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- | Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
Journal: Attenuated isolated 3' signal: A highly challenging therapy relevant ALK FISH pattern in NSCLC. (Pubmed Central) - Apr 13, 2021
Our results emphasize the importance of extensive exploration of the genetic background of any unexpected FISH finding to avoid false diagnosis. This enables clinicians to indicate the adequate therapy with higher efficiency for patients suffering from NSCLC.
- Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
[VIRTUAL] Healthcare Resource Utilization and Costs Among Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Anaplastic Lymphoma Kinase (ALK) Inhibitors () - Apr 12, 2021 - Abstract #ISPOR2021ISPOR_423;
In this study, patients receiving alectinib as the first ALKi had approximately 20% lower mean adjusted total cost of care compared with patients receiving crizotinib. This real-world economic evidence supplements clinical benefits from the ALEX study, supporting the use of alectinib as the first ALKi in ALK+ NSCLC patients.
- Xalkori (crizotinib) / Pfizer, Alunbrig (brigatinib) / Takeda, Alecensa (alectinib) / Roche
[VIRTUAL] Brigatinib Compared with Crizotinib and Alectinib in Patients with ALK-Positive Non-Small Cell Lung Cancer (NSCLC) with Brain Metastases at Diagnosis- A Cost-Effectiveness Analysis from the Perspective of the Brazilian Private Health Care S ... () - Apr 12, 2021 - Abstract #ISPOR2021ISPOR_421;
This can be seen as an opportunity to enhance local health care sustainability, with the potential to improve the prognosis of ALK+ NSCLC even in patients with brain metastases at diagnosis. This study was funded by Takeda Farmacêutica Brasil.
- | Alecensa (alectinib) / Roche
Enrollment open, Trial completion date, Trial primary completion date: Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns (clinicaltrials.gov) - Apr 8, 2021
P=N/A, N=1, Recruiting, Sponsor: Pfizer
This study was funded by Takeda Farmacêutica Brasil. Active, not recruiting --> Recruiting | Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021
- | Alecensa (alectinib) / Roche
New P2 trial, Metastases: Cancer Molecular Screening and Therapeutics (MoST) Program and ASPiRATION subprogram, Addendum 14 (EUDRACT) - Apr 5, 2021
P2, N=16, Not yet recruiting, Sponsor: University of Sydney
- |||| Alecensa (alectinib) / Roche
Clinical: First case of pregnancy on ALECTINIB, taken care of in Milan by wonderful MDT. Very delicate issue for young patients with oncogen-addicted NSCLC @marinagarassino @GarassinoMarina @fedrophd @ all authors!!! https://t.co/6MHxkfaodJ (Twitter) - Mar 30, 2021
- || Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis, Alecensa (alectinib) / Roche
Clinical, Journal: A case of primary pulmonary atypical carcinoid with EML4-ALK rearrangement. (Pubmed Central) - Mar 30, 2021
This article reviewed the clinical significance and drug resistance mechanism of ALK rearrangement in lung cancer. We also discussed recent and ongoing researches and applications of ALK-tyrosine kinase inhibitors (ALK-TKIs).
- || 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.
- ||||| Alecensa (alectinib) / Roche
Clinical: This is a wonderful scientific and human story of a young women with #ALK #NSCLC who bravely deliver a normal on #alectinib. Life continues also with cancer and we learnt to preserve and support parient’s choices. ❤️ (Twitter) - Mar 30, 2021
- ||||| Alecensa (alectinib) / Roche
Clinical: First Case Report of Pregnancy on Alectinib in a Woman With Metastatic ALK-Rearranged Lung Cancer: A Case Report - Journal of Thoracic Oncology #lcsm https://t.co/a0ik0Fva3j (Twitter) - Mar 30, 2021
- ||||| Alecensa (alectinib) / Roche
Clinical: #OncoAlert This report in @JTOonline describes pregnancy while the mother was taking alectinib for #ALK NSCLC. Very little data in this setting - appreciate the patients' generosity in sharing results. Alectinib levels 14x higher in maternal blood. #LCSM https://t.co/Jx0ca7mk0v (Twitter) - Mar 29, 2021
- | New P2 trial, Metastases: IMPRESS-N: Improving Public Cancer Care by Implementing Precision Medicine in Norway (clinicaltrials.gov) - Mar 25, 2021
P2, N=1000, Not yet recruiting, Sponsor: Oslo University Hospital
- |||| Alecensa (alectinib) / Roche
Clinical, Next-generation sequencing: There will probably never even enough patient to have an adjuvant trial using alectinib. I am not too worried about adjuvant alectinib, however, I have seen more pushes in community practices to get early stage lung cancer to get NGS tests, it is waste of money. (Twitter) - Mar 22, 2021
- |||| Alecensa (alectinib) / Roche
Clinical: I'm not yet convinced every pt should get a >$3K panel because "it'd be nice to know", & which is prone to lead ppl to be tempted to do adjuvant osi or alectinib, etc., even for a <2 cm node-neg cancer. I'm already seeing wild extrapolation of molecular data in this setting. (Twitter) - Mar 22, 2021
- ||| Alecensa (alectinib) / Roche
Clinical: Thank you @Aiims1742 the patient did respond magically to Alectinib in December only to have progression at first PET in 3 months - repeat biopsy showing MET amp as the ?resistant pathway (Twitter) - Mar 18, 2021
- ||| Lorbrena (lorlatinib) / Pfizer, Alecensa (alectinib) / Roche
Rx choice? #PrecisionMedicine - Alectinib+Capmat+adotrastu - Lorlatinib+Capmat+adotrastu - chemotherapy alone @Dr_R_Kurzrock @VivekSubbiah @EileenMOReilly @BenWestphalen @pashtoonkasi @skopetz @rachnatshroff @Aiims1742 @SirohiBhawna @oncologician @UmutDisel (Twitter) - Mar 18, 2021
- || 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.
