Alecensa (alectinib) / Roche 
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 13 Diseases   52 Trials   52 Trials   3235 News 


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  • ||||||||||  Trial initiation date, Tumor mutational burden:  CRAFT: The NCT-PMO-1602 Phase II Trial (clinicaltrials.gov) -  Jun 9, 2021   
    P2,  N=175, Not yet recruiting, 
    Healthcare costs and resource utilization were significantly higher for patients with ALK + NSCLC with BM versus no BM. Initiation date: Apr 2021 --> Aug 2021
  • ||||||||||  [VIRTUAL] Optimal Therapeutic Approaches for Patients with Genomic Aberrations beyond EGFR, ALK and ROS1 () -  Jun 5, 2021 - Abstract #ASCO2021ASCO_5880;    
    Initiation date: Apr 2021 --> Aug 2021 Design, eligibility criteria and key findings from the Phase II VISION trial leading to the recent FDA approval of tepotinib for patients with metastatic NSCLC harboring MET exon 14 skipping alterations Rationale for the design of the ongoing Phase II NAUTIKA1 neoadjuvant and adjuvant study of alectinib, entrectinib, vemurafenib/cobimetinib or pralsetinib for patients with resectable Stage II-III NSCLC harboring ALK, ROS1, NTRK, BRAF V600 or RET molecular alterations Key efficacy and safety outcomes from the Phase II GEOMETRY mono-1 trial supporting the FDA approval of capmatinib for patients with MET exon 14 mutation-positive metastatic NSCLC Practical integration and optimal sequencing of capmatinib and tepotinib into current clinical management of patients with advanced NSCLC harboring MET exon 14 skipping alterations Available safety and efficacy results from the LIBRETTO-001 and ARROW trials leading to the FDA approvals of selpercatinib and pralsetinib for patients with RET fusion-driven NSCLC; optimal integration into clinical practice Design, eligibility and key endpoints of the Phase III LIBRETTO-431 and AcceleRET Lung studies assessing selpercatinib and pralsetinib, respectively, compared to first-line chemotherapy with or without pembrolizumab in patients with treatment-naïve RET fusion-positive advanced NSCLC Frequency and clinical impact of HER2 overexpression or mutations in NSCLC; key efficacy and safety findings from the Phase II DESTINY-Lung01 study evaluating trastuzumab deruxtecan in HER2-overexpressing or mutated NSCLC FDA breakthrough therapy designation and potential nonprotocol role of trastuzumab deruxtecan in patients with HER2-positive metastatic NSCLC Clinical impact of HER3 upregulation as a mechanism of resistance to EGFR tyrosine kinase inhibitors; early efficacy and safety findings with patritumab deruxtecan in a Phase I trial for previously treated patients with EGFR mutation-positive unresectable or metastatic NSCLC Ongoing Phase II HERTHENA-Lung01 trial of patritumab deruxtecan for patients with locally advanced or metastatic EGFR mutation-positive NSCLC who have received prior treatment with osimertinib and at least 1 platinum-based chemotherapy regimen Design, eligibility criteria and key endpoints of the ongoing Phase III GEOMETRY-E trial of capmatinib in combination with osimertinib versus chemotherapy as second-line therapy for patients with locally advanced or metastatic NSCLC harboring non-T790M EGFR activating mutations as well as MET amplification after disease progression on a first/second EGFR tyrosine kinase inhibitor or osimertinib Mechanism of action of sotorasib and available efficacy and safety data from the Phase II CodeBreak 100 trial evaluating sotorasib in patients with previously treated KRAS G12C mutation-positive NSCLC; FDA priority review for sotorasib for KRAS G12C-mutated advanced NSCLC Other ongoing and planned clinical trials investigating novel agents and strategies for patients with advanced NSCLC harboring targetable gene alterations (eg, ECOG-ACRIN LUNG-MAP)
  • ||||||||||  [VIRTUAL] Research Advances Shaping the Current and Future Treatment of NSCLC with ALK and ROS1 Rearrangements () -  Jun 5, 2021 - Abstract #ASCO2021ASCO_5879;    
