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- || Biomarker, Review, Journal: Biomarker guided treatment in oncogene-driven advanced non-small cell lung cancer in older adults: A Young International Society of Geriatric Oncology Report. (Pubmed Central) - May 8, 2022
Based on currently available data, molecularly-guided therapy for most alterations is safe and efficacious in older adults with oncogene-driven advanced NSCLC. However, for many TKIs, older adult-specific data are lacking, and should be subject of future prospective evaluations.
- ||| Alecensa (alectinib) / Roche
Clinical: Oh my this is SO TIMELY!! I have to get on a Peer to Peer call on Monday to get approval for Alectinib for a patient!! Thank you! (Twitter) - May 7, 2022
- ||| Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
Biomarker, P3 data, Clinical Trial,Phase III, Journal: Circulating Cell-free DNA as a Prognostic Biomarker in Patients with Advanced ALK+ Non-small Cell Lung Cancer in the Global Phase III ALEX Trial. (Pubmed Central) - May 6, 2022
These data suggest that plasma cfDNA concentration may have prognostic value in advanced ALK+ NSCLC. Prospectively designed studies are warranted to investigate this finding.
- Alecensa (alectinib) / Roche
Alectinib-Induced Reversible Acute Kidney Injury (Mini-Orals Hall) - May 5, 2022 - Abstract #ERAEDTA2022ERA_EDTA_921;
Furthermore, the patient recovered from kidney function after drug discontinuation. Frequent monitoring of renal functions is important, as it allows for drug dosage adjustment, which can prevent severe AKI and reduce the morbidity of these frail patients.
- | Xalkori (crizotinib) / Pfizer, Rozlytrek (entrectinib) / Roche, Alecensa (alectinib) / Roche
Journal: ALK Inhibitors in Patients With ALK Fusion-Positive GI Cancers: An International Data Set and a Molecular Case Series. (Pubmed Central) - May 5, 2022
Despite the rarity, ALK rearrangements represent an important therapeutic target in individual pretreated patients with GI solid tumors. Further work providing prospective clinical validation of this target is needed.
- | Lorbrena (lorlatinib) / Pfizer, Alecensa (alectinib) / Roche
Journal: Lorlatinib Versus Pemetrexed-Based Chemotherapy in Patients With ALK-rearranged NSCLC Previously Treated With Alectinib. (Pubmed Central) - May 3, 2022
In patients without CNS metastasis at baseline, the cumulative incidence rate of CNS progression was lower over time in the LOR group compared with the PEM group (p = 0.045), whereas in patients with CNS metastasis at baseline, there were no significant differences in cumulative incidence rate of CNS progression between both groups (p = 0.43). Clinical outcomes of PEM and LOR after failure of alectinib were similar in patients with ALK-positive NSCLC.
- ||| Alecensa (alectinib) / Roche
Journal, Adverse events: Hemolytic anemia following alectinib reported to the U.S. Food and Drug Administration Adverse Event Reporting System. (Pubmed Central) - Apr 30, 2022
Clinical outcomes of PEM and LOR after failure of alectinib were similar in patients with ALK-positive NSCLC. No abstract available
- ||| Alecensa (alectinib) / Roche
Already an established target in NSCLC, #ALK fusions in GI cancers are rare but actionable, seen in this report @JCOPO_ASCO. Small cohort evaluable after ALK TKI therapy (n=12) showed RR 41% and DCR 82%. In GI cancers, mPFS 5m with one > 2y on alectinib. https://t.co/g5PR7HkLbm (Twitter) - Apr 30, 2022
- | 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.
- | Xalkori (crizotinib) / Pfizer, Endostar (recombinant human endostatin) / Simcere, Alecensa (alectinib) / Roche
Journal: Effective treatment in lung adenocarcinoma patient with brain metastases harboring novel CLHC1/RNT4 intergenic region- ALK fusion: A case report. (Pubmed Central) - Apr 28, 2022
In our case, a novel CLHC1/RNT4 intergenic region, ALK fusion, was identified for the first time in a lung adenocarcinoma patient with BM, who benefited from crizotinib and endostar sequential alectinib. Our case highlights the advantages of NGS for fusion detection and provides promising treatment options for NSCLC patients with BM harboring ALK fusions.