- || Lorbrena (lorlatinib) / Pfizer, Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
Clinical, Preclinical, Journal: BRAF V600E mutation as a novel mechanism of acquired resistance to ALK inhibition in ALK-rearranged lung adenocarcinoma: A case report. (Pubmed Central) - Mar 16, 2021
We present a case of ALK-rearranged lung adenocarcinoma with acquired resistance to ALK inhibition, in which the BRAF V600E mutation is a novel resistance mechanism. This provides evidence that BRAF V600E mutation is one mechanism of ALK-TKI resistance.
- | Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis, Alecensa (alectinib) / Roche
Retrospective data, Journal: Clinical characteristics and risk factors of drug-induced lung injury by ALK tyrosine kinase inhibitors: A single center retrospective analysis. (Pubmed Central) - Mar 12, 2021
This provides evidence that BRAF V600E mutation is one mechanism of ALK-TKI resistance. The same or a different ALK-TKI may be considered as a treatment option after the onset of DILI, based on careful judgment.
- || Xalkori (crizotinib) / Pfizer, Nexavar (sorafenib) / Bayer, Amgen, Alecensa (alectinib) / Roche
Review, Journal: Novel Multitarget Therapies for Lung Cancer and Respiratory Disease. (Pubmed Central) - Mar 12, 2021
Nintedanib is a multiple tyrosine kinase inhibitor that targets FGFR, PDGFR, and VEGFR. In this review, we summarize the mechanisms of action of multitarget therapies and report the results of the latest clinical trials.
- || Clinical, Journal, Real-World Evidence: Longitudinal Health Utilities, Symptoms and Toxicities in Patients with ALK-Rearranged Lung Cancer Treated with Tyrosine Kinase Inhibitors: A Prospective Real-World Assessment. (Pubmed Central) - Mar 12, 2021
There was no significant decrease in HUS when patients with ALK+ disease were treated longitudinally with each TKI, as long as patients were clinically stable. Alectinib, brigatinib, and lorlatinib had the best toxicity profiles and exhibited high mean HUS longitudinally in the real-world setting.
- [VIRTUAL] Activation of YAP1 confers ROS1 inhibitor resistance in ROS1-rearranged lung cancer () - Mar 11, 2021 - Abstract #AACR2021AACR_3701;
Finally, we found that AKT was reactivated with activation of YAP1 and silencing of YAP1 by siRNA suppressed this AKT reactivation. These results suggest that YAP1 may be a potential drug target for ROS1-rearranged lung cancer.
- TPX-0131 / Turning Point Therapeutics
[VIRTUAL] TPX-0131, a potent inhibitor of wild type ALK and a broad spectrum of both single and compound ALK resistance mutations () - Mar 11, 2021 - Abstract #AACR2021AACR_395;
In contrast, lorlatinib (5 mg/kg BID) caused 31% TGI in the G1202R/L1198F model and did not have statistically significant TGI in the G1202R/L1196M model. Taken together, TPX-0131 is a next generation ALK inhibitor that has preclinical potency against WT ALK as well as a broad spectrum of acquired resistance mutations, especially compound mutations, which currently lack any effective ALK inhibitor therapy.
- Lorbrena (lorlatinib) / Pfizer, NVL-655 / Nuvalent
[VIRTUAL] NUV-655 (NVL-655) is a selective, brain-penetrant ALK inhibitor with antitumor activity against the lorlatinib-resistant G1202R/L1196M compound mutation () - Mar 11, 2021 - Abstract #AACR2021AACR_394;
Furthermore, NUV-655 (NVL-655) demonstrated brain penetrance in rodent pharmacokinetic studies. 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.
