Qi Xinke (iruplinalkib) / Qilu Pharma - LARVOL DELTA

Case Report: IGFBP5-ALK fusion-positive case of high-grade endometrial stromal sarcoma with response to ALK-targeted therapy. (PubMed, Front Oncol) - "After failure of gemcitabine/docetaxel chemotherapy, next-generation sequencing identified an IGFBP5-ALK fusion (breakpoint: IGFBP5 exon 1 - ALK exon 19), a TERT promoter mutation, and a homozygous CDKN2A/CDKN2B/MTAP deletion. This case highlights the first documented response to an ALK inhibitor in ALK-rearranged HG-ESS. The findings underscore the importance of comprehensive molecular profiling in identifying targetable alterations in rare sarcomas and support the use of iruplinalkib as an effective therapeutic option in this setting."

Journal • Gynecology • Oncology • Sarcoma • Solid Tumor • Uterine Cancer • ALK • BCOR • CDKN2A • CDKN2B • IGFBP5 • MTAP • TERT

Comparison of the efficacy based on clinicopathological characteristics and the safety of first-line treatments for patients with advanced ALK rearrangement non-small cell lung cancer: a network meta-analysis. (PubMed, Front Oncol) - "Specifically, lorlatinib demonstrated superior efficacy in the Non-Asian subgroup (86.8%), patients without brain metastasis (84.7%), those with Eastern Cooperative Oncology Group performance status (ECOG PS) 0/1 (78.5%), males (71.2%), females (83.9%), patients aged < 65 years (74.3%), and never-smoking patients (89.7%)...Ensartinib achieved the optimal PFS in the Asian subgroup (71.8%)...Alectinib had the lowest hepatic and gastrointestinal AEs risk, while iruplinalkib had the lowest hematological AEs risk. https://www.crd.york.ac.uk/prospero/, identifier CRD42023495527."

Journal • Retrospective data • Review • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

SAILOR: Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma After Lorlatinib (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: Peking University Shenzhen Hospital

New trial • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Real-World Observational Study of Iruplinalkib in the Treatment of ALK-Positive Non-Small Cell Lung Cancer (ChiCTR) - P=N/A | N=200 | Not yet recruiting | Sponsor: Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital ＆Institute); Shandong First Medical University

New trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

An Observational Study of the Efficacy and Safety of Iruplinalkib(WX-0593) in ALK-positive Advanced Lung Adenocarcinoma Following Lorlatinib Treatment (ChiCTR) - P=N/A | N=10 | Not yet recruiting | Sponsor: Peking University Shenzhen Hospital; Peking University Shenzhen Hospital

New trial • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Iruplinalkib (WX-0593) versus crizotinib in ALK TKI-naïve locally advanced or metastatic ALK-positive non-small cell lung cancer: interim analysis of a randomized, open-label, phase III study (INSPIRE). (PubMed, J Thorac Oncol) - P3 | "Iruplinalkib demonstrated significantly improved PFS and improved intracranial antitumor activity versus crizotinib. Iruplinalkib may be a new treatment option for patients with advanced ALK positive and ALK TKI-naïve NSCLC."

Journal • Metastases • P3 data • P3 data: top line • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

A Randomized, Phase 3 Study of Iruplinalkib (WX-0593) vs Crizotinib in Locally Advanced or Metastatic ALK+ Non-small Cell Lung Cancer (NSCLC) (IASLC-WCLC 2023) - P3 | "Iruplinalkib demonstrated significantly improved PFS versus crizotinib and higher ORR and iORR. Iruplinalkib may be a new treatment option for pts with advanced ALK+ and ALK TKI-naïve NSCLC."

Clinical • Metastases • P3 data • Brain Cancer • Cardiovascular • CNS Tumor • Hypertension • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • ROS1

Iruplinalkib Tablets as Postoperative Adjuvant Therapy in Stage IA ALK-positive NSCLC With High-risk Factors (clinicaltrials.gov) - P2 | N=28 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Safety and Efficacy of Iruplinalkib for Patients with Relapsed or Refractory (r/r) ALK+ Lymphoma: A Phase II Trial (ASH 2024) - "ALK inhibitor such as crizotinib exhibited significant effectiveness in relapsed or refractory (r/r) ALK+ lymphoma. Serious adverse events (SAEs) were not observed in all patients. No treatment discontinuation or death due to treatment-related adverse events (TRAEs) was reported.Summary/Conclusion : Iruplinalkib demonstrated a tolerable safety and a good efficacy in r/r ALK+ lymphoma patients."

