doses in target organs and the incidence of AEs after the first treatment cycle. Secondary outcomes included short-term AEs following treatment with the radiopharmaceutical.

The recommended dose of lutetium Lu 177 dotatate is 7.4 GBq (200 mCi) every 8 weeks (± 1 week) for 4 total doses.

Since pediatric NETs are rare tumors, a dearth of research exists surrounding optimal therapies for these patients, Halperin says. The past several years have seen many research and treatment advances for adult patients with NETs, prompting oncologists who treat pediatric patients with NETs to wonder whether those therapies are applicable in pediatric populations, Halperin explains. Peptide receptor radionuclide therapies, such as lutetium Lu 177 dotatate, are effective in adult populations, and the availability of this treatment approach for pediatric patients with GEP-NETs will hopefully improve disease outcomes in that population as well, Halperin concludes.

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Daniel M. Halperin, MD, discusses the FDA approval of lutetium Lu 177 dotatate for pediatric patients with SSTR-positive GEP-NETs.

Daniel M. Halperin, MD, associate professor, Department of Gastrointestinal (GI) Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the efficacy and safety results of the phase 1/2a Protocol PEN-221-001 trial (NCT02936323) in advanced gastrointestinal (GI) mid-gut neuroendocrine tumors (NETs).

The Protocol PEN-221-001 trial evaluated PEN-221, an intravenous somatostatin analog (SSA)-DM1 conjugate, in patients with advanced or metastatic, well-differentiated, low or intermediate grade, GI mid-gut NETs. The primary end point of the study was the clinical benefit rate (CBR), Halperin says. 

The results of the study, which were presented during the 2021 NANETS Symposium, demonstrated a CBR of 88.5% with PEN-221, which exceeded the investigators previous expectations, Halperin adds. 

PEN-221 was tolerated relatively well in patients; however, pharmacokinetic and pharmacodynamic findings confirmed that PEN-221 was best dosed based on body surface area, Halperin says. This helped increase the tolerability of the agent, Halperin concludes. 

Daniel M. Halperin, MD, discusses the efficacy and safety results of the phase 1/2a Protocol PEN-221-001 trial in advanced gastrointestinal mid-gut neuroendocrine tumors.  

Daniel M. Halperin, MD,

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Dr Halperin on the FDA Approval of Lutetium Lu 177 Dotatate for Pediatric SSTR+ GEP-NETs

Dr. Halperin on the Efficacy of the Protocol PEN-221-001 Study in Advanced GI NETs