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  • ||||||||||  Yondelis (trabectedin) / Otsuka, PharmaMar, Valeo Pharma, J&J, Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Review, Journal, Tumor microenvironment:  Trabectedin and Lurbinectedin Modulate the Interplay between Cells in the Tumour Microenvironment-Progresses in Their Use in Combined Cancer Therapy. (Pubmed Central) -  Jan 27, 2024   
    Finally, the novel therapeutic venues that are currently under exploration, in combination with a plethora of different immunotherapeutic strategies or specific molecular-targeted inhibitors, are reviewed, with particular emphasis on the usage of immune checkpoint inhibitors, or other bioactive molecules that have shown synergistic effects in terms of tumour regression and ablation. These approaches intend to tackle the complexity of managing cancer patients in the context of precision medicine and the application of tailor-made strategies aiming at the reduction of undesired side effects.
  • ||||||||||  Pozenveo (poziotinib) / Assertio
    Trial completion date, Trial termination, EGFR exon 20, HER2 exon 20, Metastases:  ZENITH20: Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation (clinicaltrials.gov) -  Jan 25, 2024   
    P2,  N=648, Terminated, 
    These approaches intend to tackle the complexity of managing cancer patients in the context of precision medicine and the application of tailor-made strategies aiming at the reduction of undesired side effects. Trial completion date: Dec 2023 --> Apr 2023 | Active, not recruiting --> Terminated; Strategic business decision (unrelated to safety)
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Review, Journal, Real-world evidence, Real-world:  Review of real-world experience with lurbinectedin in relapsed/refractory small cell lung cancer. (Pubmed Central) -  Jan 18, 2024   
    Since then, real-world studies have examined the efficacy and safety profiles of lurbinectedin in clinical practice. By examining these outcomes, this review aims to provide clinicians with the tools necessary to make informed clinical decisions.
  • ||||||||||  Journal, EGFR exon 20:  The Impact of On-Target Resistance Mediated by EGFR-T790M or EGFR-C797S on EGFR Exon 20 Insertion Mutation Active Tyrosine Kinase Inhibitors. (Pubmed Central) -  Jan 17, 2024   
    This report highlights that poziotinib and mobocertinib are susceptible to on-target resistance mediated by EGFR-T790M or -C797S in the background of the most prevalent EGFR exon 20 insertion mutations. Furmonertinib, sunvozertinib, and to a less extent zipalertinib can overcome EGFR-T790M compound mutants, whereas EGFR-C797S leads to covalent inhibitor cross-resistance-robust data that support the limitations of mobocertinib and should further spawn the development of next-generation covalent and reversible EGFR exon 20 insertion mutation active inhibitors with favorable therapeutic windows that are less vulnerable to on-target resistance.
  • ||||||||||  Imdelltra (tarlatamab) / Amgen
    Trial primary completion date:  DeLLphi-304: Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer (clinicaltrials.gov) -  Jan 3, 2024   
    P3,  N=700, Recruiting, 
    Furmonertinib, sunvozertinib, and to a less extent zipalertinib can overcome EGFR-T790M compound mutants, whereas EGFR-C797S leads to covalent inhibitor cross-resistance-robust data that support the limitations of mobocertinib and should further spawn the development of next-generation covalent and reversible EGFR exon 20 insertion mutation active inhibitors with favorable therapeutic windows that are less vulnerable to on-target resistance. Trial primary completion date: Nov 2024 --> Sep 2025
  • ||||||||||  Pozenveo (poziotinib) / Spectrum Pharma, Luye Group, foretinib (GSK1363089) / Exelixis, pexmetinib (ARRY-614) / Pfizer
    Preclinical, Journal, IO biomarker:  Screening of potent RIPK3 inhibitors to attenuate necroptosis and inflammation in mouse traumatic brain injury models. (Pubmed Central) -  Jan 3, 2024   
    In our study, we explored the role of NBCs in neuroprotection after traumatic brain injury. It's effectiveness in traumatic brain injury animal models and favorable safety profiles make it a potential candidate for the advances of new therapies for necroptosis-associated neuroinflammatory disorders.
