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13 Diseases |  |
52 Trials |
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52 Trials |  |
3235 News |  |
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- || Lorbrena (lorlatinib) / Pfizer, Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
Yes, and alectinib, crizotinib, lorlatinib etc, too @UKALK1 (Twitter) - Mar 23, 2020
- | Trial initiation date, Adverse events, Checkpoint inhibition: PD-1 Immune Checkpoint Inhibitors and Immune-Related Adverse Events: a Cohort Study (clinicaltrials.gov) - Mar 23, 2020
P=N/A, N=4724, Not yet recruiting, Sponsor: Sungkyunkwan University
Initiation date: Jan 2020 --> Apr 2020
- | Alecensa (alectinib) / Roche
Journal: ALK testing methods: Is there a winner or loser? (Pubmed Central) - Mar 20, 2020
However, it was revealed that patients with IHC-positivity and FISH-negativity may respond to alectinib, indicating that IHC can be used as a stand-alone method from a clinical standpoint for the identification of patients eligible for treatment with ALK inhibitors. In addition, differences between ALK variants have been reported to affect the prognosis and efficacy of ALK inhibitor-based treatments, and RT-PCR will likely increase in importance as a complementary tool.
- |||| Trial completion date, Trial primary completion date, Tumor mutational burden, IO Companion diagnostic, PD(L)-1 Biomarker, PD(L)-1 companion diagnostic, Metastases: BFAST: A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - Mar 18, 2020
P2/3, N=660, Recruiting, Sponsor: Hoffmann-La Roche
In addition, differences between ALK variants have been reported to affect the prognosis and efficacy of ALK inhibitor-based treatments, and RT-PCR will likely increase in importance as a complementary tool. Trial completion date: Sep 2020 --> Sep 2021 | Trial primary completion date: Sep 2020 --> Sep 2021
- || Clinical, Journal: Drug resistance mechanisms in Japanese ALK positive NSCLC and the clinical responses based on the resistant mechanisms. (Pubmed Central) - Mar 17, 2020
L1196M + G1202R, a compound mutation, was detected in 1 specimen after lorlatinib treatment...In conclusion, resistance to ALK-TKIs based on secondary mutation in this study was similar to that in previous reports, except for crizotinib resistance. The appropriate treatment matching resistance mechanisms contributes to the efficacy of multiple ALK-TKI treatment strategies.
- ||||| Alecensa (alectinib) / Roche
Clinical: Phone call: Me: How r u doing? Pt: I was worried about you! Did you check your temp today? Any symptoms? (6+ Qs) Me: Lets talk about u Pt: Recites lab work, AEs of Alectinib and goes over ROS... I'm OK Pt: Call me if you have any symptoms! Our pts are the best! #COVID19 (Twitter) - Mar 17, 2020
- vinorelbine tartrate / Generic mfg., Opdivo (nivolumab) / Ono Pharma, BMS
Granulocyte Colony-Stimulating Factor-Producing Anaplastic Lymphoma Kinase-Positive Lung Cancer (PENNSYLVANIA CONVENTION CENTER, Hall D-E (200 Level), Area A) - Mar 15, 2020 - Abstract #ATS2020ATS_8775;
Gemcitabine/vinorelbine chemotherapy was administered but the lung cancer eventually exacerbated and the patient died 5 months after the first visit...Therefore, a marked increase in the WBC count at initial diagnosis can be indicative of G-CSF-producing lung cancer. Surgical resection should be considered as a first option in case of diagnosed G-CSF-producing lung cancer, because although ALK is positive, the response to medical treatment is expected to be poor.
- Alecensa (alectinib) / Roche
Alectinib Induced Interstitial Pneumonitis / ILD (PENNSYLVANIA CONVENTION CENTER, Hall D-E (200 Level), Area A) - Mar 15, 2020 - Abstract #ATS2020ATS_6413;
This case highlights the importance of looking for drug-induced lung injury, detecting them early and intervening appropriately to prevent significant lung injury. Although, there have been reports of ILD associated with ALK inhibitors, alectinib induced interstitial pneumonitis/ILD is not very common.
