Zykadia (ceritinib) / Novartis 
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 20 Diseases   19 Trials   19 Trials   1670 News 


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  • ||||||||||  Lorbrena (lorlatinib) / Pfizer, Avastin (bevacizumab) / Roche, Alecensa (alectinib) / Roche
    [VIRTUAL] Therapeutic effectiveness of Lorlatinib After Alectinib in Japanese Patients With ALK - Positive NSCLC in Real - World (ePoster Hall) -  Aug 9, 2021 - Abstract #IASLCWCLC2021IASLC_WCLC_1048;    
    Introduction Three anaplastic lymphoma kinase (ALK)-TKIs (crizotinib, alectinib and ceritinib) are available as 1st line setting in clinical practice in Japan...Alectinib, brigatinib and ceritinib are also recommended in the guideline...Results From the MDV data, 319 patients were identified as who received alectinib and with prescription order for an ALK-TKI (lorlatinib or ceritinib) or chemotherapy (pemetrexed(PEM) or PEM+ cisplatin(CDDP) or bevacizumab(BEV)+PEM+CDDP) directly after alectinib treatment...About half of the patients who were prescribed alectinib were prescribed lorlatinib as the next treatment following alectinib. The median duration of lorlatinib treatment in patients with ALK+NSCLC as the next treatment for alectinib was around 5 months.
  • ||||||||||  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.
  • ||||||||||  Zykadia (ceritinib) / Novartis, Mekinist (trametinib) / Novartis
    [VIRTUAL] A Phase IA Study of Ceritinib + Trametinib in Patients With Advanced ALK - or ROS1 - Rearranged NSCLC: Preliminary Results (ePoster Hall) -  Aug 9, 2021 - Abstract #IASLCWCLC2021IASLC_WCLC_832;    
    P1/2
    The ORR of 22% in a heavily pre-treated patient population suggests that the approach of targeting both ALK and MEK may be an effective therapeutic strategy in a subset of patients who have progressed on prior ALK-targeted monotherapies. Further evaluation of biomarkers of response and resistance are planned as is enrollment at dose level 3, in order to determine the RP2D.
  • ||||||||||  Review, Journal:  Anaplastic Lymphoma Kinase Fusion: A Review of Therapeutic Drugs and Treatment Strategies. (Pubmed Central) -  Jul 15, 2021   
    Therefore, it is necessary to develop next-generation treatment strategies, such as the use of next-generation ALK-TKIs for secondary mutations, or combination therapies with ALK-TKIs and other TKIs. In this review, we summarize the development and use of ALK-TKIs, prior pivotal clinical trials, and resistance mechanisms.
  • ||||||||||  Zykadia (ceritinib) / Novartis
    Journal:  The novel ALK inhibitor ZX-29 induces apoptosis through inhibiting ALK and inducing ROS-mediated endoplasmic reticulum stress in Karpas299 cells. (Pubmed Central) -  Jul 15, 2021   
    We demonstrated that ZX-29 decreased Karpas299 cells growth and had better cytotoxicity than ceritinib, which was mediated through downregulating the expression of ALK and related proteins, inducing cell cycle arrest, and promoting cell apoptosis...Taken together, ZX-29 inhibited Karpas299 cell proliferation and induced apoptosis through inhibiting ALK and its downstream protein expression and inducing ROS-mediated ERS. Therefore, our results provide evidence for a novel antitumor candidate for the further investigation.
  • ||||||||||  Zykadia (ceritinib) / Novartis, Mekinist (trametinib) / Novartis, BeiGene
    Trial completion date, Trial primary completion date, Metastases:  Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) -  Jul 15, 2021   
    P1/2,  N=69, Recruiting, 
    Therefore, our results provide evidence for a novel antitumor candidate for the further investigation. Trial completion date: Jun 2022 --> Dec 2029 | Trial primary completion date: Jun 2021 --> Dec 2029
  • ||||||||||  Journal:  Generative network complex for the automated generation of druglike molecules. (Pubmed Central) -  Jun 22, 2021   
    To further validate the reliability of the predictions, these molecules are reevaluated and screened by independent 2D fingerprint-based predictors to come up with a few hundreds of new drug candidates. As a demonstration, we apply our GNC to generate a large number of new BACE1 inhibitors, as well as thousands of novel alternative drug candidates for eight existing market drugs, including Ceritinib, Ribociclib, Acalabrutinib, Idelalisib, Dabrafenib, Macimorelin, Enzalutamide, and Panobinostat.