- ||| Alecensa (alectinib) / Roche
Wasnt this written by Roche/Genetech the makers of Alectinib ? (Twitter) - Apr 28, 2022
- |||| Zykadia (ceritinib) / Novartis, Alecensa (alectinib) / Roche
Clinical, Real-world evidence: Assessment of Alectinib vs Ceritinib in ALK-Positive NSCLC in Phase 2 Trials and Real-world Data https://t.co/FuAkqEBkWw via @JAMANetworkOpen part of @JAMANetwork (Twitter) - Apr 28, 2022
- Managing cardiotoxicity in metastatic non-small cell lung cancer (NSCLC) patients treated with tyrosine kinase inhibitors (TKIs). () - Apr 28, 2022 - Abstract #ASCO2022ASCO_6307;
The increased rate of hypertension observed may be associated with the high rate of uncontrolled blood pressure at baseline. Low adherence rates to the recommendations provided by prescribing information may contribute to increased risk of cardiac dysfunction.
- Alecensa (alectinib) / Roche
Risk factors and clinical characteristics of pneumonitis among patients with ALK-rearranged non-small cell lung cancer who received alectinib and thoracic radiotherapy. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_5742;
The combined use of alectinib and TRT significantly increased the risk of pneumonitis. Clinicians should consider the elevated risks and related dosimetric factors when deciding on combination treatment for ALK-rearranged NSCLC patients.
- Next-generation sequencing (NGS) for identifying actionable molecular alterations in patients with newly diagnosed and recurrent IDHwt-glioblastoma (GBM): A large mono-institutional experience. (Available On Demand; 131) - Apr 28, 2022 - Abstract #ASCO2022ASCO_5176;
Potentially, a high rate of patients could receive a personalized treatment. The activity analysis is ongoing.
- Xalkori (crizotinib) / Pfizer
Efficacy and prognosis of sequential 2G ALK-TKI in ALK-positive advanced NSCLC after crizotinib resistance: A real-world single-center research. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_2990;
There was no significant difference in mPFS and mOS among patients treated with different 2G ALK-TKI. For patients with CNS metastases, treatment with Alectinib and Brigatinib results in higher ORR and PFS.
- Safety monitoring practice during the initiation of tyrosine kinase inhibitors (TKIs) for NSCLC treatment. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_2940;
Deviation from the manufacturer recommendation was most pronounced for CPK monitoring in alectinib. Future study is needed to define the clinical significance of deviation and to identify barriers to safety monitoring.
- Treatment patterns and outcomes in ALK or ROS1 altered NSCLC: An ATOMIC Registry Study. (Available On Demand; 64) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2842;
CNS metastases are common and subset analyses by agent and by year of diagnosis will be presented. Median time to CNS metastasis of > 2 years supports revision of the NCCN guidelines to include regular surveillance brain MRIs in this population.
- Alunbrig (brigatinib) / Takeda
Brigatinib in Japanese patients (pts) with ALK+ NSCLC: Final results from the phase 2 J-ALTA trial. (Available On Demand; 62) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2840;
P2
No new safety signals were observed in either cohort. Brigatinib demonstrated a favorable benefit-risk profile and is an important option for Japanese pts with ALK+ NSCLC regardless of TKI treatment history.
- Avastin (bevacizumab) / Roche, Alecensa (alectinib) / Roche
A phase II study of alectinib in combination with bevacizumab as first-line treatment in advanced NSCLC with confirmed ALK fusion: ALEK-B trial. (Available On Demand; 61) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2839;
P2
Moreover, it seems promising for patients with brain metastases. These results warrant the design of larger confirmatory trials, ideally a randomized phase III study.
