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Association details:
| Biomarker: | ALK positive |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Qi Xinke (iruplinalkib) (ALK inhibitor, ROS1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Title:
Iruplinalkib Tablets approved for marketing by China NMPA
Published date:
07/11/2023
Excerpt:
...Iruplinalkib Tablets...of Qilu Pharmaceuticals Co., Ltd is approved by China NMPA. It is indicated for the treatment of anaplastic lymphoma kinase (ALK) positive and locally advanced or metastatic non-small cell lung cancer (NSCLC) patients who have been treated with crizotinib and experienced disease progression or who are crizotinib -resistant.
Source:
Title:
A Randomized, Phase 3 Study of Iruplinalkib (WX-0593) vs Crizotinib in Locally Advanced or Metastatic ALK+ Non-small Cell Lung Cancer (NSCLC)
Published date:
08/08/2023
Excerpt:
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.
Trial ID:
Source:
Title:
A Study Evaluates the Safety and Efficacy of WX-0593 in ALK -Positive, or ROS1-positive Non-small Cell Lung Cancer
Excerpt:
...Histologically or cytologically confirmed advanced ALK-positive NSCLC in upper first-class hospitals，or histologically or cytologically confirmed advanced ROS1-positive NSCLC in a central laboratory....
Trial ID:
Source:
Title:
Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer
Excerpt:
...- ALK-positive or ROS1-positive NSCLC in Stage IB-IIIA (according to the 8th American Joint Committee on Cancer TNM edition), as assessed by investigator....
Trial ID:
More C2 evidence
Source:
Title:
Study Comparing WX-0593 to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients
Excerpt:
...Histologically or cytologically confirmed diagnosis of advanced or recurrent or metastatic NSCLC that is ALK-positive by an Abbott FISH assay in the central lab....
Trial ID:
Source:
Title:
Real-World Study of Iruplinalkib in the Treatment of ALK-Positive Non-Small Cell Lung Cancer
Excerpt:
...- Patients with ALK-positive non-small cell lung cancer...
Trial ID:
Less C2 evidence
Source:
Title:
556P - Results from the phase I study on efficacy and safety of iruplinalkib (WX-0593) for anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) patients who received prior second-generation ALK tyrosine kinase inhibitors (TKIs)
Published date:
11/27/2023
Excerpt:
Iruplinalkib demonstrated promising efficacy and acceptable toxicity in ALK-positive advanced NSCLC patients previously treated with second-generation ALK TKIs.
Trial ID:
Source:
Title:
Efficacy and safety of iruplinalkib (WX-0593) in ALK-positive crizotinib-resistant advanced non-small cell lung cancer patients: a single-arm, multicenter phase II study (INTELLECT)
Published date:
02/24/2023
Excerpt:
IRC-assessed ORR and disease control rate (DCR) were 69.9% (95% CI 61.7-77.2%) and 96.6% (95% CI 92.2-98.9%), respectively. Investigator-assessed ORR and DCR were 63.0% (95% CI 54.6-70.8%) and 94.5% (95% CI 89.5-97.6%), respectively. Investigator-assessed median duration of response and progression-free survival (the same as median time to progression) were 13.2 months (95% CI 10.4-17.7) and 14.5 months (95% CI 11.7-20.0), respectively....In this study, iruplinalkib (WX-0593) demonstrated favorable efficacy and manageable safety profiles in patients with ALK-positive crizotinib-resistant advanced NSCLC.
DOI:
10.1186/s12916-023-02738-5
Trial ID:
Source:
Title:
A phase II trial of ALK/ROS1 tyrosine kinase inhibitor WX-0593 (iruplinalkib) in ALK-positive and crizotinib-resistant advanced non–small cell lung cancer.
Published date:
05/26/2022
Excerpt:
The IRC-assessed ORR was 67.8% (95% CI 59.6%-75.3%)….WX-0593 showed promising activity against ALK-positive NSCLC after crizotinib resistance and favorable safety profile, demonstrating WX-0593 could be a new treatment option for this patient population.
DOI:
10.1200/JCO.2022.40.16_suppl.9073
Trial ID:
