Zykadia (ceritinib) / Novartis 
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 20 Diseases   18 Trials   18 Trials   1690 News 


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  • ||||||||||  Clinical, Review, Journal:  Safety and efficacy of anaplastic lymphoma kinase tyrosine kinase inhibitors in non‑small cell lung cancer (Review). (Pubmed Central) -  Sep 1, 2021   
    A series of studies have indicated that ALK‑TKI agents as the first‑line treatment, including crizotinib, ceritinib, brigatinib, alectinib and entrectinib, can benefit patients with ALK‑positive NSCLC...This study reviews the pharmacodynamics, efficacy and safety of ALK‑TKI agents in order to summarize these effects as well as the relevant management strategies. It is worth emphasizing that the frequency and severity of an adverse effect often varies across different trials.
  • ||||||||||  Zykadia (ceritinib) / Novartis
    Ceritinib (Twitter) -  Aug 27, 2021   
  • ||||||||||  [VIRTUAL] Systemic therapy first (Channel 2) -  Aug 20, 2021 - Abstract #EANO2021EANO_208;    
    Particularly in HER2 positive disease, certain agents (tucatinib, neratinib and ponatinib) have shown impressive efficacy in the central nervous system. In summary, several common solid tumors with a targetable mutation and CNS metastases can be approached pharmacologically in order to avoid or delay the use of radiotherapy and it's side effects.
  • ||||||||||  Zykadia (ceritinib) / Novartis, Kisqali (ribociclib) / Novartis, NN1213 / Novo Nordisk
    Trial completion date, Trial primary completion date:  NEPENTHE: Next Generation Personalized Neuroblastoma Therapy (clinicaltrials.gov) -  Aug 19, 2021   
    P1,  N=131, Recruiting, 
    In summary, several common solid tumors with a targetable mutation and CNS metastases can be approached pharmacologically in order to avoid or delay the use of radiotherapy and it's side effects. Trial completion date: May 2026 --> Jun 2024 | Trial primary completion date: Jul 2021 --> Jun 2023
  • ||||||||||  Zykadia (ceritinib) / Novartis, Mekinist (trametinib) / Novartis, BeiGene
    Trial completion date, Trial primary completion date:  Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma (clinicaltrials.gov) -  Aug 18, 2021   
    P1,  N=27, Recruiting, 
    Trial completion date: May 2026 --> Jun 2024 | Trial primary completion date: Jul 2021 --> Jun 2023 Trial completion date: Jun 2022 --> Jun 2023 | Trial primary completion date: Jun 2021 --> Jun 2022
  • ||||||||||  [VIRTUAL] Real - World Clinically - Relevant Toxicities of ALK TKIs in a Cohort of Patients With Advanced/Metastatic ALK+ NSCLC (ePoster Hall) -  Aug 9, 2021 - Abstract #IASLCWCLC2021IASLC_WCLC_1063;    
    Median overall survival (OS) in patients with at least one treatment modification trended, but was not significantly different from patients without any treatment modification (47.0 vs 57.8 months, p=0.09). Conclusion In a real-world cohort, treatment modifications on ALK-TKI were needed frequently, even with the newer generation of ALK-TKIs, highlighting the importance of availability of different ALK-TKIs for patients experiencing AEs to ensure tolerable targeted treatment.
  • ||||||||||  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