  • ||||||||||  Zykadia (ceritinib) / Novartis
    Ceritinib 450 (Twitter) -  Jun 11, 2021   
  • ||||||||||  [VIRTUAL] Research Advances Shaping the Current and Future Treatment of NSCLC with ALK and ROS1 Rearrangements () -  Jun 5, 2021 - Abstract #ASCO2021ASCO_5879;    
    Healthcare costs and resource utilization were significantly higher for patients with ALK + NSCLC with BM versus no BM. Current role of circulating DNA (ctDNA) sequencing, next-generation sequencing, fluorescence in situ hybridization (FISH) and immunohistochemistry testing platforms in the detection of actionable driver mutations and prediction of response to treatment Design, entry criteria and key efficacy and safety findings from the Phase III CROWN trial leading to the recent FDA approval of lorlatinib as first-line therapy for patients with ALK-positive advanced NSCLC; integration into current clinical management Similarities and differences in the efficacy and safety outcomes with first-line alectinib, brigatinib, ceritinib and lorlatinib for patients with metastatic NSCLC with an ALK rearrangement; optimal upfront regimen Assessment, frequency and spectrum of resistance mutations documented in patients with disease progression on an ALK inhibitor in the first-line setting; role of repeat testing and implications for subsequent therapeutic decision-making Pooled efficacy and safety findings supporting the FDA approval of entrectinib in ROS1- positive metastatic NSCLC; intracranial response rates in patients with CNS involvement Optimal approach to the management of adverse events (eg, cardiac, CNS and ocular toxicities) associated with entrectinib Current approach to therapeutic sequencing of available agents and regimens for patients with ALK- or ROS1-positive NSCLC Mechanism of action of repotrectinib and preliminary results from the cohort of patients with advanced NSCLC in the ongoing Phase I/II TRIDENT-1 trial evaluating repotrectinib for patients with advanced solid tumors harboring ALK, ROS1 or NTRK rearrangements; potential clinical role Comparison of the mechanisms of action of repotrectinib and other approved or promising investigational tyrosine kinase inhibitors targeting ALK and/or ROS1 in the management of NSCLC Rationale for the ongoing Phase I/II trial of ceritinib in combination with trametinib for patients with advanced ALK-positive NSCLC Ongoing and planned clinical trials investigating novel strategies (eg, ALBATROS) for patients with advanced NSCLC harboring ALK rearrangements or ROS1 fusions after the failure of first-line tyrosine kinase inhibitor
  • ||||||||||  Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis, Alunbrig (brigatinib) / Takeda
    Journal:  Remarkable Response to Ceritinib and Brigatinib in an Anaplastic Lymphoma Kinase-Rearranged Anaplastic Thyroid Carcinoma previously treated with Crizotinib. (Pubmed Central) -  Jun 5, 2021   
    Current role of circulating DNA (ctDNA) sequencing, next-generation sequencing, fluorescence in situ hybridization (FISH) and immunohistochemistry testing platforms in the detection of actionable driver mutations and prediction of response to treatment Design, entry criteria and key efficacy and safety findings from the Phase III CROWN trial leading to the recent FDA approval of lorlatinib as first-line therapy for patients with ALK-positive advanced NSCLC; integration into current clinical management Similarities and differences in the efficacy and safety outcomes with first-line alectinib, brigatinib, ceritinib and lorlatinib for patients with metastatic NSCLC with an ALK rearrangement; optimal upfront regimen Assessment, frequency and spectrum of resistance mutations documented in patients with disease progression on an ALK inhibitor in the first-line setting; role of repeat testing and implications for subsequent therapeutic decision-making Pooled efficacy and safety findings supporting the FDA approval of entrectinib in ROS1- positive metastatic NSCLC; intracranial response rates in patients with CNS involvement Optimal approach to the management of adverse events (eg, cardiac, CNS and ocular toxicities) associated with entrectinib Current approach to therapeutic sequencing of available agents and regimens for patients with ALK- or ROS1-positive NSCLC Mechanism of action of repotrectinib and preliminary results from the cohort of patients with advanced NSCLC in the ongoing Phase I/II TRIDENT-1 trial evaluating repotrectinib for patients with advanced solid tumors harboring ALK, ROS1 or NTRK rearrangements; potential clinical role Comparison of the mechanisms of action of repotrectinib and other approved or promising investigational tyrosine kinase inhibitors targeting ALK and/or ROS1 in the management of NSCLC Rationale for the ongoing Phase I/II trial of ceritinib in combination with trametinib for patients with advanced ALK-positive NSCLC Ongoing and planned clinical trials investigating novel strategies (eg, ALBATROS) for patients with advanced NSCLC harboring ALK rearrangements or ROS1 fusions after the failure of first-line tyrosine kinase inhibitor is not required.