WCLC 2025 - Posters & ePosters-P1.11.74 Phase Ib Study of Golidocitinib Plus Anti-PD-1 in Anti-PD-1 Treated Advanced NSCLC: Dose-Escalation Safety Using BOIN Design

P1.11.74 Phase Ib Study of Golidocitinib Plus Anti-PD-1 in Anti-PD-1 Treated Advanced NSCLC: Dose-Escalation Safety Using BOIN Design

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This phase Ib study evaluated the safety and dose escalation of golidocitinib, a selective JAK1 inhibitor, combined with anti-PD-1 therapy in patients with advanced non-small cell lung cancer (NSCLC) who had progressed after first-line anti-PD-1 treatment. Resistance to immune checkpoint inhibitors (ICIs) in NSCLC leads to limited options; preclinical data suggest JAK inhibitors may synergize with anti-PD-1 therapy.<br /><br />The single-arm, single-center study used a Bayesian Optimal Interval (BOIN) design to identify the recommended phase II combination dose (RP2CD). Dose escalation tested golidocitinib at 75 mg and 150 mg daily combined with anti-PD-1 (200 mg every 3 weeks). Six patients were enrolled in the dose-escalation phase, all with adenocarcinoma histology and advanced stage IV disease. Best responses to first-line treatment were stable disease or partial response, with progression-free survival ranging from 5.5 to 30.6 months.<br /><br />No dose-limiting toxicities (DLTs) occurred during the 28-day evaluation period at either dose level, and no adverse events above grade 2 were reported. Observed treatment-emergent adverse events were mostly mild to moderate, including electrolyte imbalances (hyponatremia, hypokalemia), lab abnormalities (proteinuria, elevated liver enzymes), and gastrointestinal symptoms. No treatment discontinuations or deaths related to toxicity occurred.<br /><br />The study concluded that combining golidocitinib at 150 mg daily with anti-PD-1 agents is well tolerated in immune-resistant NSCLC patients, with a favorable safety profile and no DLTs. Ongoing enrollment and data collection aim to further clarify the clinical efficacy and utility of this combination in NSCLC. This approach holds promise to overcome resistance to ICIs by leveraging the synergistic effects of JAK1 inhibition and PD-1 blockade.<br /><br />ClinicalTrials.gov ID: NCT06690671. Correspondence: Prof. Hua Zhong, Shanghai Chest Hospital.

Asset Subtitle

Hua Zhong

Meta Tag

Speaker Hua Zhong

Topic Metastatic Non-small Cell Lung Cancer – Immunotherapy

Keywords

golidocitinib

JAK1 inhibitor

anti-PD-1 therapy

non-small cell lung cancer

NSCLC

immune checkpoint inhibitors

dose escalation

phase Ib study

Bayesian Optimal Interval design

treatment-emergent adverse events