- | Alecensa (alectinib) / Roche
Journal: Metformin reduces HGF-induced resistance to alectinib via the inhibition of Gab1. (Pubmed Central) - Mar 10, 2021
The antidiabetic drug metformin combined with alectinib overcame alectinib resistance triggered by HGF/MET through disrupting the complex between MET and Gab1, thereby inhibiting Gab1 phosphorylation and the activation of downstream signal transduction pathways. These results suggest that metformin combined with alectinib may be useful for overcoming alectinib resistance induced by the activation of the HGF/MET signalling pathway and improving the efficacy of alectinib.
- || Alecensa (alectinib) / Roche
Clinical, Journal: Two cases of marked red cell anisopoikilocytosis and haemolysis with alectinib, an anaplastic lymphoma kinase inhibitor. (Pubmed Central) - Mar 10, 2021
These results suggest that metformin combined with alectinib may be useful for overcoming alectinib resistance induced by the activation of the HGF/MET signalling pathway and improving the efficacy of alectinib. No abstract available
- | Cotellic (cobimetinib) / Exelixis, Roche, Alecensa (alectinib) / Roche
Trial completion date, Trial primary completion date, Metastases: A Phase IB/II Study of Alectinib Combined With Cobimetinib in Advanced ALK-Rearranged (ALK+) NSCLC (clinicaltrials.gov) - Mar 9, 2021
P1/2, N=31, Recruiting, Sponsor: Massachusetts General Hospital
No abstract available Trial completion date: Nov 2022 --> Nov 2024 | Trial primary completion date: Nov 2021 --> Nov 2022
- | Journal: Overcoming resistance by ALK compound mutation (I1171S + G1269A) after sequential treatment of multiple ALK inhibitors in non-small cell lung cancer. (Pubmed Central) - Mar 9, 2021
ALK compound mutation was found in a clinical sample that was resistant to lorlatinib after sequential ALK-tyrosine kinase inhibitor (TKI) treatment. Ceritinib and brigatinib are potential overcoming drugs against ALK I1171S + G1269A double mutation.
- || Gilotrif (afatinib) / Boehringer Ingelheim, Alecensa (alectinib) / Roche
Same is true for other drugs like afatinib and alectinib (J-ALEX). (Twitter) - Mar 8, 2021
- [VIRTUAL] New Studies of Approved Agents: Crizotinib, Ceritinib, Alectinib, Lorlatinib, Ensartinib - New Data and Resistance Mechanisms () - Mar 6, 2021 - Abstract #IASLCTTLC2021IASLC-TTLC_175;
- [VIRTUAL] New Studies of Approved Agents: Crizotinib, Ceritinib, Alectinib, Lorlatinib, Ensartinib - New Data and Resistance Mechanisms () - Mar 6, 2021 - Abstract #IASLCTTLC2021IASLC-TTLC_172;
- || Alunbrig (brigatinib) / Takeda, Alecensa (alectinib) / Roche
Clinical, Journal, Head-to-Head: Head to head evaluation of second generation ALK inhibitors brigatinib and alectinib as first-line treatment for ALK+ NSCLC using an in silico systems biology-based approach. (Pubmed Central) - Mar 5, 2021
Future investigation involving clinical studies will be needed to confirm these findings. These in silico systems biology-based models could be applied for exploring other unanswered questions.
- ||| Alecensa (alectinib) / Roche
Perhaps start the other way around. Don't start at 100 and scale down, but maybe at 50 and scale up. Im on Alectinib myself and have learned to overcome the muscle fatigue by doing intense workouts, but I can understand that people find it restricting in comparison. (Twitter) - Mar 4, 2021
- |||| Lorbrena (lorlatinib) / Pfizer, Alecensa (alectinib) / Roche
Clinical: ALK patients want sequencing data. What combo will allow us to live the longest. What TKI will you start your newly diagnosed pts. on? Alectinib or Lorlatinib? (Twitter) - Mar 4, 2021
- || Lorbrena (lorlatinib) / Pfizer, Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
And I think that concern about benefit of sequential TKIs is very appropriate. In my mind, 1L lorlatinib needs to give better PFS +/- OS than alectinib followed by lorlatinib at progression. Crizotinib was a far easier comparator to beat than 1L agents routinely used today. (Twitter) - Mar 4, 2021
- ||| Lorbrena (lorlatinib) / Pfizer, Alecensa (alectinib) / Roche
Adverse events: I might be the Lorlatinib unicorn. I have ever side effect but also have a great palliative team to manage it all. I'm on 125mg for my brain & holding stable. I love this drug. Way better than the energy depleting Alectinib. (Twitter) - Mar 4, 2021
- || Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
As a pt. research advocate-I could not agreed more. We need data w/Alectinib now forget Crizotinib. (Twitter) - Mar 4, 2021
- || Lorbrena (lorlatinib) / Pfizer, Alecensa (alectinib) / Roche
In some countries lorlatinib is cheaper than alectinib. (Twitter) - Mar 4, 2021
- | Lorbrena (lorlatinib) / Pfizer, Xospata (gilteritinib) / Astellas
Journal: Gilteritinib overcomes lorlatinib resistance in ALK-rearranged cancer. (Pubmed Central) - Mar 4, 2021
However, the relapsed tumor was markedly shrunk after switching to the gilteritinib in vivo model. In addition, gilteritinib was effective against NTRK-rearranged cancers including entrectinib-resistant NTRK1 G667C-mutant and ROS1 fusion-positive cancer.
