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39 Diseases | | 1 Product |
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- | Qi Xinke (iruplinalkib) / Qilu Pharma
Journal, Metastases: Chinese expert consensus on iruplinalkib for the treatment of locally advanced or metastatic ALK-positive non-small cell lung cancer (2024 edition) (Pubmed Central) - Mar 22, 2024
On January 16, 2024, the NMPA approved iruplinalkib for the first-line treatment of locally advanced or metastatic ALK-positive NSCLC patients. In order to better understand the efficacy and safety of iruplinalkib, and facilitate more rationally clinical application of iruplinalkib, the Medical Oncology Branch of China International Exchange and Promotive Association for Medical and Health Care and the Chinese Association for Clinical Oncologists co-organized experts to compile the "Chinese expert consensus on iruplinalkib for the treatment of locally advanced or metastatic ALK-positive non-small cell lung cancer (2024 edition)".
- || Ensacove (ensartinib) / Xcovery, Xalkori (crizotinib) / Pfizer
P2 data, Journal, Circulating tumor DNA: Updated overall survival and circulating tumor DNA analysis of ensartinib for crizotinib-refractory ALK-positive NSCLC from a phase II study. (Pubmed Central) - Feb 29, 2024
P2
Ensartinib led to a favorable OS in patients with advanced, crizotinib-resistant, and ALK-positive NSCLC. Quantification of ctDNA levels also provided valuable prognostic information for risk stratification.
- | Ensacove (ensartinib) / Xcovery, Avastin (bevacizumab) / Roche
Phase classification, Combination therapy: Ensartinib, Carboplatin, Pemetrexed and Bevacizumab for the Treatment of Stage IIIC or IV or Recurrent ALK-Positive Non-small Cell Lung Cancer (clinicaltrials.gov) - Feb 22, 2024
P1, N=12, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
Quantification of ctDNA levels also provided valuable prognostic information for risk stratification. Phase classification: P1b --> P1
- || Review, Journal: Anaplastic Lymphoma Kinase (ALK) Inhibitors Show Activity in Colorectal Cancer With ALK Rearrangements: Case Series and Literature Review. (Pubmed Central) - Feb 21, 2024
The patient experienced disease progression with an acquired ALK G1202R resistance mutation that responded well to lorlatinib...However, the patient responded remarkably well to alectinib. Our report emphasizes the importance of gene detection in the treatment of malignant tumors, and the significance of ALK mutations in CRC.
- | Ensacove (ensartinib) / Xcovery
Trial completion date, Trial primary completion date: Treating Patients With Melanoma and ALK Alterations With Ensartinib (clinicaltrials.gov) - Feb 15, 2024
P2, N=18, Active, not recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Our report emphasizes the importance of gene detection in the treatment of malignant tumors, and the significance of ALK mutations in CRC. Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
- | Journal, Metastases: China expert recommendations on anaplastic lymphoma kinase-tyrosine kinase inhibitors treatment for advanced non-small cell lung cancer (2024 edition) (Pubmed Central) - Feb 10, 2024
To standardize the application of ALK-TKI, the Chinese Association for Clinical Oncologists and the Medical Oncology Branch of China International Exchange and Promotive Association for Medical and Health Care has organized experts to compile the " China expert recommendations on anaplastic lymphoma kinase-tyrosine kinase inhibitors treatment for advanced non-small cell lung cancer (2024 edition)". This treatment expert recommendation provides recommendations in four aspects, encompassing ALK fusion testing, ALK-TKI targeted therapy, ALK-TKI adverse events management, and patient post-treatment follow-up, thus serving as a valuable reference for the standardized treatment of Chinese advanced ALK fusion-positive NSCLC.
- | Ensacove (ensartinib) / Xcovery
Retrospective data, Journal, Metastases: A retrospective study of ensartinib-treated ALK-positive locally advanced or metastatic NSCLC patients in China. (Pubmed Central) - Jan 19, 2024
The most common TRAE was rash (21.1%) and no TRAE led to death. Ensartinib is active and well tolerated for ALK-positive NSCLC patients in real-world clinical settings.
- || Retrospective data, Review: Comparing efficacy and safety of upfront treatment strategies for anaplastic lymphoma kinase-positive non-small cell lung cancer: a network meta-analysis. (Pubmed Central) - Jan 12, 2024
Based on the network meta-analysis, alectinib and lorlatinib emerged as the most promising upfront treatment options. These treatments provide prolonged disease control while maintaining an acceptable safety profile.
