2023 World Conference on Lung Cancer (Posters)-P2.01. Restoring Lymphocytes Using NKTR-255 after Chemoradiotherapy in Solid Tumors (RESCUE)

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Researchers are conducting a phase II trial to investigate the safety and efficacy of NKTR-255, a polymer-conjugated interleukin-15 (IL-15) agonist, in combination with durvalumab in patients with locally advanced non-small cell lung cancer (NSCLC) who have undergone chemoradiation therapy (CRT). Radiation-induced lymphopenia (RIL) is a common side effect of radiation therapy, and severe RIL can negatively impact patient outcomes and hinder the effectiveness of immunotherapy. The primary objectives of the trial are to assess the safety of NKTR-255 after CRT, particularly in relation to treatment-related grade 3 radiation pneumonitis, and to estimate the restoration of lymphocyte counts after the administration of NKTR-255 along with durvalumab. Secondary objectives include investigating the pharmacokinetics, immunogenicity, and immune profile changes associated with NKTR-255. The trial aims to enroll 30 patients aged 18 and older with locally advanced NSCLC who have received standard CRT followed by one year of durvalumab. NKTR-255 will be administered intravenously at a dose of 3 mcg/kg, with the first dose given within 72 hours of completing CRT and subsequent doses given concurrently with durvalumab every 4 weeks. Blood samples will be collected to assess lymphocyte counts and NK cell, CD4 T cell, CD8 T cell, and B cell levels. The trial began in January 2023, and as of now, 9 patients have been enrolled. The researchers expect that NKTR-255 will improve lymphocyte counts and potentially enhance patient outcomes following CRT in NSCLC. Interleukin-15 is a cytokine that plays a crucial role in immune function and has been identified as a promising immunotherapy agent. NKTR-255 is a conjugated form of IL-15 that exhibits sustained pharmacodynamic effects and improved pharmacokinetic properties, leading to enhanced in vivo efficacy. The trial will also evaluate the safety of the treatment regimen and apply interim futility rules and safety rules for statistical monitoring.

Asset Subtitle

Steven Lin

Meta Tag

Speaker Steven Lin

Topic Local-Regional NSCLC: Novel Therapies & Trials

Keywords

NKTR-255

phase II trial

interleukin-15 agonist

durvalumab

non-small cell lung cancer

chemoradiation therapy

radiation-induced lymphopenia

pharmacokinetics

immunogenicity

immune profile changes