Qi Xinke (iruplinalkib) / Qilu Pharma - LARVOL DELTA

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

Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=26 | Recruiting | Sponsor: Pingping Song | Not yet recruiting ➔ Recruiting | Trial completion date: Jul 2025 ➔ Apr 2028 | Trial primary completion date: Mar 2025 ➔ Jan 2026

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

Iruplinalkib for G1202R-mutant non-small cell lung cancer with anaplastic lymphoma kinase double fusion failed to alectinib: a case report. (PubMed, Anticancer Drugs) - "The modeling simulation revealed that the G1202R mutation exerted little effect on the binding of iruplinalkib. Iruplinalkib showed potency to G1202R because of its unique chemical structure and removal of steric clashes, which might be a promising option for ALK-rearranged NSCLC patients with G1202R resistance mutation."

Journal • Dyslipidemia • Hypertriglyceridemia • Lung Cancer • Metabolic Disorders • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EML4

Long-term survival of an ALK fusion lung adenocarcinoma patient with high mutation burden and microsatellite instability high: a case report. (PubMed, Anticancer Drugs) - "The patient experienced progression on initial iruplinalkib and subsequent alectinib therapy within 5 months. After the failure of third-line therapy with cisplatin-pemetrexed combined with bevacizumab, she received sintilimab plus anlotinib which led to a progression-free survival of 6.5 months. She received sintilimab combined with albumin-paclitaxel plus carboplatin and achieved partial response after 6 months...After progression on ICB-based therapy, the patient was treated with lorlatinib and still under follow-up with overall survival of more than 3 years. Our findings highlight the therapeutic potential of ICB-based regimens in patients with MSI-H and ALK-rearranged NSCLC."

Journal • Tumor mutational burden • Lung Adenocarcinoma • Lung Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EML4 • MLH1 • MSI • PD-L1 • STK11 • TMB • TP53

Efficacy and safety of Iruplinalkib in real-world patients with ALK-positive and ROS1-positive NSCLC (ChiCTR) - P=N/A | N=80 | Recruiting | Sponsor: Second Hospital of Shanxi Medical University; Second Hospital of Shanxi Medical University

New trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • ROS1

Population pharmacokinetics of iruplinalkib in healthy volunteers and patients with solid tumors. (PubMed, Clin Transl Sci) - "Iruplinalkib (WX-0593), a selective oral ALK/ROS1 tyrosine kinase inhibitor, was approved in China as first-line therapy for ALK-positive non-small-cell lung cancer (NSCLC) and for the treatment of locally advanced or metastatic ALK-positive NSCLC that has progressed following crizotinib therapy. No covariate had a clinically meaningful impact on iruplinalkib exposure. These results indicate that dose adjustment of iruplinalkib is not necessary, based on the aforementioned covariates, for ALK-positive NSCLC patients."

Journal • PK/PD data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • ALK • ROS1

Evaluating the Optimal TKI for Patients With ALK Positive Advanced Non-Small-Cell Lung Cancer (aNSCLC) in the First Line (1L) Setting: An Updated Systematic Literature Review (SLR) and Network Meta-Analysis (NMA) (ISPOR-EU 2024) - "Besides alectinib and brigatinib, this analysis also included ensartinib, envonalkib and iruplinalkib. With the unprecedented CROWN 5Y data (Solomon et al., JCO 2024), the relative effect of 1L lorlatinib is significantly improved vs. other TKIs. Totality of evidence across available NMAs consistently support lorlatinib as preferred 1L treatment of choice for ALK+ aNSCLC patients."

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

Cerebrospinal Fluid Immune Microenvironment Mechanism in Anaplastic Lymphoma Kinase Positive Lung Cancer Patients (clinicaltrials.gov) - P2 | N=12 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

Metastases • New P2 trial • Brain Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • CD8 • CRP • IFNG • IL6 • TNFA • VCAM1

Economic Evaluation of Envonalkib, Iruplinalkib, and Critizonib in the Treatment of Anaplastic Lymphoma Kinase-Positive Advanced Non-Small-Cell Lung Cancer in China (ISPOR-EU 2024) - P3 | "Envonalkib is the more economical compared with iruplinalkib and critizonib at the set price(1161.78 dollar), and iruplinalkib are cost-saving and utility-increasing compared to critizonib, which can help healthcare system in making optimal policies and help clinicians in the medication of patients."

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