- | Ensacove (ensartinib) / Xcovery
Journal, Metastases: Ensartinib is effective in the treatment of advanced non-small-cell lung cancer with MET amplification after multi-line ALK-TKIs resistance: a case report. (Pubmed Central) - Jan 5, 2024
Among these, the MET pathway is one of the signaling pathways that has recently been extensively studied, and activation of this pathway is one of the mechanisms of ALK-independent drug resistance. Here, we report a successful case of an advanced NSCLC patient who was resistant to treatment with ALK TKIs and developed MET amplification, who achieved 23 months of progression-free survival after post-line treatment with ensartinib.
- || Review, Journal: Management of Brain Metastases: A Review of Novel Therapies. (Pubmed Central) - Nov 28, 2023
Novel systemic therapies with intracranial utility include new anaplastic lymphoma kinase inhibitors like brigatinib and ensartinib; selective "rearranged during transfection" inhibitors like selpercatinib and pralsetinib; B-raf proto-oncogene inhibitors like encorafenib and vemurafenib; Kirsten rat sarcoma viral oncogene inhibitors like sotorasib and adagrasib; ROS1 gene rearrangement (ROS1) inhibitors, anti-neurotrophic tyrosine receptor kinase agents like larotrectinib and entrectinib; anti-human epidermal growth factor receptor 2/epidermal growth factor receptor exon 20 agent like poziotinib; and antibody-drug conjugates like trastuzumab-emtansine and trastuzumab-deruxtecan. This review highlights the modern multidisciplinary management of BM, emphasizing the integration of systemic and local therapies.
- | Biomarker, Trial completion date: NRG-LU003: Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer (clinicaltrials.gov) - Nov 21, 2023
P2, N=10, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
This review highlights the modern multidisciplinary management of BM, emphasizing the integration of systemic and local therapies. Trial completion date: Apr 2024 --> Sep 2024
- | Ensacove (ensartinib) / Xcovery
Enrollment open: Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer (clinicaltrials.gov) - Oct 10, 2023
P2, N=80, Recruiting, Sponsor: Hebei Medical University Fourth Hospital
Trial completion date: Apr 2024 --> Sep 2024 Not yet recruiting --> Recruiting
- || Retrospective data, Review, Journal, Metastases: Comparative safety of anaplastic lymphoma kinase tyrosine kinase inhibitors in advanced anaplastic lymphoma kinase-mutated non-small cell lung cancer: Systematic review and network meta-analysis. (Pubmed Central) - Sep 19, 2023
The toxicity spectra of ALK-TKIs differed. Alectinib might be the safest ALK-TKI drug according to the combined evidence of grades 3-4 AEs and the combined incidence.
- | Ensacove (ensartinib) / Xcovery
Journal: Oral Ensartinib is effective in patients with co-existing ALK fusion mutations and point mutations. (Pubmed Central) - Sep 7, 2023
Alectinib might be the safest ALK-TKI drug according to the combined evidence of grades 3-4 AEs and the combined incidence. No abstract available
- || Ensacove (ensartinib) / Xcovery
Trial completion, Enrollment change: Ensartinib in Non-small Cell Lung Cancer Patients With Positive ALK (clinicaltrials.gov) - Aug 21, 2023
P1, N=48, Completed, Sponsor: Betta Pharmaceuticals Co., Ltd.
No abstract available Recruiting --> Completed | N=24 --> 48
- || Ensacove (ensartinib) / Xcovery
Enrollment closed: X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib (clinicaltrials.gov) - Aug 16, 2023
P2, N=152, Active, not recruiting, Sponsor: Betta Pharmaceuticals Co., Ltd.
Recruiting --> Completed | N=24 --> 48 Recruiting --> Active, not recruiting
- | Ensacove (ensartinib) / Xcovery
Biomarker, Journal, Next-generation sequencing: Identification of a novel RSRC1-ALK (R6: A20) fusion using next-generation sequencing technique. (Pubmed Central) - Aug 12, 2023
He was in a state of progression-free survival for at least 24 months in follow-up with no complications. NGS can be used for exploring treatment options for NSCLC patients with ALK fusion.