- | Alecensa (alectinib) / Roche
Journal: Tree-in-bud Pattern in ALK-positive Lung Adenocarcinoma. (Pubmed Central) - Mar 13, 2020
Although, there have been reports of ILD associated with ALK inhibitors, alectinib induced interstitial pneumonitis/ILD is not very common. No abstract available
- ||| Alecensa (alectinib) / Roche
Clinical: Would be interesting to see early évidences of external control arms ? @rochegroup and @flatironhealth alectinib HTA case study remains anecdotal. (Twitter) - Mar 11, 2020
- |||| Biomarker, New P2 trial: NAUTIKA1: A Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer (clinicaltrials.gov) - Mar 10, 2020
P2, N=60, Not yet recruiting, Sponsor: Genentech, Inc.
- [VIRTUAL] A PAN-EUROPEAN HTA, A SINGLE US PAYER? () - Mar 8, 2020 - Abstract #ISPOR2020ISPOR_1468;
Despite political pressure at the European level there seems little appetite to harmonize HTA nationally. The lack of historical HTA across the US payer landscape is one less hurdle for proponents of a single payer system in the US.
- ||| Alecensa (alectinib) / Roche
VOLUME 11 ● NÚMERO 02 Eficácia do alectinibe no câncer de pulmão de células não pequenas ALK+ @CarolinaKHaddad @RoselyYamamura @camillayamada @FabioSchutz78 @thiagoonco https://t.co/t45rtsKADo (Twitter) - Mar 7, 2020
- ||| Alunbrig (brigatinib) / Takeda, Alecensa (alectinib) / Roche
What's the difference between Alectinib and brigatinib about ALK+ treat (Twitter) - Mar 4, 2020
- | Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis, Alecensa (alectinib) / Roche
Retrospective data, Journal: Efficacy of Crizotinib, Ceritinib, and Alectinib in ALK-Positive Non-Small Cell Lung Cancer Treatment: A Meta-Analysis of Clinical Trials. (Pubmed Central) - Mar 1, 2020
Further head-to-head trials are needed to compare their efficacy with other types of NSCLC treatment regimens. PROSPERO registration: CRD42018085987.
- |||| Zykadia (ceritinib) / Novartis, Alunbrig (brigatinib) / Takeda, Alecensa (alectinib) / Roche
Clinical: There was no FLAURA already existing in the ALK space when alectinib came out, only ceritinib. I would more compare this to the brigatinib data NOW, no clinical need for it and now imagine if it was IV too. (Twitter) - Feb 29, 2020
- |||| Alecensa (alectinib) / Roche
But how much did we pause before declaring alectinib 1L SOC for ALK+ NSCLC despite no demonstrated OS benefit? We were thrilled w/PFS 18.9 mo w/osi & made it 1L SOC w/o OS benefit. Not saying I prefer it to osi, but crushing PFS benefit has always been enough for approval. (Twitter) - Feb 28, 2020
- ||||| Alecensa (alectinib) / Roche
Clinical: No, I don't think that we will all want to individualize, but rather that I think it's appropriate to have the option available to people who want it. Alectinib gives huge PFS benefit w/no proven OS benefit. What is difference between RELAY regimen & alectinib for ALK+ NSCLC? (Twitter) - Feb 27, 2020
- || Alecensa (alectinib) / Roche
I think I wouldn't recommend it, but my view is really that I think having more options is beneficial, & I do think we need to use same metrics to judge our treatments. As I said in another tweet, RELAY data are vy similar to alectinib in ALEX. Do we require OS or don't we? (Twitter) - Feb 27, 2020
- Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
[VIRTUAL] Different response to ALK inhibitors in EML4-ALK positive mediastinal cancer of unknown primary. () - Feb 27, 2020 - Abstract #ASCO2020ASCO_39;
ALK inhibitor alectinib is expected to improve outcomes of patients with ALK-positive MCUP. NGS and PD-L1 testing should be recommended for MCUP to get more information about therapy and efficacy.
- || Clinical, Journal: Comparative efficacy of brigatinib versus ceritinib and alectinib in patients with crizotinib-refractory anaplastic lymphoma kinase-positive non-small cell lung cancer. (Pubmed Central) - Feb 25, 2020
NGS and PD-L1 testing should be recommended for MCUP to get more information about therapy and efficacy. In crizotinib-refractory ALK + NSCLC patients, relative efficacy estimates suggest brigatinib may have prolonged PFS and OS vs ceritinib and prolonged PFS vs alectinib.
