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


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  • ||||||||||  Biomarker, Trial completion date, Trial primary completion date:  NRG-LU003: Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer (clinicaltrials.gov) -  Dec 7, 2022   
    P2,  N=660, Active, not recruiting, 
    In summary, our results demonstrate that targeting the MDK/PTN-ALK axis with clinically-approved inhibitors impairs in vivo tumorigenicity and chemoresistance in PDAC suggesting a new treatment approach to improve the long-term survival of PDAC patients. Trial completion date: Dec 2025 --> May 2023 | Trial primary completion date: Dec 2025 --> May 2023
  • ||||||||||  Journal:  Prediction of Resistance Mutations Against Upcoming Anaplastic Lymphoma Kinase Inhibitors. (Pubmed Central) -  Oct 7, 2022   
    When this system was applied to repotrectinib and ensartinib, the results suggested that these drugs can be used for the second-line treatment of ALK-positive NSCLC. Predicting resistance mutations against TKIs will provide useful information to aid in the development of effective therapeutic strategies.
  • ||||||||||  Ensacove (ensartinib) / Xcovery, Alecensa (alectinib) / Roche
    Journal:  A Case of Advanced Lung Squamous Cell Carcinoma with CLIP1-ALK Fusion Gene (Pubmed Central) -  Oct 6, 2022   
    Aletinib was effective for this patient but the patients died on September 30, 2021. This is a report of lung squamous cell carcinoma patients with CLIP1-ALK fusion gene treated with ALK inhibitors..
  • ||||||||||  Review, Journal:  Anti-Angiogenic Therapy in ALK Rearranged Non-Small Cell Lung Cancer (NSCLC). (Pubmed Central) -  Sep 3, 2022   
    The role for anti-angiogenic therapy in ALK rearranged NSCLC, however, remains to be elucidated. This review will discuss the pre-clinical rationale, clinical trial evidence to date, and future directions to evaluate anti-angiogenic therapy in ALK rearranged NSCLC.
  • ||||||||||  Alunbrig (brigatinib) / Takeda
    Journal:  Strengths and pitfalls of brigatinib in non-small cell lung cancer patients' management. (Pubmed Central) -  May 24, 2022   
    Through a spurious exercise of an indirect comparison with other available 2G ALKi, we tent to summarize the required knowledge to properly choose the best drug at the right time. Furthermore, we reviewed available data on molecular resistance mechanisms and putative therapeutic applications in other contexts, such as ROS1+ NSCLC patients or EGFR+ ones progressing to osimertinib.
  • ||||||||||  Ensacove (ensartinib) / Xcovery
    Journal:  Expert consensus on ensartinib in the treatment of anaplastic lymphoma kinase-positive non-small cell lung cancer (Pubmed Central) -  Apr 29, 2022   
    In order to facilitate clinical application and provide patients with more treatment options, under the guidance of the Committee of Cancer Rehabilitation and Palliative Care of China Anti-Cancer Association, this article collects and summarizes the common adverse reactions of ensartinib. Based on the clinical practice, a clear adverse classification and specific treatment plan are formulated, in order to provide a corresponding reference for clinicians to make more comprehensive clinical decisions.
  • ||||||||||  Review, Journal:  Targeting ALK Rearrangements in NSCLC: Current State of the Art. (Pubmed Central) -  Apr 26, 2022   
    Recently, a potent, third-generation ALK inhibitor, lorlatinib, has been approved by the Food and Drug Administration (FDA) for the first-line treatment of ALK-positive (ALK+) NSCLC...Efforts have also been undertaken to develop further generations of ALK inhibitors. This review will summarize the current situation of targeting the ALK signaling pathway.
  • ||||||||||  Ensacove (ensartinib) / Xcovery, Lorbrena (lorlatinib) / Pfizer, Alecensa (alectinib) / Roche
    Clinical, Journal:  First-line treatment of advanced non-small cell lung cancer with ALK rearrangement: State of the art and future development. (Pubmed Central) -  Apr 7, 2022   
    Expert Opinion Alectinib should currently be regarded as the standard of care for the first-line treatment of ALK+ NSCLC, considering its superior efficacy and safety profile. Regarding developing agents, lorlatinib and ensartinib appear to be the most promising ones, even though the data from their trials are still immature.