- ||| Ensacove (ensartinib) / Xcovery
Enrollment open, Trial completion date: X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib (clinicaltrials.gov) - Jul 27, 2023
P2, N=152, Recruiting, Sponsor: Betta Pharmaceuticals Co., Ltd.
NGS can be used for exploring treatment options for NSCLC patients with ALK fusion. Unknown status --> Recruiting | Trial completion date: Dec 2018 --> Dec 2023
- Ensacove (ensartinib) / Xcovery
Efficacy and safety of ensartinib in ALK-positive non-small cell lung cancer patients with brain metastases: A multicenter, open-label, single-arm, phase II study () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2863;
P2
Table: 1370P Conclusions Ensartinib showed promising intracranial efficacy with high blood-brain barrier penetration and a tolerable safety profile in ALK+ NSCLC pts with BM. Study is ongoing and final results will be presented in future.
- Lorbrena (lorlatinib) / Pfizer
Loss of EPHA2 Induces Primary Lorlatinib Resistance Through Sustained MAPK Activation (Exhibit Hall) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_2316;
Loss of EPHA2 leads to Lorlatinib resistance due to the lack of negative feedback to MAPK. These findings serve as supportive evidence for the selection of appropriate candidates for Lorlatinib treatment.
- Mechanisms of Acquired Resistance to ALK Inhibitors Using Plasma Sequencing - Preliminary Data from the ATORG004 Study (Exhibit Hall) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_2307;
DDR and cell cycle gene alterations were commonly detected and may represent previously unreported acquired resistance alterations. Comprehensive ctDNA NGS analysis at progression may help detect novel resistance alterations in patients on ALK inhibitors.
- Ensacove (ensartinib) / Xcovery, Lorbrena (lorlatinib) / Pfizer, Alecensa (alectinib) / Roche
Identifying Biomarkers of Response to Ensartinib, Lorlatinib, and Alectinib in an ALK+ Non-Small Cell Lung Cancer Preclinical Model (ResCu) (Exhibit Hall) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_1945;
Genetic background significantly influenced which ALKi exhibited the most durable response. We identified 124 resistance changes associated with ALKi, 109 of which are unique to one of the three ALKi tested.
- Ensacove (ensartinib) / Xcovery
NEOEAST: A Phase II Study of Ensartinib as Neoadjuvant Therapy for Stage II-IIIB ALK-rearranged Non-small Cell Lung Cancer (Exhibit Hall) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_1506;
P2
Secondary endpoints include the pathologic complete response, investigator-assessed objective response rate per RECIST 1.1, disease-free survival, overall survival, and safety as assessed by the incidence of adverse events (CTCAE 5.0). Enrollment began in May 2022 and is ongoing; completion of primary data collection is anticipated in 2024.
- || Review, HEOR, Cost-effectiveness, Cost effectiveness, Metastases: A Systematic Review of the Cost-Effectiveness Analyses of Anaplastic Lymphoma Kinase (ALK) Inhibitors in Patients with Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC). (Pubmed Central) - Jul 7, 2023
The findings summarized available evidence on cost effectiveness of ALK inhibitors for the treatment of patients with locally advanced or metastatic ALK+ NSCLC across lines of treatment settings and generated a valuable overview of analytical approaches utilized to support future economic analyses. To help further inform treatment and policy decisions, this review emphasizes the need for comparative cost effectiveness of multiple ALK inhibitors simultaneously using real-world data sources with broad representation of settings.
- || Review, Journal, Adverse drug reaction: Expert consensus of management of adverse drug reactions with anaplastic lymphoma kinase tyrosine kinase inhibitors. (Pubmed Central) - Jul 3, 2023
The therapeutic use of this class of medications still carries some risk because there are currently no pertinent guidelines or consensus recommendations for managing ADRs caused by ALK-TKIs in China. In order to improve the clinical management of ADRs with ALK-TKIs, the Chinese Society of Clinical Oncology (CSCO) Non-small Cell Lung Cancer Professional Committee led the discussion and summary of the incidence, diagnosis and grading standards, and prevention and treatment of ADRs caused by ALK-TKIs.