    Design, eligibility criteria and key findings from the Phase II VISION trial leading to the recent FDA approval of tepotinib for patients with metastatic NSCLC harboring MET exon 14 skipping alterations Rationale for the design of the ongoing Phase II NAUTIKA1 neoadjuvant and adjuvant study of alectinib, entrectinib, vemurafenib/cobimetinib or pralsetinib for patients with resectable Stage II-III NSCLC harboring ALK, ROS1, NTRK, BRAF V600 or RET molecular alterations Key efficacy and safety outcomes from the Phase II GEOMETRY mono-1 trial supporting the FDA approval of capmatinib for patients with MET exon 14 mutation-positive metastatic NSCLC Practical integration and optimal sequencing of capmatinib and tepotinib into current clinical management of patients with advanced NSCLC harboring MET exon 14 skipping alterations Available safety and efficacy results from the LIBRETTO-001 and ARROW trials leading to the FDA approvals of selpercatinib and pralsetinib for patients with RET fusion-driven NSCLC; optimal integration into clinical practice Design, eligibility and key endpoints of the Phase III LIBRETTO-431 and AcceleRET Lung studies assessing selpercatinib and pralsetinib, respectively, compared to first-line chemotherapy with or without pembrolizumab in patients with treatment-naïve RET fusion-positive advanced NSCLC Frequency and clinical impact of HER2 overexpression or mutations in NSCLC; key efficacy and safety findings from the Phase II DESTINY-Lung01 study evaluating trastuzumab deruxtecan in HER2-overexpressing or mutated NSCLC FDA breakthrough therapy designation and potential nonprotocol role of trastuzumab deruxtecan in patients with HER2-positive metastatic NSCLC Clinical impact of HER3 upregulation as a mechanism of resistance to EGFR tyrosine kinase inhibitors; early efficacy and safety findings with patritumab deruxtecan in a Phase I trial for previously treated patients with EGFR mutation-positive unresectable or metastatic NSCLC Ongoing Phase II HERTHENA-Lung01 trial of patritumab deruxtecan for patients with locally advanced or metastatic EGFR mutation-positive NSCLC who have received prior treatment with osimertinib and at least 1 platinum-based chemotherapy regimen Design, eligibility criteria and key endpoints of the ongoing Phase III GEOMETRY-E trial of capmatinib in combination with osimertinib versus chemotherapy as second-line therapy for patients with locally advanced or metastatic NSCLC harboring non-T790M EGFR activating mutations as well as MET amplification after disease progression on a first/second EGFR tyrosine kinase inhibitor or osimertinib Mechanism of action of sotorasib and available efficacy and safety data from the Phase II CodeBreak 100 trial evaluating sotorasib in patients with previously treated KRAS G12C mutation-positive NSCLC; FDA priority review for sotorasib for KRAS G12C-mutated advanced NSCLC Other ongoing and planned clinical trials investigating novel agents and strategies for patients with advanced NSCLC harboring targetable gene alterations (eg, ECOG-ACRIN LUNG-MAP) Current role of circulating DNA (ctDNA) sequencing, next-generation sequencing, fluorescence in situ hybridization (FISH) and immunohistochemistry testing platforms in the detection of actionable driver mutations and prediction of response to treatment Design, entry criteria and key efficacy and safety findings from the Phase III CROWN trial leading to the recent FDA approval of lorlatinib as first-line therapy for patients with ALK-positive advanced NSCLC; integration into current clinical management Similarities and differences in the efficacy and safety outcomes with first-line alectinib, brigatinib, ceritinib and lorlatinib for patients with metastatic NSCLC with an ALK rearrangement; optimal upfront regimen Assessment, frequency and spectrum of resistance mutations documented in patients with disease progression on an ALK inhibitor in the first-line setting; role of repeat testing and implications for subsequent therapeutic decision-making Pooled efficacy and safety findings supporting the FDA approval of entrectinib in ROS1- positive metastatic NSCLC; intracranial response rates in patients with CNS involvement Optimal approach to the management of adverse events (eg, cardiac, CNS and ocular toxicities) associated with entrectinib Current approach to therapeutic sequencing of