- |||| Adverse events: IMO, side effect profile w/lorlatinib more challenging than alectinib or brigatinib, esp for longitudinal use, & not clearly more effective than them, regardless of how it does vs. crizotinib. Plus, using lorlatinib 1L means not having it as potentially effective 2L agent. #LCSM (Twitter) - Mar 3, 2021
- ||||| Lorbrena (lorlatinib) / Pfizer, Alunbrig (brigatinib) / Takeda, Alecensa (alectinib) / Roche
Clinical, FDA event: Nice to have FDA approval here, for me the intracranial ORR and duration of response make lorlatinib 1L a good option for ALK+ CNS+ (alectinib and brigatinib have excellent CNS efficacy as well) (Twitter) - Mar 3, 2021
- Lorbrena (lorlatinib) / Pfizer, Alecensa (alectinib) / Roche
[VIRTUAL] Lorlatinib versus Pemetrexed-based chemotherapy in patients with ALK-rearranged non-small cell lung cancer previously treated with Alectinib () - Mar 2, 2021 - Abstract #JSMO2021JSMO_1197;
- Alunbrig (brigatinib) / Takeda, Alecensa (alectinib) / Roche
[VIRTUAL] Brigatinib activity in alectinib-resistant ALK-positive NSCLC according to ALK plasma mutation status from J-ALTA trial (Track 11) - Mar 2, 2021 - Abstract #JSMO2021JSMO_325;
- Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
[VIRTUAL] Characteristics of central nervous system progression in non-small-cell lung cancer treated with crizotinib or alectinib (Track 14) - Mar 2, 2021 - Abstract #JSMO2021JSMO_117;
- | TAE-684 / Novartis, Scripps Research Institute, Alecensa (alectinib) / Roche
Journal: Binge-Like Ethanol Drinking Activates ALK Signaling and Increases the Expression of STAT3 Target Genes in the Mouse Hippocampus and Prefrontal Cortex. (Pubmed Central) - Mar 2, 2021
We further demonstrated by qPCR that expression of the putative STAT3 genes Nr1h2, Smarcc1, Smarca4, and Gpnmb were increased in either the PFC or HPC after binge-like drinking. Together, these results indicate activation of the ALK-STAT3 signaling pathway in the brain after binge-like ethanol consumption, identify putative novel ethanol-responsive STAT3 target genes, and suggest that STAT3 inhibition may be a potential method to reduce binge drinking in humans.
- || Alecensa (alectinib) / Roche
New P1/2 trial: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors (clinicaltrials.gov) - Feb 28, 2021
P1/2, N=42, Not yet recruiting, Sponsor: Hoffmann-La Roche
- 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
- Alecensa (alectinib) / Roche
[VIRTUAL] Intracranial efficacy of alectinib in ALK-positive NSCLC patients with CNS metastases: A multicenter retrospective study (ePoster Display) - Feb 24, 2021 - Abstract #ELCC2021ELCC_369;
Intracranical time to tumor progression were still not reached with the median follow up of 13.2 months, 16.7 months, 10.4 months in each cohort. Conclusions Our results indicated that Alectinib showed substantial intracranial activity in ALK-positive patients with CNS metastases regardless of their intracranial disease condition or previous ALK-TKI treatment history.
- ||| Lorbrena (lorlatinib) / Pfizer, Xalkori (crizotinib) / Pfizer
Enrollment open, Real-world evidence, Real-world: SEQUIA: Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor Drugs and Their Therapeutic Outcomes Based on Data From National Registers. (clinicaltrials.gov) - Feb 22, 2021
P=N/A, N=500, Recruiting, Sponsor: Pfizer
Conclusions Our results indicated that Alectinib showed substantial intracranial activity in ALK-positive patients with CNS metastases regardless of their intracranial disease condition or previous ALK-TKI treatment history. Not yet recruiting --> Recruiting
- |||||| Alecensa (alectinib) / Roche
New trial, Real-world evidence, Real-world, Metastases: ReAlec: An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib (clinicaltrials.gov) - Feb 20, 2021
P, N=1000, Not yet recruiting, Sponsor: Hoffmann-La Roche