- || Lorbrena (lorlatinib) / Pfizer
Preclinical, Review, Journal, Metastases: From preclinical efficacy to 2022 updated CROWN trial, lorlatinib is the preferred 1-line treatment of advanced ALK+ NSCLC. (Pubmed Central) - Jun 12, 2023
In order to improve the clinical management of ADRs with ALK-TKIs, the Chinese Society of Clinical Oncology (CSCO) Non-small Cell Lung Cancer Professional Committee led the discussion and summary of the incidence, diagnosis and grading standards, and prevention and treatment of ADRs caused by ALK-TKIs. Six ALK TKIs (crizotinib, ceritinib, alectinib, brigatinib, lorlatinib, ensartinib) have received first-line treatment indication of advanced ALK+
- || Clinical, Review, Journal: Sustained Improvement in the Management of Patients with Non-Small-Cell Lung Cancer (NSCLC) Harboring ALK Translocation: Where Are We Running? (Pubmed Central) - May 30, 2023
Several randomized trials have proven that ALK inhibitors (ALK-Is) have greater efficacy with respect to platinum-based chemotherapy and that second/third generation ALK-Is are better than crizotinib in terms of improvements in median progression-free survival and brain metastases management...This review summarizes first-line randomized clinical trials of several ALK-Is and the management of brain metastases with a focus on ALK-I resistance mechanisms. The last section addresses future developments and challenges.
- || Ensacove (ensartinib) / Xcovery, Lorbrena (lorlatinib) / Pfizer, Rozlytrek (entrectinib) / Roche
Review, Journal: An updated patent review of anaplastic lymphoma kinase inhibitors (2018-2022). (Pubmed Central) - May 29, 2023
Herein, we will discuss the last five years results of novel ALK inhibitors published in patent literatures. It may contribute impactful lessons regarding the discovery and development of novel ALK inhibitors to overcome the resistance issue.
- Adcetris (brentuximab vedotin) / Seagen, Takeda, Alunbrig (brigatinib) / Takeda
BRIGATINIB IN PATIENTS WITH ALK-POSITIVE ANAPLASTIC LARGE CELL LYMPHOMA WHO HAVE FAILED BRENTUXIMAB VEDOTIN (Poster area) - May 12, 2023 - Abstract #EHA2023EHA_1452;
These results should be confirmed in prospective studies. Relapsed lymphoma, Kinase inhibitor, ALK/ALCL
- | Ensacove (ensartinib) / Xcovery, Alecensa (alectinib) / Roche
Journal: Bayesian analysis supports the role of alectinib and ensartinib for ALK-positive non-small cell lung cancer. (Pubmed Central) - May 3, 2023
Relapsed lymphoma, Kinase inhibitor, ALK/ALCL No abstract available
- | Ensacove (ensartinib) / Xcovery, Tagrisso (osimertinib) / AstraZeneca
Biomarker, Journal, MSi-H Biomarker, PD(L)-1 Biomarker, IO biomarker: Genomic and transcriptomic insights into the precision treatment of pulmonary enteric adenocarcinoma. (Pubmed Central) - May 3, 2023
PD-L1 expression and KRAS mutation type may be used as predictive biomarkers for immunotherapy in PEAC. This study provided both theoretical basis and clinical evidence for PEAC.
- Ensacove (ensartinib) / Xcovery, Lorbrena (lorlatinib) / Pfizer, Alecensa (alectinib) / Roche
Differentiating ensartinib from lorlatinib and alectinib for first line use in an ALK+ non-small cell lung cancer preclinical model (ResCu). () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6357;
In one of the two genetic background ensartinib response was durable for greater than 42 days compared to 14 days with alectinib and lorlatinib. Alectinib led to the most cross-resistance to other ALKi while lorlatinib led to the most cross-resistance to other drug classes in both backgrounds.
- || Ensacove (ensartinib) / Xcovery
PK/PD data, Journal: Development of high-performance liquid chromatography tandem mass spectrometry assay for quantitation of ensartinib in human plasma and its application to a pharmacokinetics study in Chinese patients. (Pubmed Central) - Apr 19, 2023
The Extraction recovery, matrix effect, selectivity, stability were also validated and all satisfactory. Finally, the validated method was successfully applied in a phase I clinical study of ensartinib in Chinese subjects with advanced ALK-positive NSCLC.
- | Ensacove (ensartinib) / Xcovery
Journal: Potent antitumor activity of ensartinib in MET exon 14 skipping-mutated non-small cell lung cancer. (Pubmed Central) - Apr 17, 2023
Ensartinib also potently inhibited the viability of PDOs. Overall, Ensartinib exhibited substantial antitumor effects against METex14 mutant NSCLCs in preclinical and clinical trials, with relatively low peripheral edema rates.