- | pemetrexed / Generic mfg., Alecensa (alectinib) / Roche
Observational data, Retrospective data, Journal: Real Clinical Practice in ALK-rearranged NSCLC Patients: A Retrospective Observational Study. (Pubmed Central) - Feb 21, 2020
In crizotinib-refractory ALK + NSCLC patients, relative efficacy estimates suggest brigatinib may have prolonged PFS and OS vs ceritinib and prolonged PFS vs alectinib. By arrangement of treatment such as treatment sequence of ALK-TKI and chemotherapy regimen, it might be possible to obtain a treatment outcome almost equivalent to those of clinical trials even in real clinical practice.
- Alecensa (alectinib) / Roche
Alectinib + bev or other (STARLIGHT BALLROOM) - Feb 21, 2020 - Abstract #IASLCLCTT2020IASLC_LCTT_241;
- ||| Enrollment change, Trial completion date, Trial primary completion date, PD(L)-1 Biomarker, Metastases: The Drug Rediscovery Protocol (DRUP Trial) (clinicaltrials.gov) - Feb 17, 2020
P2, N=950, Recruiting, Sponsor: The Netherlands Cancer Institute
By arrangement of treatment such as treatment sequence of ALK-TKI and chemotherapy regimen, it might be possible to obtain a treatment outcome almost equivalent to those of clinical trials even in real clinical practice. N=400 --> 950 | Trial completion date: Dec 2019 --> Dec 2022 | Trial primary completion date: Aug 2019 --> Aug 2022
- Alecensa (alectinib) / Roche
Alectinib in patients with ALK-positive advanced non-small cell lung cancer as first-line or sequential treatment in China :a multicentric real-world study (Hall 1) - Feb 15, 2020 - Abstract #ELCC2020ELCC_402;
- | Journal: Treatment of anaplastic lymphoma kinase-positive non-small cell lung cancer: update and perspectives. (Pubmed Central) - Feb 14, 2020
Patients with metastatic, anaplastic lymphoma kinase-rearranged nonsmall cell lung cancer should be managed by interdisciplinary expert teams. New drugs with enhanced brain activity are available, and some patients may benefit from local therapies.
- | Alecensa (alectinib) / Roche
Journal, IO Biomarker: Overexpression of CD 133 and BCL-2 in non-small cell lung cancer with neuroendocrine differentiation after transformation in ALK rearrangement-positive adenocarcinoma. (Pubmed Central) - Feb 14, 2020
We report a case of transformation of ALK rearrangement-positive adenocarcinoma to NSCLC with neuroendocrine differentiation during alectinib therapy...The immunohistochemical findings of these markers associated with cancer stem-like cells and/or neuroendocrine differentiation suggest that cancer stem cells play a role in the mechanisms of histological transformation and acquired resistance of ALK rearrangement-positive cancer. To our knowledge, this is the first report to suggest an association between cancer stem-like cells and histological transformation in ALK rearrangement-positive lung cancer.
- || Alecensa (alectinib) / Roche
Clinical, Journal: Durable response to the ALK inhibitor alectinib in inflammatory myofibroblastic tumor of the head and neck with a novel SQSTM1-ALK fusion: a case report. (Pubmed Central) - Feb 9, 2020
Notably, the patient exhibited a marked response to alectinib treatment and has sustained for 17 months following systemic therapy initiation without significant adverse events. This report highlights the possibility of alectinib being a reasonable option for advanced IMT with the SQSTM1-ALK fusion.
- | Preclinical, Journal: Development and validation of a liquid chromatography-tandem mass spectrometry assay for nine oral anticancer drugs in human plasma. (Pubmed Central) - Feb 8, 2020
All other compounds were stable in the biomatrix. The described TDM method was successfully validated and applied for TDM in patients treated with these KIs.
- || Alunbrig (brigatinib) / Takeda, Tagrisso (osimertinib) / AstraZeneca, Alecensa (alectinib) / Roche
We sell alectinib, brigatinib, osimertinib. If you need to contact me in WhatsApp: +8801922101028 (Twitter) - Feb 8, 2020
- || Alecensa (alectinib) / Roche
Clinical, P2 data, Journal: Time To Response In Patients With Advanced Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small-Cell Lung Cancer (NSCLC) Receiving Alectinib In The Phase II NP28673 And NP28761 Studies. (Pubmed Central) - Feb 6, 2020
P1/2
Similar results were observed regardless of measurable/non-measurable disease. These data suggest that alectinib achieves a rapid response in patients, both systemically and in the CNS.