- APG-2449 / Ascentage Pharma
First-in-human phase I results of APG-2449, a novel FAK and third-generation ALK/ ROS1 tyrosine kinase inhibitor (TKI), in patients (pts) with second-generation TKI-resistant ALK/ROS1+ non–small cell lung cancer (NSCLC) or mesothelioma. (Available On Demand; 58) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2836;
P1
Preliminary efficacy was observed in pts whose disease was resistant to second-generation TKIs, especially among those with brain metastases, and in TKI-naïve pts. Biomarker data indicated potential target engagement on FAK and immunomodulatory effects of APG-2449.
- || Alunbrig (brigatinib) / Takeda
Clinical, Journal, HEOR: Brigatinib is a cost-effective treatment in first-line anaplastic lymphoma kinase mutation-positive (ALK + ) advanced non-small cell lung cancer (NSCLC) with brain metastases. (Pubmed Central) - Apr 27, 2022
In conclusion, combining pharmacological costs of drugs with the measure of efficacy represented by PFS, both alectinib and brigatinib are cost-effective treatments in first-line for ALK+ NSCLC. In the BBM population brigatinib seems to be the most cost-effectiveness.
- || 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.
- || Alecensa (alectinib) / Roche
Clinical, Journal, HEOR: Alectinib in first-line treatment for advanced anaplastic lymphoma kinase mutation-positive (alk+) non-small cell lung cancer (NSCLC): a cost-effective change. (Pubmed Central) - Apr 20, 2022
This review will summarize the current situation of targeting the ALK signaling pathway. No abstract available
- ||||| Alecensa (alectinib) / Roche
Pan tumor: ALK as another tumor agnostic marker? MyPath pilot for alectinib. Disease control rate = 60% in ALK rearranged including PRs in colon and pancreatic and uterine leiomyosarcoma. No responses in ALK mutated or amplified (Twitter) - Apr 20, 2022
- | Alecensa (alectinib) / Roche
Journal: Acanthocytosis in an alectinib-treated patient. (Pubmed Central) - Apr 19, 2022
No abstract available No abstract available
- |||| Lorbrena (lorlatinib) / Pfizer, Alecensa (alectinib) / Roche
Clinical: Would say that w/toxicity favoring alectinib by many/most measures & w/efficacy of lorlatinib (& subsequent chemo) after alectinib, I think OS is a critical measure in ALK+. We know PFS diff would be far less impressive for lorlat vs. alectinib, perhaps w/no OS benefit. #LCSM (Twitter) - Apr 15, 2022
- | Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
Preclinical, Journal: Influence of alectinib and crizotinib on ionizing radiation - in vitro analysis of ALK/ROS1-wildtype lung tissue cells. (Pubmed Central) - Apr 15, 2022
Both KIs seems to be well tolerated in combination with thoracic radiotherapy and lacked synergistic reinforcement in cellular toxicity. This supports the feasibility of ALK/ROS1 inhibition in combination with thoracic irradiation in future clinical trials.
- | Alecensa (alectinib) / Roche
Journal: Target therapies in translocated ALK lung cancer: treatment management in oncology center of Lazio. (Pubmed Central) - Apr 14, 2022
In 2018, alectinib was approved in Italy for the first-line treatment of patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), becoming a new therapeutic option for this patient group which constitutes approximately 3-7% of patients with NSCLC...Maria Rita Migliorino. The aim of the meeting was to share their clinical experience and to provide a series of practical that can help clinicians during treatment with target therapies in ALK-positive NSCLC.
- || Alecensa (alectinib) / Roche
Clinical, Journal: ALK determination: liquid and tissue biopsy. Comparing techniques and effectiveness of alectinib in a controversial clinical case. (Pubmed Central) - Apr 13, 2022
ALK ve+ lung cancer today presents a large number of therapeutic opportunities leading to a long/term survival. Correct evaluation of ALK translocation is a paramount in order to guide the correct therapeutic strategy as illustrated in the present clinical case.
- || Alecensa (alectinib) / Roche
Clinical, Journal: Identification of anaplastic lymphoma kinase fusion in clear cell renal carcinoma (ALK-tRCC): a precision oncology medicine case report. (Pubmed Central) - Apr 13, 2022
Its diagnosis is very difficult because the genomic alteration spectrum is very wide. We suggested that metastatic RCCs should be screened for uncommon genomic alterations expecially in good performance status pretreated resistant/refractory patients.