  • ||||||||||  Enrollment open, Metastases:  ORIENTA: Organoid-based Functional Precision Therapy for Advanced Breast Cancer (clinicaltrials.gov) -  Dec 29, 2023   
    P2,  N=252, Recruiting, 
    It's effectiveness in traumatic brain injury animal models and favorable safety profiles make it a potential candidate for the advances of new therapies for necroptosis-associated neuroinflammatory disorders. Not yet recruiting --> Recruiting
  • ||||||||||  Journal:  In brief: Three new injectable antipsychotic drugs. (Pubmed Central) -  Dec 26, 2023   
    Exposure differences were mainly attributed to body weight, while dose adjustments were not needed for patients of different racial identities. No abstract available
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Trial completion date, Trial primary completion date:  Lurbinectedin With Berzosertib, an ATR Kinase Inhibitor in Small Cell Cancers and High-Grade Neuroendocrine Cancers (clinicaltrials.gov) -  Dec 15, 2023   
    P1/2,  N=75, Recruiting, 
    These results indicated that RBEM could induce toxicity in female rats and exert effect on fertility and early embryonic development stage. Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Aug 2025 --> Aug 2026
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Lurbinectedin in prostatic small cell and neuroendocrine carcinoma. (Level 1, West Hall; Poster Bd # G14) -  Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_349;    
    L is a well-tolerated and active treatment option for patients with SC/NEPC. Prospective studies are needed to determine the role of L in the treatment of SC/NEPC.
  • ||||||||||  Olita (olmutinib) / Hanmi, Pozenveo (poziotinib) / Spectrum Pharma, Luye Group
    Preclinical, Journal, IO biomarker:  In Silico and In Vitro Exploration of Poziotinib and Olmutinib Synergy in Lung Cancer: Role of hsa-miR-7-5p in Regulating Apoptotic Pathway Marker Genes. (Pubmed Central) -  Nov 29, 2023   
    Molecular docking indicated strong binding of poziotinib and olmutinib to extrinsic and intrinsic apoptotic pathway markers, with binding energies of -9.4 kcal/mol and -8.5 kcal/mol, respectively, on interacting with STK-11. Combining poziotinib and olmutinib therapies may significantly improve drug tolerance and conquer drug resistance more effectively than using them individually in lung cancer patients, as suggested by this study's mechanisms.
  • ||||||||||  5-fluorouracil / Generic mfg., Zepzelca (lurbinectedin) / PharmaMar, Jazz, irinotecan / Generic mfg.
    Preclinical, Journal, Combination therapy:  Preclinical Synergistic Combination Therapy of Lurbinectedin with Irinotecan and 5-Fluorouracil in Pancreatic Cancer. (Pubmed Central) -  Nov 28, 2023   
    We further demonstrate that the triple combination between lurbinectedin, irinotecan, and 5-fluorouracil (5-FU) results in a highly efficient killing of tumor cells. Our results are developing insights regarding molecular mechanisms underlying the therapeutic efficacy of a novel combination drug treatment for pancreatic cancer.
  • ||||||||||  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.