- | Biomarker, Enrollment change, Trial completion date: NRG-LU003: Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer (clinicaltrials.gov) - Apr 14, 2023
P2, N=10, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
Overall, Ensartinib exhibited substantial antitumor effects against METex14 mutant NSCLCs in preclinical and clinical trials, with relatively low peripheral edema rates. N=660 --> 10 | Trial completion date: May 2023 --> Apr 2024
- || Retrospective data, Review, Journal: Efficacy and safety of anaplastic lymphoma kinase inhibitors for non-small cell lung cancer: A systematic review and network meta-analysis. (Pubmed Central) - Apr 4, 2023
N=660 --> 10 | Trial completion date: May 2023 --> Apr 2024 These results indicated that alectinib could be associated with the best therapeutic efficacy and well-tolerance AEs in the treatment of ALK-positive NSCLC.
- | Ensacove (ensartinib) / Xcovery
Journal: Radiomic-signature changes after early treatment improve the prediction of progression-free survival in patients with advanced anaplastic lymphoma kinase-positive non-small cell lung cancer. (Pubmed Central) - Mar 21, 2023
The combination of clinical and radiomic features provided a prognostic value for survival and progression in patients with NSCLC receiving ensartinib. Radiomic-signature changes after early treatment could be more valuable than those at baseline alone.
- NVL-655 / Nuvalent, Alecensa (alectinib) / Roche
Preclinical intracranial activity of NVL-655 in an alectinib-resistant patient-derived model harboring EML4-ALK fusion with G1202R mutation (Section 20; Poster Board #19) - Mar 14, 2023 - Abstract #AACR2023AACR_6212;
P1/2
Using a xenograft model derived from an alectinib-relapsed patient, we showed that NVL-655 had high intracranial activity against brain tumors bearing the ALK G1202R mutation that confers resistance to multiple ALK TKIs. NVL-655 is being evaluated in a Phase 1/2 clinical trial for patients with advanced NSCLC and other solid tumors harboring ALK rearrangement or activating ALK mutation (ALKOVE-1): NCT05384626.
- || Review, Journal, Metastases: Optimal first-line treatment for metastatic ALK+ non-small cell lung cancer-a narrative review. (Pubmed Central) - Mar 10, 2023
This review serves as a resource summarizing data from key clinical trials with ALK inhibitors to aid in decision making when tailoring treatment for patients. Future research in the field includes real world analysis of efficacy and toxicity of next-generation ALK-inhibitors, identification of mechanisms of tumor persistence and acquired resistance, development of novel ALK inhibitors, and use of ALK-TKIs in earlier stage disease.
- | Ensacove (ensartinib) / Xcovery
Journal, Metastases: First case report of ensartinib in a patient with metastatic ALK rearranged lung cancer with ALK I1171N mutation: a case report. (Pubmed Central) - Mar 7, 2023
Future research in the field includes real world analysis of efficacy and toxicity of next-generation ALK-inhibitors, identification of mechanisms of tumor persistence and acquired resistance, development of novel ALK inhibitors, and use of ALK-TKIs in earlier stage disease. This treatment may provide a new therapeutic strategy for ALK TKIs resistant patients, especially in position 1171 of ALK exon20.
- || Retrospective data, Review, Journal, Metastases: Comparative Efficacy of ALK Inhibitors for Treatment-Na (Pubmed Central) - Feb 12, 2023
While lorlatinib was superior to brigatinib for PFS in the overall patient population, no significant difference between the two was found in the subgroup of patients with CNS metastases. These results can serve as a foundation for basic, clinical, and translational research and guide clinical oncologists in developing individualized treatment strategies for patients with ALK-p, ALK inhibitor-naive advanced NSCLC.
