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13 Diseases |  |
52 Trials |
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52 Trials |  |
3235 News |  |
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- | Alecensa (alectinib) / Roche
Journal: Central nervous system relapse of systemic ALK-rearranged anaplastic large cell lymphoma treated with alectinib. (Pubmed Central) - May 23, 2020
No abstract available
- ||| Alecensa (alectinib) / Roche
Clinical, Adverse events: I doubt it will cause competition and a price drop. It’s nice to have an option though if there are drug shortages, or if a patient is having an intolerable side effect of alectinib that didn’t show up in clinical trials. One or two ‘me too’ drugs are ok in back pocket (Twitter) - May 23, 2020
- ||| Alecensa (alectinib) / Roche
Clinical: Enough to compete with alectinib in first line? (Twitter) - May 22, 2020
- ||| Alecensa (alectinib) / Roche
But here’s what’s not featured: OS falls below that of alectinib in 1L ALEX trial. Yes, it’s cross-trial comparison, but unfortunately this is another approval that is a lateral move on its best day compared to current standard of care in same indication, if not inferior. #LCSM (Twitter) - May 22, 2020
- || Alecensa (alectinib) / Roche
Alectinib is associated with a relatively high incidence of hepatotoxicity, and I have had to dose reduce quite a few times. Dose reduction is easy, but the overall pill burden with alectinib is substantial due to 150 mg caps and 600 mg BID dosing (Twitter) - May 22, 2020
- TPX-0131 / Turning Point Therapeutics
TPX-0131: A next generation macrocyclic ALK inhibitor that overcomes ALK resistant mutations refractory to current approved ALK inhibitors (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_3327;
Second generation ALK inhibitors alectinib, ceritinib, and brigatinib were able to overcome the majority of ALK resistant mutations (L1196M, G1269A and F1174L) acquired with crizotinib...Lorlatinib, a third generation ALK inhibitor, can overcome G1202R resistance with moderate IC50 values of 40 - 60 nM in cell-based assays...Taken together, TPX-0131 is a next generation ALK inhibitor that can overcome a broad spectrum of acquired resistance mutations, especially the G1202R solvent front mutation and compound mutations (e.g. L1196M/G1202R). The nonclinical pharmacology profile of TPX-0131 warrants further preclinical investigation.
- ensartinib (X-396) / Xcovery
Ensartinib (X-396), a novel ALK TKI, in Chinese ALK-positive non-small cell lung cancer: A phase I, dose-escalation and expansion study (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_3184;
P1, P3
RP2D was established at 225 mg QD. Ensartinib could penetrate the blood-brain barrier with a CSF/plasma concentration ratio of 1.65%, supporting its remarkable intracranial efficacy.
- Alecensa (alectinib) / Roche
nCounter for detection of clinically relevant alterations in exosomes of non-small cell lung cancer cells and patients (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_2187;
Exosomes from a cell line established from a patient progressing to alectinib were also positive for EML4-ALKv1and showed high MET expression levels, while exosomes from the fusion-negative cell lines A549 and H23 tested negative. nCounter can detect ALK, RET and ROS1 fusion transcripts in exosomes purified from the blood of advanced NSCLC patients
- vinblastine / Generic mfg.
[VIRTUAL] EARLY RESPONSE OBSERVATION IN ALK KINASE INHIBITORS COMBINED WITH/WITHOUT VINBLASTINE IN PEDIATRIC REFRACTORY/RELAPSED ALK+ ANAPLASTIC LARGE CELL LYMPHOMA () - May 16, 2020 - Abstract #EHA2020EHA_897;
Most treatment-related adverse events are mild and manageable. Sequential use of ALK kinase inhibitors can be an efficient strategy to counter drug resistance.
- | Alecensa (alectinib) / Roche
Journal: Anaplastic lymphoma kinase regulates internalization of the dopamine D2 receptor. (Pubmed Central) - May 15, 2020
The ALK inhibitor alectinib completely inhibited dopamine-induced D2R internalization...Dopamine activated protein kinase C in an ALK-dependent manner and a PKC inhibitor blocked dopamine D2 receptor internalization. These results indicate that ALK regulates dopamine D2 receptor trafficking, which has implications for psychiatric disorders involving dysregulated dopamine signaling.
