Qi Xinke (iruplinalkib) / Qilu Pharma - LARVOL DELTA

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

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

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

Post-Market Surveillance Study of ALK-Positive Advanced NSCLC Participants Treated With Iruplinalkib (clinicaltrials.gov) - P=N/A | N=1000 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

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

Update of the INSPIRE study: Iruplinalkib versus crizotinib in ALK TKI-naïve locally advanced or metastatic ALK+ non-small cell lung cancer (NSCLC) (ESMO 2024) - P3 | "These results demonstrated iruplinalkib continued to improve PFS versus crizotinib in pts with advanced ALK+ and ALK TKI-naïve NSCLC. The safety profile was consistent with prior results and no new safety findings was observed. Table: 1278P Updated survival results of iruplinalkib versus crizotinib Note: ALK+ pts were those whose ALK status was confirmed positive by both central laboratory and local hospitals."

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

Chemoradiotherapy (CRT) Combined with Consolidative Iruplinalkib for ALK/ROS1+ Unresectable Non-Small Cell Lung Cancer (NSCLC): ALK+ Cohort Results from Part 1 of the INNOVATION Study (ASTRO 2024) - "Purpose/Objective(s): The standard of care for unresectable NSCLC is consolidative durvalumab plus CRT. CRT + consolidative iruplinalkib was well-tolerated and had encouraging efficacy in ALK+ unresectable NSCLC. This innovative regimen may be an ideal option for this population. Abstract 2166 – Table 1 Parameters Results (n=7) Adenocarcinoma 7 (100) Stage ?"

Dyslipidemia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Solid Tumor • ALK • ROS1

A real-world study of iruplinalkib in patients with locally advanced or metastatic ALK-positive non-small-cell lung cancer (ChiCTR) - P4 | N=105 | Not yet recruiting | Sponsor: Jiangsu Provincial Hospital; Jiangsu Province Hospital

Metastases • New P4 trial • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Iruplinalkib in Patients with ALK-Positive Crizotinib-Resistant NSCLC: Updated Efficacy and Safety Data from a Phase 2 Trial (IASLC-WCLC 2024) - P2 | "The most common subsequent anti-tumor therapy was ALK TKI (73 [50.0%]), of which alectinib accounted for the most (50 [34.2%]). The updated results provided new evidence for the use of iruplinalkib in patients with ALK-positive crizotinib-resistant advanced NSCLC. Investigator-assessed response in pts with measurable intracranial lesions and with CNS metastases Per investigator Patients with measurable intracranial lesions (n=42) Patients with central nervous system metastases (n=90) Best of response, n (%) Complete response 3 (7.1%) 0 Partial response 24 (57.1%) 50 (55.6%) Stable disease 13 (31.0%) 34 (37.8%) Progressive disease 1 (2.4%) 4 (4.4%) Not evaluable 1 (2.4%) 2 (2.2%) Objective response rate, n (%) 27 (64.3%) 50 (55.6%) 95% confidence interval 48.0% to 78.4% 44.7% to 66.0% Disease control rate, n (%) 40 (95.2%) 84 (93.3%) 95% confidence interval 83.8% to 99.4% 86.1% to 97.5% Median duration of response, months 18.69 17.25 95% confidence interval 15.01 to..."

Clinical • P2 data • Cerebral Hemorrhage • CNS Disorders • Dyslipidemia • Hematological Disorders • Lung Cancer • Metabolic Disorders • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Efficacy of ALK inhibitors in Asian patients with ALK inhibitor-naïve advanced ALK-positive non-small cell lung cancer: a systematic review and network meta-analysis. (PubMed, Transl Lung Cancer Res) - "Eight studies, involving 1,477 Asian patients and seven treatments (crizotinib, alectinib, brigatinib, ensartinib, envonalkib, iruplinalkib, and lorlatinib), were included in the NMA. Next-generation ALK inhibitors had better efficacy than crizotinib in the treatment of Asian patients with ALK inhibitor-naïve advanced ALK-positive NSCLC. Iruplinalkib may have more favorable PFS benefit than other ALK inhibitors for Asians."

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

Updated Data from Phase II Clinical Trial of Iruplinalkib Tablets (Qixinke) Presented at World Conference on Lung Cancer 2024 (PRNewswire) - P2 | N=176 | INTELLECT (NCT04641754) | Sponsor: Qilu Pharmaceutical Co., Ltd. | "During the World Conference on Lung Cancer (WCLC)...updated findings from the Phase II clinical trial (INTELLECT study) were presented....A total of 146 subjects were enrolled in this study. As of December 29, 2023, the median follow-up time was 42.41 months, revealing a median overall survival (OS) of 41.79 months. The investigator-evaluated objective response rate (ORR) was 63.7%, while the disease control rate (DCR) reached 94.5%. Additionally, the median duration of response (DoR) and median progression-free survival (PFS) were reported to be 14.06 months and 14.55 months, respectively. According to the RECIST v1.1 evaluation criteria, the ORR and DCR in the subgroup with CNS metastasis at baseline (90 patients) were 55.6% and 93.3%, respectively. Both the median DoR and median PFS were 17.25 months, while the median OS stood at 43.01 months."

P2 data • Non Small Cell Lung Cancer

Iruplinalkib (WX-0593), the Seventh ALK Tyrosine Kinase Inhibitor Approved in People's Republic of China With More to Come. (PubMed, J Thorac Oncol) - No abstract available

Journal