From May 30 to June 3, 2025, the annual meeting of the American Society of Clinical Oncology (ASCO), the top academic conference in the global oncology field, will be held in Chicago. Two research achievements of Qilu Pharmaceutical's first innovative drug, Irualk, have been accepted as a poster (Abstract#8638) and for online publication (e20044) at the 2025 ASCO Annual Meeting. These two research achievements are respectively from Peking University Shenzhen Hospital, Shandong Cancer Hospital, and Liaoning Cancer Hospital.Real-World Data on the Efficacy and Safety of Iruac in Lorlatinib-Treated ALK-Positive Advanced Lung Adenocarcinoma Patients'%20fill='%23FFFFFF'%3E%3Crect%20x='249'%20y='126'%20width='1'%20height='1'%3E%3C/rect%3E%3C/g%3E%3C/g%3E%3C/svg%3E)
"Iruac for Neoadjuvant Treatment of Resectable ALK/ROS1-Positive Non-Small Cell Lung Cancer: A Single-Arm Exploratory Clinical Study (FL006-IIT-001, NCT05765877)" is a multicenter, prospective clinical study enrolling patients with initially resectable ALK or ROS1-positive NSCLC. The treatment model includes neoadjuvant therapy, surgery, and adjuvant therapy, with the primary endpoint being the major pathological response rate (MPR). The study uses a Simon two-stage design. In the first stage, 8 patients were enrolled, including 2 ROS1-positive and 6 ALK-positive cases. Among the 8 participants, the MPR and pathological complete response rate (pCR) reached 50% and 25%, respectively, while the objective response rate (ORR) and R0 resection rate both reached 100%. For the 6 ALK-positive patients, the MPR and pCR rates were 67% and 33%, respectively. Two patients experienced ≥Grade 3 treatment-related adverse events (TRAEs), one required dose reduction due to TRAEs, and no cases of TRAE-induced treatment interruption or discontinuation occurred. The results of the first stage met expectations, and the second stage is currently ongoing with continued enrollment. This study is expected to provide evidence for neoadjuvant treatment in early-stage ALK-positive NSCLC.In 2025, Iruac achieved fruitful results, with multiple research findings accepted and published by academic conferences and journals both in China and internationally. The biomarker analysis results of the clinical study "Iruac Combined with Chemoradiotherapy in the Treatment of Unresectable Locally Advanced ALK-positive NSCLC (FL006-IIT-002, NCT05765877)" were accepted for poster presentation at the 2025 American Society for Radiation Oncology (ASTRO) Annual Meeting.#70544); Meanwhile, the updated data results of the ALK population in the "Single-Arm Exploratory Clinical Study of Iruac for Neoadjuvant Treatment of Resectable ALK/ROS1-Positive Non-Small Cell Lung Cancer (FL006-IIT-001, NCT05765877)" were accepted as a poster (#1948) by the 2025 World Conference on Lung Cancer (WCLC); Since the launch of Iruac, a total of 14 research data have been received and accepted by top domestic and international academic conferences such as ASCO, ESMO, WCLC, ASTRO, AACR, and CSCO, achieving "zero rejection"; Six SCI full-text articles have been published, with a cumulative impact factor exceeding 52 points. In January 2025, the "Clinical Diagnosis and Treatment Guidelines for Brain Metastasis of Chinese Driver Gene-Positive Non-Small Cell Lung Cancer (2025 Edition)" was officially published in the Chinese Journal of Lung Cancer, recommending Iruac for brain metastasis ALK-positive NSCLC, with an evidence level of 2B; In April, the "CSCO Diagnosis and Treatment Guidelines for Driver Gene-Positive NSCLC (2025)" were officially released, recommending Iruac as a Level I recommendation for ALK-positive NSCLC, with an evidence level of 1A; Meanwhile, the "Chinese Treatment Guidelines for Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitors in the Treatment of Non-Small Cell Lung Cancer (2025 Edition)" were officially published in the Chinese Journal of Oncology, citing the updated data of the primary endpoint PFS (median value 45.9 months) from the Phase III clinical study of Iruac as first-line treatment for ALK-positive NSCLC. To date, Iruac has been recommended by seven authoritative guidelines/consensus in China.Second Review | Li Fangchen
Third Review | Li Jingzhi