- || Tagrisso (osimertinib) / AstraZeneca, Alecensa (alectinib) / Roche
Review, Journal: Oncogene-Addicted Non-Small-Cell Lung Cancer: Treatment Opportunities and Future Perspectives. (Pubmed Central) - May 14, 2020
Currently, osimertinib (which demonstrated to improve efficacy with a better tolerability in comparison with first-generation TKIs) is considered the best treatment option for patients affected by NSCLC harboring a common EGFR mutation...To date, alectinib is considered the best treatment option for these patients, with other newer agents upcoming...In this narrative review, the state of art of scientific literature about targeted therapy options in oncogene-addicted disease is summarized and critically discussed. We also aim to analyze future perspectives to maximize benefits for this subgroup of patients.
- || Retrospective data, Review, Journal: ALK inhibitors for non-small cell lung cancer: A systematic review and network meta-analysis. (Pubmed Central) - May 11, 2020
Treatment-related deaths were infrequent among ALK-positive NSCLC. PFS may be improved by alectinib and brigatinib relative to other ALK inhibitors; however, the assessment of OS is likely confounded by treatment crossover and should be interpreted with caution.
- Mekinist (trametinib) / Novartis, trametinib, Alecensa (alectinib) / Roche
Combination Therapy of GD2-Specific CAR-T Cells with Tyrosine Kinase Inhibitors for Neuroblastoma () - May 9, 2020 - Abstract #ASGCT2020ASGCT_25;
Alectinib synergistically enhances the cytotoxic activity of GD2-CAR-T cells by reducing the expression of PD-L1 in tumor cells, and may therefore be a promising therapeutic option for neuroblastoma when used in combination with GD2-CAR-T cells. Trametinib, on the other hand, completely inhibits the activity of GD2-CAR-T cells, which may make it useful as a safeguard for when serious adverse events such as off-target effects occur during CAR-T cell therapy.
- || Trial completion date, Trial primary completion date: CUPISCO: A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site (clinicaltrials.gov) - May 7, 2020
P2, N=790, Recruiting, Sponsor: Hoffmann-La Roche
Trametinib, on the other hand, completely inhibits the activity of GD2-CAR-T cells, which may make it useful as a safeguard for when serious adverse events such as off-target effects occur during CAR-T cell therapy. Trial completion date: Jun 2022 --> Jun 2023 | Trial primary completion date: Jun 2021 --> Jun 2022
- || Biomarker, Clinical, P1/2 data, Journal, PD(L)-1 Biomarker: N2M2 (NOA20) phase I/II trial of molecularly matched targeted therapies plus radiotherapy in patients with newly diagnosed non-MGMT hypermethylated glioblastoma. (Pubmed Central) - May 2, 2020
Patients without matching alterations are randomized between subtrials without strong biomarkers using atezolizumab and asinercept (APG101) and the standard of care, TMZ...For the phase I parts, a Bayesian criterion is used for continuous monitoring of toxicity. In the phase II trials, progression-free survival at six months is used as endpoint for efficacy.
- || Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date: IMbrella B: A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (clinicaltrials.gov) - May 1, 2020
P4, N=1000, Recruiting, Sponsor: Hoffmann-La Roche
In the phase II trials, progression-free survival at six months is used as endpoint for efficacy. Trial completion date: Dec 2028 --> Jul 2028 | Trial primary completion date: Dec 2028 --> Jul 2028
- Avastin (bevacizumab) / Roche, Alecensa (alectinib) / Roche
[VIRTUAL] A phase II and biomarker study of alectinib combined with bevacizumab in ALK-positive nonsquamous non-small cell lung cancer. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_5665;
- Alecensa (alectinib) / Roche
[VIRTUAL] A phase II trial of alectinib-refractory non-small cell lung cancer with EML4- ALK fusion genes: Okayama lung cancer study group 1405. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_5629;
- Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
[VIRTUAL] Preliminary analyses of ALK-positive non-small-cell lung cancer (NSCLC) patients with first-used alectinib or crizotinib followed by alectinib: A multicenter cohort realworld study in China. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_5575;
- repotrectinib (TPX-0005) / Turning Point Therapeutics, dasatinib / Generic mfg., Alecensa (alectinib) / Roche
[VIRTUAL] YES1 amplification as a primary driver of lung tumorigenesis and YES1/YAP1 amplifications as mediators of acquired resistance (AR) to ALK and EGFR tyrosine kinase inhibitors (TKIs). () - Apr 29, 2020 - Abstract #ASCO2020ASCO_5534;
SFK inhibition can potentially be exploited to therapeutically target YES1 amplification as a primary driver in tumorigenesis and YES1/YAP1 amplifications as mediators of AR to ALK and EGFR TKIs. Research Funding: Memorial Sloan Kettering Functional Genomics Initiative
- Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Evaluation of immune-related adverse events in patients treated with sequential immunotherapy and tyrosine kinase inhibitor treatment in non-small cell lung cancer. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_5505;
Overall and progression-free survival were considered in this cohort. Preliminary data suggested that EGFR-TKI treated patients have low response to immune checkpoint inhibitors, but outcomes vary by allele variation.