- ||| Retrospective data, Journal, Adverse events: Psychiatric Adverse Reactions to Anaplastic Lymphoma Kinase Inhibitors in Non-Small-Cell Lung Cancer: Analysis of Spontaneous Reports Submitted to the FDA Adverse Event Reporting System. (Pubmed Central) - Apr 13, 2022
We suggested that metastatic RCCs should be screened for uncommon genomic alterations expecially in good performance status pretreated resistant/refractory patients. Notwithstanding limitations, our study found a higher proportion of psychiatric AEs with lorlatinib, but also raised the hypothesis of psychiatric reactions as a class effect of ALK TKIs.
- | Tepmetko (tepotinib) / EMD Serono
Journal: Tepotinib Improves Prognosis in an Elderly Patient with Poor Performance Status and MET Exon 14 Skipping Mutation-positive Non-small Cell Lung Cancer. (Pubmed Central) - Apr 13, 2022
Gefitinib and alectinib have been reported as being effective and safe even in those with poor performance status (PS), but little is known about efficacy and tolerability of other TKIs...During the initial treatment with carboplatin and nab-paclitaxel, his Eastern Cooperative Oncology Group PS increased to 3...His PS improved to 0-1 and partial response was maintained for 12 months or more. The MET exon 14 skipping mutation is common in the elderly, and TKI treatment may improve prognosis, even in patients with reduced PS.
- || Alecensa (alectinib) / Roche
Alectinib is better tolerated (Twitter) - Apr 13, 2022
- | Alecensa (alectinib) / Roche
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 13, 2022
P=N/A, N=1, Active, not recruiting, Sponsor: Pfizer
The MET exon 14 skipping mutation is common in the elderly, and TKI treatment may improve prognosis, even in patients with reduced PS. Trial completion date: Dec 2021 --> Jul 2023 | Trial primary completion date: Dec 2021 --> Jul 2023
- | 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.
- || Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
Retrospective data, Review, Journal: Chemotherapy versus alectinib for the treatment of crizotinib-pretreated ALK-positive patients with non small cell lung cancer: A protocol for systematic review and meta-analysis. (Pubmed Central) - Apr 7, 2022
Regarding developing agents, lorlatinib and ensartinib appear to be the most promising ones, even though the data from their trials are still immature. The review will add to the existing literature by showing compelling evidence and improved guidance in clinic settings.
- | Alunbrig (brigatinib) / Takeda, Alecensa (alectinib) / Roche
Journal: ALK-rearranged lung adenocarcinoma resistant to alectinib with cauliflower gingival metastasis responds to brigatinib. (Pubmed Central) - Apr 6, 2022
The review will add to the existing literature by showing compelling evidence and improved guidance in clinic settings. No abstract available
- | Alecensa (alectinib) / Roche
Trial primary completion date, Metastases: A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors (clinicaltrials.gov) - Apr 6, 2022
P2, N=50, Recruiting, Sponsor: Hoffmann-La Roche
No abstract available Trial primary completion date: Dec 2025 --> Aug 2025
- | Alecensa (alectinib) / Roche
Trial completion date, Trial primary completion date: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors (clinicaltrials.gov) - Apr 6, 2022
P1/2, N=42, Recruiting, Sponsor: Hoffmann-La Roche
Trial primary completion date: Dec 2025 --> Aug 2025 Trial completion date: Dec 2031 --> Jul 2030 | Trial primary completion date: Jun 2027 --> Jun 2026
- || Alecensa (alectinib) / Roche
Clinical, Journal: Pharmacometric analyses of alectinib to facilitate approval of the optimal dose for the first-line treatment of anaplastic lymphoma kinase-positive non-small cell lung cancer. (Pubmed Central) - Apr 5, 2022
These pharmacometric results were used to expedite and facilitate regulatory approvals of 600 mg b.i.d. for first-line ALK-positive NSCLC in the United States and European Union in 2017 and in China in 2018.
