- |||||||||| Review, Journal, PD(L)-1 Biomarker, IO biomarker: Treatment of Brain Metastases of Non-Small Cell Lung Carcinoma. (Pubmed Central) - Mar 30, 2021
The I117N resistance mutation in patients with the ALK mutation treated with alectinib is overcome by ceritinib...This therapeutic option blocks the PD-1 receptor on the surface of T or B lymphocytes or PD-L1 located on cancer cells with an applicable antibody. Based on clinical trials, pembrolizumab and all antibodies are included in the treatment of non-small cell lung carcinoma with CNS metastases.
- |||||||||| Zykadia (ceritinib) / Novartis
Journal: Targeting Cysteine Located Outside the Active Site: An Effective Strategy for Covalent ALKi Design. (Pubmed Central) - Mar 24, 2021 In addition, the molecule showed significant improvement of anticancer activities and potential antidrug resistant activity compared with Ceritinib, demonstrating the covalent inhibitor of ALK can be a promising drug candidate for the treatment of NSCLC. This work may provide a novel perspective on the design of covalent inhibitors.
- |||||||||| PK/PD data, Review, Journal: Pharmacokinetic-Based Drug-Drug Interactions with Anaplastic Lymphoma Kinase Inhibitors: A Review. (Pubmed Central) - Mar 16, 2021
These factors can result in increased risks for serious adverse events or can lead to reduced therapeutic effects of ALK-TKIs. This review characterizes and summarizes the pharmacokinetic parameters and drug--drug interactions associated with ALK-TKIs to provide specific recommendations for oncologists and clinical pharmacists when prescribing ALK-TKIs.
- |||||||||| Trial completion date, Trial primary completion date, Metastases: MatchMel: Molecular Profiling and Matched Targeted Therapy for Patients With Metastatic Melanoma (clinicaltrials.gov) - Mar 9, 2021
P2, N=1000, Not yet recruiting, In conclusion, NUV-655 (NVL-655) offers a preclinical profile that addresses a medical need for ALK-positive NSCLC patients; it is a brain-penetrant and TRKB-sparing small-molecule inhibitor of ALK with activity against the solvent front drug-resistance mutations G1202R, G1202R/L1196M, and G1202R/G1269A. Trial completion date: Apr 2023 --> Dec 2028 | Trial primary completion date: Apr 2023 --> May 2027
- |||||||||| Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis, Alecensa (alectinib) / Roche
[VIRTUAL] Predictors of treatment response in ALK-positive metastatic non-small cell lung cancer (ePoster Display) - Feb 24, 2021 - Abstract #ELCC2021ELCC_370; Also, we found the cut-off level of ALK positivity ratio in tumor cells for the response was 33% (p = 0.002, AUC:0.740, sensitivity 57.5%, specificity 78.3%).Conclusions In this study, we determined the real-life efficiency of ALK inhibitors in patients with ALK-positive NSCLC. We found that the high ALK positivity ratio, female gender, and having under three metastatic sites were positive predictive factors of ALK inhibitors’ response
- |||||||||| Clinical, Journal: Clinical consequences of resistance to ALK inhibitors in non-small cell lung cancer. (Pubmed Central) - Feb 20, 2021
The third-generation inhibitor lorlatininb is approved for patients who have developed resistance to any ALK inhibitor.Areas covered: In this review, an unstructured search in Pubmed and SCOPUS was conducted. We summarized the mechanisms of resistance to ALK inhibitors and its consequences in the treatment-decision making in advanced or metastatic NSCLC after failure to a first-line ALK inhibitor.Expert opinion: Currently, there are a growing number of options of therapeutic agents against ALK+ NSCLC (approved and in development); however, adequate selection and sequencing of agents is crucial to deal with the tumor evolution.
- |||||||||| 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.
- |||||||||| Zykadia (ceritinib) / Novartis, Opdivo (nivolumab) / Ono Pharma, BMS
Clinical, P1 data, Journal, PD(L)-1 Biomarker, IO biomarker: Ceritinib plus nivolumab in patients with advanced ALK-rearranged non-small-cell lung cancer: results of an open-label, multicenter, phase 1B study: Ceritinib plus nivolumab in ALK-rearranged NSCLC. (Pubmed Central) - Jan 8, 2021 Ceritinib plus nivolumab has activity; ORR appears to correlate with PD-L1 at baseline. Toxicity, especially rash, is more common than with either single agent.
- |||||||||| 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.
- |||||||||| Lorbrena (lorlatinib) / Pfizer, Zykadia (ceritinib) / Novartis, Alunbrig (brigatinib) / Takeda
[VIRTUAL] Real-World First Line Targeted Therapy Duration Following ctDNA Testing in Advanced Non-Small Cell Lung Cancer (ePoster Hall) - Dec 17, 2020 - Abstract #IASLCWCLC2020IASLC_WCLC_1626; In this largest real-world series of similar subjects to date, duration ofEGFR and ALK targeted therapy was comparable in claims data to duration of treatment based on tissue molecular testing. These data demonstrate that first line targeted aNSCLC treatment based on a well-validated, comprehensive ctDNA test (Guardant360) has similar outcomes to tissue guided first line targeted therapy.
- |||||||||| Zykadia (ceritinib) / Novartis, CI-1040 / Pfizer
Preclinical, Journal: A mass spectrometry-based proteome map of drug action in lung cancer cell lines. (Pubmed Central) - Dec 16, 2020 Aggregating drug response across cell lines also revealed that one-quarter of compounds modulated the abundance of one of their known protein targets. Finally, the proteomic data led us to discover that inhibition of mitochondrial function is an off-target mechanism of the MAP2K1/2 inhibitor PD184352 and that the ALK inhibitor ceritinib modulates autophagy.
- |||||||||| Zykadia (ceritinib) / Novartis
Trial completion: Preoperative Ceritinib (LDK378) in Glioblastoma Multiforme and CNS Metastasis (clinicaltrials.gov) - Dec 11, 2020 P1, N=10, Completed, Finally, the proteomic data led us to discover that inhibition of mitochondrial function is an off-target mechanism of the MAP2K1/2 inhibitor PD184352 and that the ALK inhibitor ceritinib modulates autophagy. Active, not recruiting --> Completed
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