- Avastin (bevacizumab) / Roche, Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Venous thromboembolism (VTE) incidence and risk factors in patients (pts) with non-small cell lung cancer (NSCLC) receiving front-line therapy. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_5002;
Khorana risk score was significantly associated with VTE risk and may identify those likely to benefit from thromboprophylaxis. *HR: hazard ratio †Comorbidities included diabetes, central venous catheter, pacemaker, heart failure, atrial fibrillation, liver disease, kidney disease, nicotine dependence, prior VTE.
- [VIRTUAL] Trends in ALK inhibitors for non-small cell lung cancer. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_3210;
Furthermore, the increased ER and in-patient costs may substantiate the findings of the ALEX trial, notably higher liver toxicity and more nausea, vomiting, and diarrhea for crizotinib. There is not yet sufficient data on the newer ALK inhibitors, brigatinib and lorlatinib in the real-world.
- [VIRTUAL] Longitudinal monitoring by next generation sequencing of plasma cell-free DNA in ALK-rearranged non-small cell lung cancer (NSCLC) patients treated with ALK tyrosine kinase inhibitors. (Poster Board 369) - Apr 29, 2020 - Abstract #ASCO2020ASCO_2456;
NGS of cell-free plasma DNA is useful not only for the detection of ALK fusions and resistance mutations but also for assessing prognosis and monitoring the dynamic changes of genomic alterations in ALK+ NSCLC treated with ALK TKI. Research Funding: Bio & Medical Technology Development Program of the National Research Foundation (NRF) funded by the Korean government (MSIT) (No.NRF-2017M3A9G5060259)Bio & Medical Technology Development Program of the National Research Foundation (NRF) funded by the Kor
- Alunbrig (brigatinib) / Takeda
[VIRTUAL] Brigatinib in Japanese ALK positive NSCLC patients previously treated with ALK tyrosine kinase inhibitors: J-ALTA. (Poster Board 303) - Apr 29, 2020 - Abstract #ASCO2020ASCO_2395;
P2
The safety profile of brigatinib was consistent with prior studies and no new safety findings were identified. Research Funding: Takeda Pharmaceutical Company Ltd
- Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
[VIRTUAL] Updated overall survival (OS) and safety data from the randomized, phase III ALEX study of alectinib (ALC) versus crizotinib (CRZ) in untreated advanced ALK+ NSCLC. (Poster Board 284) - Apr 29, 2020 - Abstract #ASCO2020ASCO_2374;
P3
This is the first global randomized study of a 2nd generation ALK TKI to demonstrate a clinically meaningful improvement in OS vs CRZ in ALK+ NSCLC (5-year survival rate: 62.5%, ALC vs 45.5%, CRZ); longer FU is required as OS data remain immature. Research Funding: F. Hoffman-La Roche Ltd
- Alecensa (alectinib) / Roche
[VIRTUAL] Cost-effectiveness of genomic profiling in veterans with metastatic lung adenocarcinoma. (Poster Board 347) - Apr 29, 2020 - Abstract #ASCO2020ASCO_2019;
Tumor profiling (TGPT or MGPS) can optimize anticancer therapy selection in patients with metastatic lung adenocarcinoma and improve quality-adjusted survival, but compared to no tumor profiling, is not cost-effective. Research Funding: None
- [VIRTUAL] Correlation between overall response rate and progression-free survival/overall survival in comparative trials involving targeted therapies in molecularly enriched populations. (Poster Board 318) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1538;
Establishing a correlation between ORR and OS was limited, most probably due to confounding factors such as treatment cross-over following progression, number of subsequent therapies and long post-progression survival in this setting. These findings further warrant the use of ORR as a surrogate for PFS in biomarker-driven studies.
