Qi Xinke (iruplinalkib) / Qilu Pharma - LARVOL DELTA

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

Case Report: Lorlatinib combined with chemotherapy and anti-angiogenic therapy shows promising efficacy in an ALK gene fusion lung adenocarcinoma patient with iruplinalkib resistance. (PubMed, Front Pharmacol) - "We thereafter modified the therapeutic strategy to include lorlatinib-based targeted therapy combined with a dual-agent chemotherapy regimen consisting of cisplatin and pemetrexed, along with bevacizumab for anti-angiogenic therapy. Following this adjustment, the patient's malignant pleural effusion showed marked remission. For patients with NSCLC harboring the EML4-ALK V5' fusion variant who have developed resistance to second-generation tyrosine kinase inhibitors (TKIs), switching to third-generation TKI lorlatinib in combination with chemotherapy and anti-angiogenic treatment may serve as a potential therapeutic option for overcoming acquired resistance and curbing rapid disease progression."

Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • ALK • EML4

Cost-Effectiveness Analysis of the Five First-line Treatment Regimens for ALK-positive NSCLC in China: An Economic Evaluation Based on Network Meta-Analysis. (PubMed, Value Health) - "For patients with advanced ALK-positive NSCLC in China, lorlatinib, alectinib, brigatinib, and iruplinalkib are cost-effective compared to crizotinib, with the exception of ensartinib. Among these, iruplinalkib is the most cost-effective TKI for first-line treatment, followed by lorlatinib."

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

Clinical Evaluation of Anaplastic Lymphoma Kinase (ALK) Inhibitors for the First-Line Treatment of Advanced ALK-Positive Non-Small Cell Lung Cancer Based on the 2nd Edition of China's Drug Evaluation and Selection Guideline. (PubMed, Drug Des Devel Ther) - "The final assessment result scores from highest to lowest were alectinib (78.70 points), lorlatinib (78.70 points), brigatinib (78.50 points), ensartinib (73.30 points), iruplinalkib (72.55 points), ceritinib (71.50 points), envonalkib (71.15 points), crizotinib (70.60 points). Based on the second edition of China's drug evaluation and selection guideline and combined with the clinical application characteristics of ALK inhibitors, this study performed a multidimensional scoring of eight ALK inhibitors. The evaluation results could provide a reference for medical institutions in the introduction and elimination of ALK inhibitors."

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

Durable response to ALK inhibition in low-allele-frequency SPTBN1-ALK-rearranged gastric cancer followed by lineage plasticity-mediated resistance: a case report. (PubMed, Front Oncol) - "After failure of chemotherapy combined with immunotherapy, treatment with the ALK inhibitor iruplinalkib resulted in rapid clinical improvement and a durable partial response lasting approximately 14 months...It also illustrates the dynamic evolutionary trajectory of oncogene-driven tumors under therapeutic pressure, with histologic transformation to small-cell neuroendocrine carcinoma that may reflect lineage plasticity. Comprehensive genomic profiling and longitudinal molecular monitoring may facilitate the identification of rare actionable alterations and improve understanding of resistance mechanisms in advanced gastric cancer."

IO biomarker • Journal • Endocrine Cancer • Gastric Adenocarcinoma • Gastric Cancer • Lung Cancer • Microsatellite Instability • Oncology • Solid Tumor • HER-2 • MSI • PD-L1 • RB1 • TP53

Expert consensus on iruplinalkib for the treatment of ALK-positive non-small cell lung cancer (2026 edition) (PubMed, Zhonghua Zhong Liu Za Zhi) - "Currently, the China National Medical Products Administration (NMPA) has approved ten ALK-TKIs, including crizotinib, ceritinib, alectinib, ensartinib, brigatinib, lorlatinib, iruplinalkib, envonalkib, dirozalkib and conteltinib. This consensus provides systematic and comprehensive update of clinical research data on iruplinalkib published before June 25, 2026, based on the 2024 edition. It covers common clinical issues and provides corresponding recommendations for the use of iruplinalkib in the treatment of ALK-positive NSCLC."