- | Alecensa (alectinib) / Roche
Journal: Successful salvage surgery followed by second ALK-TKI after alectinib failure in a patient with ALK-positive NSCLC. (Pubmed Central) - Apr 3, 2022
for first-line ALK-positive NSCLC in the United States and European Union in 2017 and in China in 2018. Our experience with this case suggests that salvage surgery after alectinib treatment followed by lorlatinib therapy may be effective for initially unresectable ALK-positive NSCLC.
- | Symproic (naldemedine) / Shionogi, Collegium Pharma, Alecensa (alectinib) / Roche
Journal: Identification and characterization of novel RdRp and Nsp15 inhibitors for SARS-COV2 using computational approach. (Pubmed Central) - Mar 31, 2022
Finally, we propose that the identified inhibitors represent a novel lead molecule to design a more effective inhibitor to stop the progress of pathogen. Communicated by Ramaswamy H. Sarma.
- |||| Alunbrig (brigatinib) / Takeda
Trial primary completion date, Metastases: ALTA-3: A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer (clinicaltrials.gov) - Mar 28, 2022
P3, N=246, Recruiting, Sponsor: Takeda
Communicated by Ramaswamy H. Sarma. Trial primary completion date: Jan 2022 --> Apr 2023
- || Lorbrena (lorlatinib) / Pfizer, Alecensa (alectinib) / Roche
Alectinib ➡️ Lorlatinib! #ALK 3rd gen https://t.co/errJDOLONu (Twitter) - Mar 27, 2022
- |||| Zykadia (ceritinib) / Novartis, Alecensa (alectinib) / Roche
Clinical, Real-world evidence: Assessment of Alectinib vs Ceritinib in ALK-Positive NSCLC in Phase 2 Trials and Real-world Data https://t.co/EKyc2TF5ql via @JAMANetworkOpen part of @JAMANetwork (Twitter) - Mar 26, 2022
- |||| Zykadia (ceritinib) / Novartis, Alecensa (alectinib) / Roche
Clinical, Real-world evidence: Assessment of Alectinib vs Ceritinib in ALK-Positive NSCLC in Phase 2 Trials and Real-world Data https://t.co/EKyc2TF5ql via @JAMANetworkOpen part of @JAMANetwork (Twitter) - Mar 26, 2022
- || Lorbrena (lorlatinib) / Pfizer, Alunbrig (brigatinib) / Takeda, Alecensa (alectinib) / Roche
Retrospective data, Review, Journal: Comparison of lorlatinib, alectinib and brigatinib in ALK inhibitor-naive/untreated ALK-positive advanced non-small-cell lung cancer: a systematic review and network meta-analysis. (Pubmed Central) - Mar 25, 2022
In terms of progression free survival, our results indicated that lorlatinib was the best treatment choice for patients with ALK inhibitor-naive or untreated (ALK inhibitor-naive and chemotherapy-naive) ALK-positive advanced NSCLC. The future head-to-head trials assessing the relative efficacy of lorlatinib, alectinib and brigatinib were warranted.
- ||| Clinical, P4 data, Journal, Adverse events: Postmarketing safety of anaplastic lymphoma kinase (ALK) inhibitors: an analysis of the FDA Adverse Event Reporting System (FAERS). (Pubmed Central) - Mar 25, 2022
We found several significant safety signals that matched previously published case reports, including pulmonary arterial hypertension, rectal perforation, myasthenia gravis, and photosensitivity. These signals require further regulatory investigation to determine their significance and potentially update the product labels to inform patients and clinicians.
- || Avastin (bevacizumab) / Roche, Alecensa (alectinib) / Roche
Clinical, P1/2 data, Journal: Safety and activity of alectinib plus bevacizumab in patients with advanced ALK-rearranged non-small-cell lung cancer: a phase I/II study. (Pubmed Central) - Mar 25, 2022
These signals require further regulatory investigation to determine their significance and potentially update the product labels to inform patients and clinicians. Alectinib plus bevacizumab was well tolerated without unanticipated toxicities or dose-limiting toxicities.