patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Merck (MSD) 
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  • ||||||||||  [VIRTUAL] Optimal Therapeutic Approaches for Patients with Genomic Aberrations beyond EGFR, ALK and ROS1 () -  Jun 5, 2021 - Abstract #ASCO2021ASCO_5880;    
    Not yet recruiting --> Recruiting 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)
  • ||||||||||  fulvestrant / Generic mfg.
    [VIRTUAL] Module 2: Selection and Sequencing of Therapy for ER-Positive, HER2-Negative Metastatic Breast Cancer (mBC) () -  Jun 5, 2021 - Abstract #ASCO2021ASCO_5852;    
    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) Long-term follow-up data with a CDK4/6 inhibitor — palbociclib, ribociclib or abemaciclib — and an endocrine partner for patients with ER-positive mBC; factors in the selection of an agent Proposed mechanisms of resistance to CDK4/6 inhibition; incidence, identification and prognostic significance of PIK3CA mutations in patients with ER-positive mBC Published research findings with alpelisib/fulvestrant for patients with ER-positive mBC with a PIK3CA mutation; Phase II BYLieve study affirming the utility of this combination after disease progression on a CDK4/6 inhibitor Spectrum, frequency and severity of alpelisib-related toxicities; optimal prevention and management strategies Other novel agents and strategies under investigation for ER-positive mBC (eg, capivasertib, venetoclax, patritumab deruxtecan)
  • ||||||||||  patritumab deruxtecan (U3-1402) / Daiichi Sankyo, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
    Review, Journal:  HER2-/HER3-Targeting Antibody-Drug Conjugates for Treating Lung and Colorectal Cancers Resistant to EGFR Inhibitors. (Pubmed Central) -  Apr 7, 2021   
    Furthermore, HER3-targeting patritumab deruxtecan, another ADC, exhibited impressive tumor shrinkage in pretreated patients with EGFR-mutated NSCLC, in a phase 1 clinical trial. This manuscript presents an overview of the accumulated evidence on HER2- and HER3-targeting therapy, especially ADCs, and discussion of remaining issues for further improving these treatments in cancers resistant to EGFR inhibitors.