- || Alecensa (alectinib) / Roche
Trial completion date, Trial primary completion date, Metastases: Treatment Registry of Alectinib in Anaplastic Lymphoma Kinase (ALK)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Korea (clinicaltrials.gov) - Feb 6, 2020
P=N/A, N=167, Recruiting, Sponsor: Hoffmann-La Roche
These data suggest that alectinib achieves a rapid response in patients, both systemically and in the CNS. Trial completion date: Mar 2021 --> Dec 2021 | Trial primary completion date: Mar 2021 --> Dec 2021
- | Enrollment open, Metastases: MegaMOST: A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/characteristics in Advanced / Metastatic Tumors. (clinicaltrials.gov) - Feb 6, 2020
P2, N=100, Recruiting, Sponsor: Centre Leon Berard
Trial completion date: Mar 2021 --> Dec 2021 | Trial primary completion date: Mar 2021 --> Dec 2021 Not yet recruiting --> Recruiting
- ||| Alecensa (alectinib) / Roche
Trial completion date: ALINA: A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer (clinicaltrials.gov) - Feb 5, 2020
P3, N=255, Recruiting, Sponsor: Hoffmann-La Roche
Not yet recruiting --> Recruiting Trial completion date: Aug 2026 --> Nov 2026
- |||| Trial primary completion date, Tumor mutational burden, IO Companion diagnostic, PD(L)-1 Biomarker, PD(L)-1 companion diagnostic, Metastases: BFAST: A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - Jan 27, 2020
P2/3, N=580, Recruiting, Sponsor: Hoffmann-La Roche
Trial completion date: Aug 2026 --> Nov 2026 Trial primary completion date: Jun 2019 --> Sep 2020
- Alecensa (alectinib) / Roche
First description of an unknown anaplastic lymphoma kinase (ALK) exon 23 mutation following treatment with Alectinib in a patient with metastatic non-small cell lung cancer (NSCLC) (atrium) - Jan 25, 2020 - Abstract #DKK2020DKK_2462;
- Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
Final Progression-Free Survival (PFS), Updated Overall Survival (OS), And Safety Data from the Global, Randomized, Phase 3 Alex Study of Alectinib (ALC) Versus Crizotinib (CRZ) in Untreated Advanced ALK+ Non-Small Cell Lung Cancer (NSCLC) (atrium) - Jan 25, 2020 - Abstract #DKK2020DKK_2457;
P3
This final updated PFS analysis confirms the superior efficacy and favorable tolerability of ALC v CRZ in pts with untreated ALK+ NSCLC. OS data remain immature.
- |||| Imfinzi (durvalumab) / AstraZeneca, BMS, Tagrisso (osimertinib) / AstraZeneca, Alecensa (alectinib) / Roche
Next-Generation Sequencing: Thanks! My personal list: 1. Immunotherapy 1st line 2. Durvalumab in stage III 3. Osimertinib and alectinib 4. New drugable targets (NGS) 5. Screening (Twitter) - Jan 25, 2020
- |||| Monotherapy: Here’s my starter: 1. Mortality benefit with CT screening 2. Durvalumab OS benefit in PACIFIC 3. IO monotherapy: KN024 & 042, IMP110 4. chemo-IO combos (KN189 & 407) 5. Next gen TKIs upfront eg alectinib, brigatinib, osimertinib #lcsm (Twitter) - Jan 25, 2020
- || Alecensa (alectinib) / Roche
Clinical, Journal: Alectinib Resistance in ALK-rearranged Lung Cancer by Dual Salvage Signaling in a Clinically Paired Resistance Model. (Pubmed Central) - Jan 25, 2020
OS data remain immature. This study demonstrates the feasibility to elucidate personalized drug-resistance mechanisms from individual patient samples.
- Alecensa (alectinib) / Roche
Detection of ALK Gene Rearrangements in Lung Adenocarcinomas: Assessment of Concordance Among IHC, FISH, RNA ISH, and NGS Testing Modalities (LACC West Exhibit Hall A: Moderated Poster Room 3, Poster Board Number: 250) - Jan 24, 2020 - Abstract #USCAP2020USCAP_3044;
The one discordance was between ALK IHC and ALK FISH/RNA ISH results. RNA NGS can detect the specific ALK rearrangement, including novel ones, which may help identify patients who may or may not benefit from targeted therapy.