available agents and regimens for patients with ALK- or ROS1-positive NSCLC Mechanism of action of repotrectinib and preliminary results from the cohort of patients with advanced NSCLC in the ongoing Phase I/II TRIDENT-1 trial evaluating repotrectinib for patients with advanced solid tumors harboring ALK, ROS1 or NTRK rearrangements; potential clinical role Comparison of the mechanisms of action of repotrectinib and other approved or promising investigational tyrosine kinase inhibitors targeting ALK and/or ROS1 in the management of NSCLC Rationale for the ongoing Phase I/II trial of ceritinib in combination with trametinib for patients with advanced ALK-positive NSCLC Ongoing and planned clinical trials investigating novel strategies (eg, ALBATROS) for patients with advanced NSCLC harboring ALK rearrangements or ROS1 fusions after the failure of first-line tyrosine kinase inhibitor
  • ||||||||||  Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
    [VIRTUAL] TARGETING ANAPLASTIC LYMPHOMA KINASE IN CONSENSUS MOLECULAR SUBTYPE 1 COLON CANCER PATIENTS () -  May 30, 2021 - Abstract #EACR2021EACR_2567;    
    An ALK signature of 65 genes statistically associated to worse relapse-free survival in CMS1 subtype. Conclusion These findings support the hypothesis that ALK may represent an attractive target for CRC therapy, and CMSs classification may provide a useful tool to identify patients who could benefit from ALK inhibition.
  • ||||||||||  Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
    [VIRTUAL] TARGETING ANAPLASTIC LYMPHOMA KINASE IN CONSENSUS MOLECULAR SUBTYPE 1 COLON CANCER PATIENTS () -  May 30, 2021 - Abstract #EACR2021EACR_2566;    
    An ALK signature of 65 genes statistically associated to worse relapse-free survival in CMS1 subtype. Conclusion These findings support the hypothesis that ALK may represent an attractive target for CRC therapy, and CMSs classification may provide a useful tool to identify patients who could benefit from ALK inhibition.
  • ||||||||||  Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
    [VIRTUAL] TARGETING ANAPLASTIC LYMPHOMA KINASE IN CONSENSUS MOLECULAR SUBTYPE 1 COLON CANCER PATIENTS () -  May 30, 2021 - Abstract #EACR2021EACR_2565;    
    An ALK signature of 65 genes statistically associated to worse relapse-free survival in CMS1 subtype. Conclusion These findings support the hypothesis that ALK may represent an attractive target for CRC therapy, and CMSs classification may provide a useful tool to identify patients who could benefit from ALK inhibition.
  • ||||||||||  Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
    [VIRTUAL] TARGETING ANAPLASTIC LYMPHOMA KINASE IN CONSENSUS MOLECULAR SUBTYPE 1 COLON CANCER PATIENTS () -  May 30, 2021 - Abstract #EACR2021EACR_2564;    
    An ALK signature of 65 genes statistically associated to worse relapse-free survival in CMS1 subtype. Conclusion These findings support the hypothesis that ALK may represent an attractive target for CRC therapy, and CMSs classification may provide a useful tool to identify patients who could benefit from ALK inhibition.
  • ||||||||||  Xalkori (crizotinib) / Pfizer, Alecensa (alectinib) / Roche
    Clinical, Journal:  Impact of ALK Inhibitors in Patients With ALK-Rearranged Nonlung Solid Tumors. (Pubmed Central) -  May 27, 2021   
    Conclusion These findings support the hypothesis that ALK may represent an attractive target for CRC therapy, and CMSs classification may provide a useful tool to identify patients who could benefit from ALK inhibition. This study highlights the potential benefit of ALK-TKIs, especially alectinib, in patients with ALK-rearranged nonlung solid tumors.
  • ||||||||||  Alecensa (alectinib) / Roche
    Journal:  A cascade dual-targeted nanocarrier for enhanced alectinib delivery to ALK-positive lung cancer. (Pubmed Central) -  May 15, 2021   
    As a result, this dual-targeted polymeric nanocarrier exhibited superior therapeutic effects and induced tumor shrinkage in vivo. Meanwhile, this dual-targeted nanocarrier also minimized alectinib-induced hepatotoxicity, providing an efficient strategy to extend the application of alectinib for NSCLC patients.