- || Alecensa (alectinib) / Roche
Clinical, Retrospective data, Journal: Efficacy of Alectinib in Patients with ALK-Positive NSCLC and Symptomatic or Large CNS Metastases. (Pubmed Central) - Apr 29, 2020
These findings further warrant the use of ORR as a surrogate for PFS in biomarker-driven studies. Alectinib demonstrated meaningful CNS efficacy in ALK-positive NSCLC patients with untreated, symptomatic or large brain metastases.
- ||| Alecensa (alectinib) / Roche
I agree. Also might explain why some recent ctDNA-based trials observed higher than expected response rates (e.g. BFAST-Alectinib in NSCLC compared to ALEX trial) (Twitter) - Apr 28, 2020
- ||| capmatinib (INC280) / Incyte, Novartis, Alecensa (alectinib) / Roche
Yes, I've been taking capmatinib and alectinib together since December with good results. #lcsm (Twitter) - Apr 27, 2020
- | Alunbrig (brigatinib) / Takeda, Alecensa (alectinib) / Roche
Journal: Activity of brigatinib in the setting of alectinib resistance mediated by ALK-I1171S in ALK rearranged lung cancer. (Pubmed Central) - Apr 24, 2020
Alectinib demonstrated meaningful CNS efficacy in ALK-positive NSCLC patients with untreated, symptomatic or large brain metastases. No abstract available
- ||| Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
Clinical, P3 data, Journal: Alectinib versus crizotinib in untreated Asian patients with anaplastic lymphoma kinase-positive non-small-cell lung cancer (ALESIA): a randomised phase 3 study. (Pubmed Central) - Apr 22, 2020
P3
No abstract available Our results align with ALEX, confirming the clinical benefit of 600 mg of alectinib twice per day as a first-line treatment for ALK-positive non-small-cell lung cancer.
- | Alecensa (alectinib) / Roche
Journal: Exploring the optimal use of alectinib. (Pubmed Central) - Apr 22, 2020
Our results align with ALEX, confirming the clinical benefit of 600 mg of alectinib twice per day as a first-line treatment for ALK-positive non-small-cell lung cancer. No abstract available
- || Alecensa (alectinib) / Roche
Clinical, Journal, HEOR: Response Letter to "Letter: Cost-Effectiveness of Alectinib for Patients with Untreated ALK-Positive Non-Small Cell Lung Cancer in China". (Pubmed Central) - Apr 21, 2020
No abstract available No abstract available
- || Alecensa (alectinib) / Roche
Clinical, Journal, HEOR: Letter: Cost-Effectiveness of Alectinib for Patients with Untreated ALK-Positive Non-Small-Cell Lung Cancer in China. (Pubmed Central) - Apr 21, 2020
No abstract available No abstract available
- ||| Tecentriq (atezolizumab) / Roche, Alecensa (alectinib) / Roche
Trial completion, Combination therapy, PD(L)-1 Biomarker, Metastases: A Phase 1b Study of Atezolizumab in Combination With Erlotinib or Alectinib in Participants With Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - Apr 21, 2020
P1b, N=52, Completed, Sponsor: Hoffmann-La Roche
No abstract available Active, not recruiting --> Completed
- | Alecensa (alectinib) / Roche
Clinical, Journal: Safety and Efficacy of Alectinib in a Patient With Advanced NSCLC Undergoing Hemodialysis. (Pubmed Central) - Apr 17, 2020
Active, not recruiting --> Completed No abstract available
- |||||| Alecensa (alectinib) / Roche
New trial: Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns (clinicaltrials.gov) - Apr 16, 2020
P, N=1, Recruiting, Sponsor: Pfizer
- || Alunbrig (brigatinib) / Takeda, Alecensa (alectinib) / Roche
Retrospective data, Review, Journal: Brigatinib and Alectinib for ALK Rearrangement-Positive Advanced Non-Small Cell Lung Cancer With or Without Central Nervous System Metastasis: A Systematic Review and Network Meta-Analysis. (Pubmed Central) - Apr 16, 2020
This study provides critical information to clinicians regarding the efficacy of brigatinib for ALK-p, ALK-inhibitor-naïve, advanced NSCLC patients, with and without CNS metastasis. Larger randomized, controlled trials are warranted to confirm our results.