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

Efficacy and Safety of Irulac as a single agent or in combination with local radiotherapy in the Treatment of Non-Small Cell Lung Cancer Patients with ALK-TKIs Resistance (ChiCTR) - P=N/A | N=17 | Not yet recruiting | Sponsor: Yantai Yuhuangding Hospital; Yantai Yuhuangding Hospital

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

Importance of Multimodal Testing for Novel ALK Fusions: A Case of MTHFD1L-ALK Positive Lung Squamous Cell Carcinoma With Negative IHC. (PubMed, Thorac Cancer) - "The patient initially received induction therapy with the ALK TKI iruplinalkib, achieving a best response of stable disease (SD)...Subsequent lorlatinib provided limited benefit, with disease progression at 5.3 months following treatment self-discontinuation. Retrospective immunohistochemical staining of ALK (D5F3) was negative despite the positive genomic finding. This case demonstrates limited clinical benefit from ALK inhibitors in LSCC with this novel fusion, expands the known mutational spectrum in non-small cell lung cancer (NSCLC), and underscores the critical importance of confirming novel fusions at the protein expression level through multimodal testing."

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

Case Report: Recurrent uterine inflammatory myofibroblastic tumor harboring IGFBP5-ALK fusion with sustained response to iruplinalkib. (PubMed, Front Oncol) - "Then the patient was recommended ALK-TKIs treatment after detecting ALK rearrangement, and achieved complete response (CR) from a second-generation ALK-TKI inhibitor, iruplinalkib, after resistance to the first-generation inhibitor crizotinib. This is the first case of iruplinalkib achieved therapeutic success in uterine IMT, suggesting that a sequential ALK-TKIs with iruplinalkib could be an optimal targeted therapeutic strategy for ALK-rearranged IMTs."

Journal • Leiomyosarcoma • Oncology • Sarcoma • Solid Tumor • ALK • IGFBP5

Comparative effectiveness of ALK tyrosine kinase inhibitors in ALK-positive non–small cell lung cancer: A systematic review and network meta-analysis. (ASCO 2026) - "Lorlatinib ranked highest (HR 0.19, 95% CrI 0.13-0.27; SUCRA 0.91), followed by foritinib (HR 0.23) and iruplinalkib (HR 0.31). Next-generation ALK-TKIs significantly outperform crizotinib. Lorlatinib demonstrated greatest PFS and intracranial benefit, while alectinib showed durable efficacy with high-certainty evidence, supporting current guidelines. Table."

HEOR • Retrospective data • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Real-world efficacy and safety of iruplinalkib in ALK -positive advanced lung adenocarcinoma patients previously treated with lorlatinib. (ASCO 2026) - P=N/A | "In this updated analysis, iruplinalkib demonstrated durable clinical efficacy in heavily pretreated ALK-positive LUAD patients progressing on lorlatinib, including those with a high burden of brain metastases. The median PFS of 12.4 months and OS of 22.1 months in a ≥ 4th-line setting supports iruplinalkib as a promising salvage option. Baseline Characteristics and Clinical Outcomes"

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

Remarkable Response to Iruplinalkib in an Elderly Patient with Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer: A Case Report. (PubMed, Case Rep Oncol) - "This case demonstrates that iruplinalkib exhibits excellent efficacy and tolerability in elderly patients with ALK-positive NSCLC, even in those presenting with advanced disease and poor initial performance status. Age alone should not preclude consideration of targeted therapy when actionable driver mutations are identified."

Journal • Lung Adenocarcinoma • Lung Cancer • Musculoskeletal Diseases • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • ALK

Short-term response to alectinib and rapid progression in a lung squamous cell carcinoma patient harboring an EML4-ALK fusion: a case report. (PubMed, Transl Cancer Res) - "The patient received two cycles of nab-paclitaxel and carboplatin, and repeated CT scan showed disease progression. Her treatment was subsequently changed to glumetinib plus iruplinalkib and she died less than one month later...Co-amplification of the multiple genes may be involved in aggressive disease and drug resistance, which should be considered in future clinical trials and clinical management. Early broad-panel next-generation sequencing testing in LUSCC patients who are never-smokers may help guide management for patients who have complex mutational profiles."

Journal • Cervical Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • ALK • CCND1 • CDK4 • CDKN2A • EML4 • FGF19 • FGF3 • FGF4 • MDM2

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 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