Ensacove (ensartinib) / Betta Pharma 
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 1 Disease   21 Trials   21 Trials   381 News 


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  • ||||||||||  Ensacove (ensartinib) / Xcovery
    Trial completion date, Trial primary completion date:  Treating Patients With Melanoma and ALK Alterations With Ensartinib (clinicaltrials.gov) -  Jan 26, 2022   
    P2,  N=18, Active, not recruiting, 
    The quantitative radiomic signature provided added prognostic prediction value to the clinicopathological features. Trial completion date: Jan 2022 --> Jan 2023 | Trial primary completion date: Jan 2022 --> Jan 2023
  • ||||||||||  Ensacove (ensartinib) / Xcovery
    Trial completion date:  Ensartinib in Non-small Cell Lung Cancer Patients With Positive ALK (clinicaltrials.gov) -  Nov 24, 2021   
    P1,  N=24, Recruiting, 
    The implementation of a newer generation of ALK-TKIs in the first-line treatment of ALK-positive NSCLC into current clinical practice is evolving rapidly. Trial completion date: Dec 2020 --> Dec 2022
  • ||||||||||  ensartinib (X-396) / Xcovery
    [VIRTUAL] Unique Efficacy of Ensartinib on Different ALK Fusion Subtypes Evaluated by Plasma ctDNA (ePoster Hall) -  Aug 9, 2021 - Abstract #IASLCWCLC2021IASLC_WCLC_1014;    
    Ensartinib, a next generation ALK TKI approved by NMPA in China, showed comparable efficacy to other ALK TKIs in the post-crizotinib setting...Conclusion Consistent with previous reports, ensartinib showed high clinical efficacy. In particular, the similar efficacy of ensartinib between V1 and V3 subtypes and its non-inferior efficacy on the low-level ctDNA group differentiate ensartinib from other ALK-TKIs and provide directions for future clinical trial validation.
  • ||||||||||  Lorbrena (lorlatinib) / Pfizer
    [VIRTUAL] Lorlatinib in First Line Treatment of Patients With ALK - Positive NSCLC: A Network Meta - Analysis (ePoster Hall) -  Aug 9, 2021 - Abstract #IASLCWCLC2021IASLC_WCLC_932;    
    P3
    Treatment comparison Lorlatinib vs: Studies PFS HR (95% CrI) Alectinib (600 mg) ALEX, ALESIA* 0.61 (0.38 to 0.99) Alectinib (300 mg) J-ALEX* 0.82 (0.36 to 1.85) Brigatinib ALTA-1L 0.57 (0.34 to 0.95) Ceritinib (750 mg) ASCEND-4, ASCEND-8 0.22 (0.13 to 0.37) Ceritinib (450 mg) ASCEND-8 0.31 (0.15 to 0.66) Ceritinib (600 mg) ASCEND-8 0.25 (0.12 to 0.54) Crizotinib CROWN, ALEX, ALESIA*, J-ALEX*, ALTA-1L, ASCEND-4, ASCEND-8, PROFILE 1014, PROFILE 1029*, eXalt3 0.28 (0.19 to 0.41) Ensartinib eXalt3 0.55 (0.32 to 0.93) Chemotherapy ASCEND-4, PROFILE 1014, PROFILE 1029* 0.12 (0.08 to 0.19) Key: CrI, credible interval; HR hazard ratio; PFS, progression-free survival Notes: *Study in Asian population only Conclusion For PFS, lorlatinib reduced the hazard of progression or death compared to all other treatments based on analyses conducted using all studies when comparing to all studies. This NMA suggest that lorlatinib is an effective first line treatment for ALK+ NSCLC patients when compared to other next-generation ALK TKIs.
  • ||||||||||  ensartinib (X-396) / Xcovery
    Clinical, Journal:  Pharmacology and Clinical Evaluation of Ensartinib Hydrochloride Capsule (Pubmed Central) -  Jul 21, 2021   
    Several phase I to III clinical trials included both healthy volunteers and NSCLC patients have been conducted both in China and abroad. In this review, we briefly summarized the results of these trials, and preliminary efficacy, safety, pharmacology and pharmacokinetics/pharmacodynamics of ensartinib were discussed.
  • ||||||||||  [VIRTUAL] Circulating tumor DNA to investigate resistance mechanism and clone evolution of ALK TKI treated lung adenocarcinoma. () -  Apr 28, 2021 - Abstract #ASCO2021ASCO_818;    
    Genotyping of sequential post-progression plasma specimens reveals that treatment with sequential first-, second-, and third-generation ALK inhibitors can accelerate the accumulation of ALK resistance mutations and may lead to treatment-refractory compound ALK mutations . The selection for optimal first-line TKI is very important to achieve a more efficacious long-term strategy and prevent the emergence of on-target resistance.
  • ||||||||||  Ensacove (ensartinib) / Xcovery
    Trial completion date, Trial primary completion date:  eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients (clinicaltrials.gov) -  Jan 29, 2021   
    P3,  N=290, Active, not recruiting, 
    This analysis was limited by the retrospective nature of the study, small numbers within groups analyzed, and heterogeneity between groups. Trial completion date: Mar 2021 --> Dec 2021 | Trial primary completion date: Mar 2021 --> Dec 2021
  • ||||||||||  Ensacove (ensartinib) / Xcovery
    Trial completion date, Trial primary completion date:  Treating Patients With Melanoma and ALK Alterations With Ensartinib (clinicaltrials.gov) -  Jan 26, 2021   
    P2,  N=18, Active, not recruiting, 
    Trial completion date: Mar 2021 --> Dec 2021 | Trial primary completion date: Mar 2021 --> Dec 2021 Trial completion date: Jan 2021 --> Jan 2022 | Trial primary completion date: Jan 2021 --> Jan 2022
  • ||||||||||  Review, Journal:  How to select the best upfront therapy for metastatic disease? Focus on ALK-rearranged non-small cell lung cancer (NSCLC). (Pubmed Central) -  Jan 26, 2021   
    Ceritinib, another second-generation ALK inhibitor has been shown to be superior to chemotherapy in ALK-rearranged disease with good CNS activity...Lorlatinib, a third-generation ALK inhibitor, has demonstrated activity in the treatment naïve setting and in resistance to crizotinib and second-generation ALK inhibitors...Another new ALK inhibitor, ensartinib, has demonstrated efficacy in the first-line setting and in alectinib refractory disease. Additional studies are underway examining mechanisms of resistance and best treatment options post resistance.
  • ||||||||||  Review, Journal:  The Emerging Therapeutic Landscape of ALK Inhibitors in Non-Small Cell Lung Cancer. (Pubmed Central) -  Dec 30, 2020   
    The discovery of the EML4-ALK fusion gene in a limited subset of patients affected by NSCLC and the subsequent clinical development of crizotinib in 2011 has been an impressive milestone in lung cancer research...Afterward, modern tyrosine kinase inhibitors (TKIs), such as ceritinib, alectinib, brigatinib, and lorlatinib, have been approved by the Food and Drug Administration (FDA) for the management of anaplastic lymphoma kinase (ALK)-positive NSCLCs...In this review, we provide a comprehensive overview of the state-of-the-art targeted therapy options in ALK-positive NSCLCs. Resistance, potential therapeutic strategies to overcome drug resistance, and future perspectives for this subset of patients are critically analyzed and summarized.