Clinical • P2 data • B Cell Lymphoma • Large B Cell Lymphoma • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • ALK • IR • ROS1

Cost-effectiveness of iruplinalkib versus crizotinib in first-line anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer patients in China. (PubMed, Front Pharmacol) - "From the probabilistic sensitivity analysis (PSA), iruplinalkib had a 100% probability of being cost-effective at a willingness-to-pay threshold of $13,447.89/QALY. Compared to crizotinib, iruplinalkib is a cost-effective therapy for treatment-naïve patients with ALK-positive NSCLC."

HEOR • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Cost-effectiveness of iruplinalkib versus crizotinib in first-line anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer patients in China (Front Immunol) - "Treatment with iruplinalkib versus crizotinib resulted in a gain of 0.55 life-years, 2.11 quality-adjusted life-years (QALYs), and an incremental cost of $4,325.55, resulting in an incremental cost-effectiveness ratio of $2,048.03/QALY. Drug costs and utilities were the main drivers of the model in the deterministic sensitivity analysis."

HEOR • Non Small Cell Lung Cancer

Biomarker Analysis of Iruplinalkib Combined with Chemoradiotherapy in ALK+ Unresectable Stage ? Non-Small Cell Lung Cancer (ASTRO 2025) - P2 | "ctDNA clearance during treatment is a promising predictive biomarker of response to iruplinalkib combined with chemoradiotherapy. Dynamic ctDNA monitoring provides early insights into treatment response and relapse."

Biomarker • Tumor mutational burden • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EML4 • TMB

Neoadjuvant Iruplinalkib in Resectable ALK/ROS1 Fusion-Positive NSCLC: Updated Results of the Exploratory Neo-INFINITY Study (IASLC-WCLC 2025) - "Introduction : Previous trials showed perioperative alectinib and lorlatinib were effective for resectable ALK -positive NSCLC. The trial has progressed to Stage 2. Further data will provide insights into long-term outcomes."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • ROS1

Toxicity profiles of ROS1 tyrosine kinase inhibitors in advanced non-small cell lung cancer: a systematic review and proportional meta-analysis. (PubMed, Front Pharmacol) - "Systemic SAEs exhibited greater variability across agents, ranging from 29% to 47%: crizotinib, 43% (95% CI, 36%-49%); ceritinib, 41% (95% CI, 37%-45%); lorlatinib, 39% (95% CI, 25%-55%); entrectinib, 32% (95% CI, 28%-36%); repotrectinib, 29% (95% CI, 24%-33%); iruplinalkib, 44% (95% CI, 38%-50%); and unecritinib, 47% (95% CI, 38%-56%)...Taletrectinib and unecritinib were notably associated with hepatotoxicity...These findings will guide drug selection and safety monitoring, emphasizing the necessity of considering patients' health status, potential risk factors, and the characteristics of ROS1-TKI-related adverse reactions. https://www.crd.york.ac.uk/PROSPERO/view/CRD42024551353, identifier CRD42024551353."

Journal • Retrospective data • Review • Fatigue • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

Remarkable tumor response to Iruplinalkib in a 14-year-old girl with ALK-positive advanced metastatic non-small-cell lung cancer: a case report. (PubMed, Front Oncol) - "This case underscores the potential of Iruplinalkib, which is currently not available outside of China, to induce rapid and profound tumor regression in ALK-positive NSCLC, particularly in adolescent patients with aggressive clinical presentations. We hope that the anticancer efficacy of Iruplinalkib will be recognized globally and that it will become accessible to ALK-positive lung cancer patients worldwide."

Journal • Chronic Cough • Cough • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pain • Respiratory Diseases • Solid Tumor • ALK

Translational Model-Informed Dose Selection for Iruplinalkib, a Selective Oral ALK/ROS1 Tyrosine Kinase Inhibitor. (PubMed, Clin Transl Sci) - P1/2 | "A translational model-based approach using integrated preclinical PK/PD and PopPK modeling in patients with non-small cell lung cancer is a reliable method to predict RP2D. Trial Registration: ChiCTR.org.cn number: ChiCTR20170871; ClinicalTrials.gov identifier: NCT03389815; ChinaDrugTrials.org.cn number: CTR20190737."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • ALK • ROS1

Neo-INFINITY: Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=26 | Recruiting | Sponsor: Pingping Song | Trial completion date: Apr 2028 ➔ Mar 2029 | Trial primary completion date: Jan 2026 ➔ Mar 2027