- ||| Ensacove (ensartinib) / Xcovery
Trial completion date: eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients (clinicaltrials.gov) - Feb 9, 2023
P3, N=290, Active, not recruiting, Sponsor: Xcovery Holding Company, LLC
These results can serve as a foundation for basic, clinical, and translational research and guide clinical oncologists in developing individualized treatment strategies for patients with ALK-p, ALK inhibitor-naive advanced NSCLC. Trial completion date: Dec 2022 --> Dec 2023
- | Ensacove (ensartinib) / Xcovery
Trial completion date, Trial primary completion date: Treating Patients With Melanoma and ALK Alterations With Ensartinib (clinicaltrials.gov) - Feb 8, 2023
P2, N=18, Active, not recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Trial completion date: Dec 2022 --> Dec 2023 Trial completion date: Jan 2023 --> Jan 2024 | Trial primary completion date: Jan 2023 --> Jan 2024
- || Clinical, Retrospective data, Review, Journal, Metastases: Efficacy and safety of first-line treatments for patients with advanced anaplastic lymphoma kinase mutated, non-small cell cancer: A systematic review and network meta-analysis. (Pubmed Central) - Feb 7, 2023
Today, the treatment of lung cancer has moved into the era of precision therapy. In this article, we use a statistical approach to compare the efficacy and safety of targeted drugs that have been used in the first-line treatment of anaplastic lymphoma kinase mutations to improve the reference for clinicians to make treatment decisions in the real world.
- | Ensacove (ensartinib) / Xcovery
Journal, Metastases: Novel LINC01923-anaplasticlymphoma kinase rearrangement identified in advanced lung adenocarcinoma with durable response to ensartinib: a case report. (Pubmed Central) - Feb 3, 2023
The patient was treated successfully with ensartinib leading to a progression-free survival of 6 months (and counting). This is the first report on one lung adenocarcinoma patient with a novel LINC01923-ALK fusion beneficial from ensartinib, which provides more knowledge for ALK fusion spectrum.
- || Ensacove (ensartinib) / Xcovery
Review, Journal: Neoadjuvant target therapy with ensartinib in lung adenocarcinoma with EML4-ALK fusion variant: a case report and literature review. (Pubmed Central) - Feb 3, 2023
To our knowledge, few patients with ALK-positive NSCLC had received neoadjuvant treatment with ensartinib. Findings in this patient may widen indications for neoadjuvant target therapy in the treatment of resectable stage II-IIIA ALK-positive NSCLC.
- Ensacove (ensartinib) / Xcovery, Lorbrena (lorlatinib) / Pfizer, Alecensa (alectinib) / Roche
Differentiating Ensartinib from Lorlatinib and Alectinib for First Line Use in an ALK+ Non-small Cell Lung Cancer Preclinical Model (ResCu) (Wedgewood Ballroom) - Jan 28, 2023 - Abstract #IASLCTTLC2023IASLC_TTLC_160;
Alectinib led to the most cross-resistance to other ALKi while lorlatinib led to the most cross-resistance to other drug classes in both backgrounds. Biomarkers of ALKi escape and cross-resistance were derived from RNA-seq, and we are currently validating these alterations against clinical samples.
- || Ensacove (ensartinib) / Xcovery
P1 data, Journal, Metastases: Ensartinib in advanced ALK-positive non-small cell lung cancer: a multicenter, open-label, two-staged, phase 1 trial. (Pubmed Central) - Jan 18, 2023
P1
Ensartinib was well tolerated under 225 mg (MTD) and demonstrated promising anti-tumor activity in ALK+ NSCLC patients, including those with CNS metastases and those previously TKI-treated. ClinicalTrials.gov NCT02959619.
- | Ensacove (ensartinib) / Xcovery, Avastin (bevacizumab) / Roche
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy: Ensartinib, Carboplatin, Pemetrexed and Bevacizumab for the Treatment of Stage IIIC or IV or Recurrent ALK-Positive Non-small Cell Lung Cancer (clinicaltrials.gov) - Jan 6, 2023
P1b, N=12, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
ClinicalTrials.gov NCT02959619. Recruiting --> Active, not recruiting | Trial completion date: Sep 2022 --> Sep 2027 | Trial primary completion date: Sep 2022 --> Sep 2027
- | Ensacove (ensartinib) / Xcovery, Xalkori (crizotinib) / Pfizer
Journal: Pharmacological targeting of the receptor ALK inhibits tumorigenicity and overcomes chemoresistance in pancreatic ductal adenocarcinoma. (Pubmed Central) - Dec 27, 2022
Consequently, ALK inhibition delayed tumor relapse after chemotherapy in vivo by effectively decreasing the content of PaCSCs. In summary, our results demonstrate that targeting the MDK/PTN-ALK axis with clinically-approved inhibitors impairs in vivo tumorigenicity and chemoresistance in PDAC suggesting a new treatment approach to improve the long-term survival of PDAC patients.