WCLC 2025 - Posters & ePosters-P1.07.38 Neoadjuvant Iruplinalkib in Resectable ALK/ROS1 Fusion-Positive NSCLC: Updated Results of the Exploratory Neo-INFINITY Study

P1.07.38 Neoadjuvant Iruplinalkib in Resectable ALK/ROS1 Fusion-Positive NSCLC: Updated Results of the Exploratory Neo-INFINITY Study

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The Neo-INFINITY phase II study explores the efficacy and safety of neoadjuvant and adjuvant iruplinalkib, a novel ALK/ROS1 inhibitor, in patients with resectable ALK/ROS1 fusion-positive non-small cell lung cancer (NSCLC). ALK fusions represent about 5.6% of NSCLC cases, and previous studies have shown benefits of perioperative ALK inhibitors. This single-arm study enrolled 11 ALK-positive NSCLC patients between February 2023 and March 2025.<br /><br />Eligible patients were adults with pathologically confirmed resectable NSCLC (stages B–A or B with T3N2M0) harboring ALK/ROS1 fusions, measurable lesions, good performance status (ECOG 0), and adequate organ function. They received eight weeks of neoadjuvant oral iruplinalkib (initially 60 mg/day for 7 days, then 180 mg/day), followed by surgery within four weeks, and adjuvant iruplinalkib for up to two years post-surgery.<br /><br />In this interim analysis of 10 patients who completed neoadjuvant therapy and surgery, the major pathologic response (MPR) rate was 50%, with 30% achieving a pathologic complete response (pCR). Radiologic objective and disease control rates were 90% and 100%, respectively, with 40% showing tumor downstaging. All patients underwent successful R0 resection. The median residual viable tumor was 18%. Treatment was well tolerated; 18% experienced grade 3 adverse events (AEs) related to iruplinalkib, with no serious AEs or treatment discontinuations. Dose interruptions or reductions occurred in some cases.<br /><br />Most patients were non-smokers with adenocarcinoma histology, and surgery was mostly thoracoscopic lobectomy. Adjuvant treatment was initiated promptly post-surgery in the majority.<br /><br />In conclusion, neoadjuvant iruplinalkib shows promising efficacy and a favorable safety profile in resectable ALK-positive NSCLC. The ongoing Neo-INFINITY trial will provide further data on long-term benefits of perioperative iruplinalkib therapy.

Asset Subtitle

Guodong Zhang

Meta Tag

Speaker Guodong Zhang

Topic Early-Stage Non-small Cell Lung Cancer

Keywords

Neo-INFINITY phase II study

neoadjuvant iruplinalkib

adjuvant iruplinalkib

ALK/ROS1 fusion-positive NSCLC

non-small cell lung cancer

major pathologic response (MPR)

pathologic complete response (pCR)

perioperative ALK inhibitors

tumor downstaging

R0 resection