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • ROS1

Neoadjuvant and adjuvant iruplinalkib in resectable ALK or ROS1 fusion-positive, non-small cell lung cancer (NSCLC): The preliminary results of the single-arm, exploratory Neo-INFINITY study. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT05765877 Background: The ALNEO, NAUTIKA1, and SAKULA studies found perioperative alectinib and ceritinib were effective for resectable ALK-positive NSCLC. Neoadjuvant iruplinalkib is effective and feasible for resectable ALK- or ROS1-positive NSCLC, with acceptable safety profiles. Stage 2 of the study is ongoing, and long-term results are awaited. Efficacy endpoints.Note: Data are presented as n (%)."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • ALK • ROS1

Real-world data on the efficacy and safety of iruplinalkib (WX-0593) in ALK-positive advanced lung adenocarcinoma patients previously treated with lorlatinib. (ASCO 2025) - "Iruplinalkib exhibited promising efficacy and acceptable toxicity in patients with ALK-positive advanced LUAD patients who were previously treated with lorlatinib."

Clinical • Metastases • Real-world • Real-world evidence • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Acquired ROS1 fusion and iruplinalkib response in advanced NSCLC after multiple lines of systematic therapy: a case report. (PubMed, Front Oncol) - "In December 2023, a needle biopsy of a metastasis in the left lower lobe of the lung showed a positive SDC4-ROS1 fusion. Subsequent treatment with the oral ALK TKI iruplinalkib was initiated based on the patient's preference, which exhibited a promising response over the next 2 months."

IO biomarker • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • PD-L1 • ROS1 • SDC4

Clinical practice guideline on anaplastic lymphoma kinase-tyrosine kinase inhibitors for non-small cell lung cancer (2025 edition) (PubMed, Zhonghua Zhong Liu Za Zhi) - "As of December 31, 2024, eight ALK-TKIs, including crizotinib, ceritinib, alectinib, ensartinib, brigatinib, lorlatinib, iruplinalkib, and invonalkib have garnered approval from the China National Medical Products Administration (NMPA) (Ranking according to the approval time for marketing by NMPA), providing targeted treatment agents for ALK-positive NSCLC patients. To standardize the application of ALK-TKIs, The Chinese Association for Clinical Oncologists and the Medical Oncology Branch of China International Exchange and Promotive Association for Medical and Health Care has organized experts to compile the "Clinical practice guideline on anaplastic lymphoma kinase-tyrosine kinase inhibitors for non-small cell lung cancer (2025 edition)". This guideline provides recommendations in four aspects, encompassing ALK fusion testing, ALK-TKI targeted therapy, ALK-TKI adverse events management, and patient post-treatment follow-up, thus serving as a valuable..."

Clinical guideline • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Will INSPIRE crown iruplinalkib as a new standard choice in first-line advanced ALK-positive non-small cell lung cancer? (PubMed, Transl Lung Cancer Res) - No abstract available

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

A study of Iruplinalkib in the treatment of second-generation ALK TKI-resistant non-small cell lung cancer (ChiCTR) - P4 | N=15 | Not yet recruiting | Sponsor: Sichuan Cancer Hospital; Sichuan Cancer Hospital

New P4 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

adjALK-MRD: Efficacy and safety of adjuvant ALK-TKI treatment in postoperative patients with ALK-positive stage IB-IIIA NSCLC under MRD monitoring (ChiCTR) - P4 | N=50 | Not yet recruiting | Sponsor: Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences); Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sci

New P4 trial • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Novel strategies for rare oncogenic drivers in non-small-cell lung cancer: An update from the 2024 Annual ESMO meeting. (PubMed, Lung Cancer) - "For EGFR exon 20 insertion mutation positive NSCLC, results from REZILIENT-1, a single arm phase II study with zipalertinib, were presented, showing an objective response rate (ORR) of 50% in patients that were pretreated with amivantamab, and 25% in patients pretreated with amivantamab and an EGFR exon 20 insertion-directed TKI...For ALK, results from ALKOVE-1, a single arm phase I/II study with NVL-655, a next generation ALK TKI, were presented. The ORR was 35 % in patients pretreated with ≥ 2 ALK TKIs including lorlatinib and 57 % in patients pretreated with ≥ 1 ALK TKI, excluding lorlatinib...In addition, results of the first-line randomized phase III INSPIRE study were presented, in which iruplinalkib, an ALK and ROS1 selective TKI, is being evaluated versus crizotinib...Finally, results from ARROS-1, a single arm phase I/II study with zidesamtinib, a ROS1 selective and TRK-sparing TKI, were presented. An ORR of 73% was obtained in..."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1