- |||||| Clinical: #MET amplification was seen in 12% of patients post 2nd-gen #ALK TKI and 22% of patients post-lorlatinib. With first line alectinib and brigatinib, MET amplification seems more likely (logical given activity of crizotinib at MET). MET rearrangements also identified! #LCSM (Twitter) - Apr 16, 2020
- | Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Retrospective data, Journal: Comparative Efficacy of Targeted Therapies in Patients with Non-Small Cell Lung Cancer: A Network Meta-Analysis of Clinical Trials. (Pubmed Central) - Apr 15, 2020
Compared with chemotherapy, both ORR and PFS were significantly improved for afatinib, alectinib, and crizotinib, while only PFS was significantly improved for cabozantinib, ceritinib, gefitinib, and osimertinib...Cabozantinib and alectinib showed the highest probability for the first-line treatment ranking in ORR (62.5%) and PFS (87.5%), respectively. The current network meta-analysis showed the comprehensive evidence-based comparative efficacy of different types of targeted therapies, which would help clinicians use targeted therapies in clinical practice.
- || Alecensa (alectinib) / Roche
Clinical, Journal, HEOR: Cost-Effectiveness of Alectinib for Patients with Untreated ALK-Positive Non-Small Cell Lung Cancer in China. (Pubmed Central) - Apr 12, 2020
Alectinib could prolong the mean time of PF and delay the time to CNS progression. However, because of its high drug cost, alectinib was unlikely to be cost-effective for untreated ALK-positive NSCLC patients in China.
- || Retrospective data, Review, Journal: The incidence of ALK inhibitor-related pneumonitis in advanced non-small-cell lung cancer patients: A systematic review and meta-analysis. (Pubmed Central) - Apr 10, 2020
The overall incidence of ALK inhibitor pneumonitis was 2.14% in patients with advanced NSCLS. The patients from Japanese cohorts had a higher incidence of ALK-inhibitor pneumonitis, which indicates the need for increased awareness and caution for pneumonitis in Japanese patients treated with ALK inhibitors.
- || Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
Clinical, Journal, HEOR: Cost-effectiveness of alectinib compared to crizotinib for the treatment of first-line ALK+ advanced non-small-cell lung cancer in France. (Pubmed Central) - Apr 10, 2020
The incremental cost per life year gained was 115,334 €/year and the incremental cost-effectiveness ratio was 90,232 €/QALY. First-line treatment of ALK+ NSCLC with alectinib provides superior clinical outcomes to crizotinib and is cost-effective in the French context.
- ||||| New P2 trial, PD(L)-1 Biomarker: ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling (clinicaltrials.gov) - Apr 9, 2020
P2, N=300, Not yet recruiting, Sponsor: Ulrik Lassen
- || Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
Clinical, Journal, HEOR: Cost analysis of the management of brain metastases in patients with advanced ALK+ NSCLC: alectinib versus crizotinib. (Pubmed Central) - Apr 9, 2020
With alectinib, average cost/patient was lower than crizotinib (€4948.51/patient-year). Prevention of BM with alectinib may result in reductions of cost/year in the management of advanced ALK+ NSCLC.
- || Biomarker, Trial initiation date: NAUTIKA1: A Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer (clinicaltrials.gov) - Apr 5, 2020
P2, N=60, Not yet recruiting, Sponsor: Genentech, Inc.
Prevention of BM with alectinib may result in reductions of cost/year in the management of advanced ALK+ NSCLC. Initiation date: Apr 2020 --> Jul 2020
- | Afinitor (everolimus) / Novartis, Alecensa (alectinib) / Roche
Journal: Synergistic Effect of Alectinib and Everolimus on ALK-positive Anaplastic Large Cell Lymphoma Growth Inhibition. (Pubmed Central) - Apr 1, 2020
Initiation date: Apr 2020 --> Jul 2020 The combination of both inhibitors synergistically inhibits ALK-positive ALCL cell growth via the ALK/mTOR pathway.
- | Alecensa (alectinib) / Roche
Journal: YAP1 mediates survival of ALK-rearranged lung cancer cells treated with alectinib via pro-apoptotic protein regulation. (Pubmed Central) - Mar 25, 2020
Using patient-derived cell line models, we herein demonstrate that cancer cells survive a treatment with alectinib by activating Yes-associated protein 1 (YAP1), which mediates the expression of the anti-apoptosis factors Mcl-1 and Bcl-xL, and combinatorial inhibition against both YAP1 and ALK provides a longer tumor remission in ALK-rearranged xenografts when compared with alectinib monotherapy. These results suggest that the inhibition of YAP1 is a candidate for combinatorial therapy with ALK inhibitors to achieve complete remission in patients with ALK-rearranged lung cancer.