  • ||||||||||  repotrectinib (TPX-0005) / Turning Point Therapeutics, ZAI Lab
    Journal:  Translational Strategies for Repotrectinib in Neuroblastoma. (Pubmed Central) -  Mar 26, 2022   
    Repotrectinib plus chemotherapy was superior to chemotherapy alone in ALK-mutant and ALK wild-type PDX models. These results demonstrate that repotrectinib has anti-tumor activity in genotypically diverse neuroblastoma models, and that combination of a multi-kinase inhibitor with chemotherapy may be a promising treatment paradigm for translation to the clinic.
  • ||||||||||  Ensacove (ensartinib) / Xcovery
    Clinical, PK/PD data, Journal:  Effects of food on the pharmacokinetics of ensartinib in healthy Chinese subjects. (Pubmed Central) -  Mar 26, 2022   
    The final model included food and age as covariates on apparent distribution and apparent clearance. Based on the final PopPK model, food was identified as a significant covariate for apparent clearance, apparent volume of distribution, and absorption rate constant, consistent with the results of non-compartmental pharmacokinetic analysis.
  • ||||||||||  Ensacove (ensartinib) / Xcovery, Xalkori (crizotinib) / Pfizer
    Review, Journal, IO biomarker:  Review of Therapeutic Strategies for Anaplastic Lymphoma Kinase-Rearranged Non-Small Cell Lung Cancer. (Pubmed Central) -  Mar 11, 2022   
    Following the development of crizotinib, the first ALK-TKI, patient prognosis has been greatly improved...In addition, clinical trials of the novel TKI, ensartinib, and fourth-generation ALK-TKI for compound ALK mutation are ongoing...Studies on tissue and liquid biopsy have been reported and are expected to be useful tools for identifying resistance mechanisms. The purpose of this manuscript is to provide information on the recent clinical trials of ALK-TKIs, angiogenesis inhibitors, immune checkpoint inhibitors, and chemotherapy to describe tissue and liquid biopsy as a method to investigate the mechanisms of resistance against ALK-TKIs and suggest a proposed treatment algorithm.
  • ||||||||||  Ensacove (ensartinib) / Xcovery
    Antitumor effects of ensartinib in non-small cell lung cancer harboring MET exon 14-skipping mutations (Section 32) -  Mar 9, 2022 - Abstract #AACR2022AACR_5853;    
    These results provide the first evidence that ensartinib exhibits both preclinical and clinical antitumor activity against MET exon 14 skipping mutations with the potential of strong intracranial efficacy and warrant further evaluation in a planned phase II study thus providing more options to patients with MET exon 14 skipping mutations. Updated data including duration of response, PFS and and OS will be provided at the time of the presentation with additional few months of follow up.
  • ||||||||||  cisplatin / Generic mfg., docetaxel / Generic mfg.
    Clinical, Journal:  Whole-Process Management of Treatment of Advanced ALK Positive Non-small Cell Lung Cancer: A Case Report (Pubmed Central) -  Feb 4, 2022   
    Next-generation inhibitors have not been compared to each other, and it is unknown which should be used first and what subsequent treatment sequence is optimal. The advanced ALK fusion positive lung adenocarcinoma patients, though the first-line and the second-line chemotherapy, and the follwing application of ALK-TKI treatment, has procured a total OS has reached 68 months, and the current follow-up is good.
  • ||||||||||  Journal:  Recommendations from Experts in the Management of Adverse Reactions to ALK Inhibitors (2021 Version) (Pubmed Central) -  Feb 3, 2022   
    However, there was no guidance for the management of ALKi adverse reactions. Therefore, this "Recommendations from experts in the management of adverse reactions to ALK inhibitors (2021 version)" has been summarized, led by Lung Cancer Professional Committee of Sichuan Cancer Society and Sichuan Medical Quality Control Center for Tumor Diseases, to provide practical and feasible strategies for clinical ALKi management specification of adverse reactions..
  • ||||||||||  Ensacove (ensartinib) / Xcovery
    Trial completion date:  eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients (clinicaltrials.gov) -  Jan 30, 2022   
    P3,  N=290, Active, not recruiting, 
    Therefore, this "Recommendations from experts in the management of adverse reactions to ALK inhibitors (2021 version)" has been summarized, led by Lung Cancer Professional Committee of Sichuan Cancer Society and Sichuan Medical Quality Control Center for Tumor Diseases, to provide practical and feasible strategies for clinical ALKi management specification of adverse reactions.. Trial completion date: Dec 2021 --> Dec 2022