- Alecensa (alectinib) / Roche
Detection of ALK Gene Rearrangements in Lung Adenocarcinomas: Assessment of Concordance Among IHC, FISH, RNA ISH, and NGS Testing Modalities (LACC West Exhibit Hall A, Poster Board Number: 250) - Jan 24, 2020 - Abstract #USCAP2020USCAP_812;
The one discordance was between ALK IHC and ALK FISH/RNA ISH results. RNA NGS can detect the specific ALK rearrangement, including novel ones, which may help identify patients who may or may not benefit from targeted therapy.
- | Alecensa (alectinib) / Roche
Journal: Leptomeningeal recurrence after long-term alectinib therapy for non-small cell lung cancer harboring an EML4-ALK fusion protein. (Pubmed Central) - Jan 23, 2020
Reintroduction of standard-dose alectinib therapy resolved the lesion again. Our findings suggest that ALK-tyrosine kinase inhibitor therapy should be continued in patients showing a long-term complete response, unless intolerable toxicities are present, and that rechallenge treatment with alectinib may represent a therapeutic option for central nervous system metastases.
- || Alunbrig (brigatinib) / Takeda
Enrollment closed, Metastases: ALTA-2: A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib (clinicaltrials.gov) - Jan 15, 2020
P2, N=104, Active, not recruiting, Sponsor: Ariad Pharmaceuticals
Our findings suggest that ALK-tyrosine kinase inhibitor therapy should be continued in patients showing a long-term complete response, unless intolerable toxicities are present, and that rechallenge treatment with alectinib may represent a therapeutic option for central nervous system metastases. Recruiting --> Active, not recruiting
- |||| Alecensa (alectinib) / Roche
Clinical: No alectinib available for 1st line ALK positive NSCLC in China? Global SoC surely? (Twitter) - Jan 15, 2020
- || Alecensa (alectinib) / Roche
Clinical, Journal: Model-Informed Drug Development Approach to Expedite Approval: Case of Alectinib in First-Line Anaplastic Lymphoma Kinase + Non-Small Cell Lung Cancer. (Pubmed Central) - Jan 11, 2020
Recruiting --> Active, not recruiting No abstract available
- | Journal: Epithelial-to-mesenchymal transition is a mechanism of ALK inhibitor resistance in lung cancer independent of ALK mutation status. (Pubmed Central) - Jan 2, 2020
Pre-treatment with the histone deacetylase (HDAC) inhibitor quisinostat overcame this resistance by reverting EMT in vitro and in vivo. These findings indicate that HDAC inhibitor pre-treatment followed by a new ALK inhibitors may be useful to circumvent resistance constituted by coexistence of resistance mutations and EMT in the heterogeneous tumor.
- || selpercatinib (LOXO-292) / Eli Lilly, Alecensa (alectinib) / Roche
Clinical, Journal: Selective RET Kinase Inhibition for Patients with RET-Altered Cancers. (Pubmed Central) - Dec 25, 2019
A second patient with KIF5B-RET fusion-positive lung cancer, acquired resistance to alectinib and symptomatic brain metastases experienced a dramatic response in the brain, and her symptoms resolved. These results provide proof-of-concept of the clinical actionability of RET alterations, and identify selective RET inhibition by LOXO-292 as a promising treatment in heavily pretreated, multikinase inhibitor-experienced patients with diverse RET-altered tumors.
- | Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis, Alecensa (alectinib) / Roche
Retrospective data, Journal: Meta-analysis comparing incidence of grade 3-4 neutropenia with ALK inhibitors and chemotherapy in patients with non-small-cell lung cancer. (Pubmed Central) - Dec 23, 2019
Probabilities of developing grade 3-4 neutropenia were 6.56 and 14.19%, respectively; no significant difference was found. In patients with non-small-cell lung cancer, incidence of grade 3-4 neutropenia with ALK-targeted therapy is not significantly different compared with chemotherapy.
- || Review, Journal: New generation anaplastic lymphoma kinase inhibitors. (Pubmed Central) - Dec 22, 2019
Some of them were approved after the failure of crizotinib (ceritinib, alectinib, brigatinib and lorlatinib) and in first line setting (ceritinib, alectinib and brigatinib) while others are still under evaluation for TKI-naive patients such as lorlatinib, ensartinib and entrectinib. In this review we will discuss the most recent results of new TKIs in order to describe a fast growing therapeutic landscape in this setting.