Phase 2 data show a progression-free survival (PFS) benefit with the combination of pasireotide and everolimus in patients with advanced neuroendocrine tumors (NETs) of the lung or thymus.

These data were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting by Eric Baudin, MD, of Gustave Roussy in Villejuif, France.

The phase 2 LUNA trial (ClinicalTrials.gov Identifier: NCT01563354) was designed to assess the efficacy and safety of pasireotide and everolimus alone or in combination in patients with advanced NETs of the lung or thymus.


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The trial included 124 adults. They were randomized 1:1 to receive pasireotide at 60 mg/month, everolimus at 10 mg/day, or pasireotide plus everolimus.

The core phase of the study lasted 12 months. In the extension phase, patients could continue on study treatment until they no longer derived a benefit from it or if they met discontinuation criteria.

Dr Baudin presented results from the extension phase, which included 41 patients with a median age of 61 years. There were 12 patients who received pasireotide alone, 14 who received everolimus alone, and 15 who received the drugs in combination.

The lung was the primary cancer site in 95.1% of patients, and 82.9% had nonfunctioning tumors. A majority of patients (63.4%) had prior surgery or local-regional therapy.

Disease progression was the primary reason for treatment discontinuation across the 3 study arms, with 65.9% of the patients discontinuing during the extension phase.

The median duration of exposure to the pasireotide-everolimus combination was 49 weeks. At least 1 dose reduction of pasireotide or everolimus was reported in more than half of the patients.

The median PFS was 8.5 months in the pasireotide arm, 12.5 months in the everolimus arm, and 16.5 months in the combination arm.

The median biochemical PFS was 2.9 months in both the pasireotide and everolimus arms and 5.6 months in the combination arm.

Twelve deaths were reported up to 56 days from the last dose of study treatment — 2 in the pasireotide arm, 7 in the everolimus arm, and 3 in the combination arm.

The most common adverse events (AEs) of any grade in the combination arm were hyperglycemia (87.8%), diarrhea (80.5%), and weight loss (58.5%). The most common AEs in the pasireotide arm were hyperglycemia (43.9%), weight loss (43.9%), and diarrhea (41.5%). The most common AEs in the everolimus arm were stomatitis (61.9%), diarrhea (50.0%), and weight loss (45.2%).

No AEs with fatal outcomes were reported in the pasireotide arm. Three fatal AEs possibly related to everolimus were acute kidney injury (everolimus arm), diarrhea (combination arm), and respiratory failure (combination arm).

“The safety and tolerability profile of pasireotide and everolimus alone or in combination were consistent with prior experience of these treatments in the oncology setting, with no new safety signals being reported during the study,” Dr Baudin said.

He noted that post hoc prognostic studies are ongoing.

Disclosures: There was no funding for the current research, but the LUNA trial was supported by Novartis. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Baudin E, Berruti A, Giuliano M, et al. First long-term results on efficacy and safety of long-acting pasireotide in combination with everolimus in patients with advanced carcinoids (NET) of the lung/thymus: phase II LUNA trial. J Clin Oncol. 2021;39:(suppl 15; abstr 8574). doi:10.1200/JCO.2021.39.15_suppl.8574

This article originally appeared on Cancer Therapy Advisor