  • ||||||||||  Avastin (bevacizumab) / Roche, Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Enrollment open, Phase classification, Combination therapy:  Phase 1b of Lurbinectedin in Combination With Weekly Paclitaxel and Bevacizumab in Platinum-resistant Ovarian Cancer (clinicaltrials.gov) -  Nov 18, 2023   
    P1,  N=34, Recruiting, 
    However, outcomes for relapsed SCLC remain suboptimal, particularly for patients with a shorter chemotherapy-free interval and central nervous system metastases. Not yet recruiting --> Recruiting | Phase classification: P1b --> P1
  • ||||||||||  utidelone IV (UTD1) / Beijing Biostar Technologies
    Trial completion date, Trial primary completion date, Monotherapy, Metastases:  Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) -  Nov 8, 2023   
    P2,  N=120, Recruiting, 
    Phase classification: P1 --> P1/2 | N=25 --> 184 Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Aug 2023 --> Mar 2024
  • ||||||||||  utidelone IV (UTD1) / Beijing Biostar Technologies
    Enrollment open, Trial initiation date, Metastases:  Utidelone Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) -  Nov 8, 2023   
    P3,  N=612, Recruiting, 
    Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Aug 2023 --> Mar 2024 Not yet recruiting --> Recruiting | Initiation date: Jan 2023 --> May 2023
  • ||||||||||  Pozenveo (poziotinib) / Spectrum Pharma, Luye Group, Nerlynx (neratinib) / Puma, Knight Therap, Pierre Fabre
    Journal:  The uncharted role of HER2 mutant alleles in breast cancer. (Pubmed Central) -  Nov 5, 2023   
    Herein, we discuss the under-explored effects of individual HER2 mutant alleles on therapeutic response, a role for HER2 mutation in metastatic propensity, and differences in patient outcomes in ER+ invasive lobular carcinoma (ILC) versus invasive ductal carcinoma (IDC). The preclinical efficacy of additional agents is also discussed, particularly the pan-HER inhibitor poziotinib.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Trial completion date, Trial primary completion date:  Lurbinectedin + Doxorubicin In Leiomyosarcoma (clinicaltrials.gov) -  Oct 31, 2023   
    P1b/2,  N=62, Recruiting, 
    The preclinical efficacy of additional agents is also discussed, particularly the pan-HER inhibitor poziotinib. Trial completion date: Jan 2025 --> Jul 2025 | Trial primary completion date: Jan 2024 --> Jul 2024
  • ||||||||||  Imdelltra (tarlatamab) / Amgen
    Trial completion date, Trial primary completion date:  DeLLphi-304: Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer (clinicaltrials.gov) -  Sep 28, 2023   
    P3,  N=700, Recruiting, 
    Moreover, 120h continuous intravenous infusion is a more tolerable administration method than 5 days intermittent infusion, worthy further study. Trial completion date: May 2028 --> Sep 2027 | Trial primary completion date: Jul 2025 --> Nov 2024
  • ||||||||||  LYB001 / Luye Group
    Trial completion date, Trial termination:  Efficacy and Safety of COVID-19 Vaccine as Booster Vaccination in Adults 18 Years of Age or Older (clinicaltrials.gov) -  Sep 26, 2023   
    P3,  N=3000, Terminated, 
    Trial completion date: May 2028 --> Sep 2027 | Trial primary completion date: Jul 2025 --> Nov 2024 Trial completion date: Jan 2024 --> Jun 2023 | Active, not recruiting --> Terminated; According to the development of the novel coronavirus epidemic situation and the company's R&D decision
  • ||||||||||  LYB001 / Luye Group
    Enrollment change, Trial completion date, Trial initiation date, Trial withdrawal, Trial primary completion date:  Immunogenicity and Safety of COVID-19 Vaccine in Population Aged 18 Years and Above (clinicaltrials.gov) -  Sep 26, 2023   
    P2,  N=0, Withdrawn, 
    Trial completion date: Jan 2024 --> Jun 2023 | Active, not recruiting --> Terminated; According to the development of the novel coronavirus epidemic situation and the company's R&D decision N=720 --> 0 | Trial completion date: Jun 2024 --> Jun 2023 | Initiation date: Jun 2023 --> Jan 2023 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2023 --> Jun 2023
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Journal, BRCA Biomarker, Metastases:  Pooled Safety Analysis of Single-Agent Lurbinectedin in Patients With Advanced Solid Tumours. (Pubmed Central) -  Sep 18, 2023   
    This analysis confirms a manageable safety profile for lurbinectedin in patients with advanced solid tumours. Findings are consistent with those reported in patients with relapsed SCLC, Ewing sarcoma, germline BRCA1/2 metastatic breast cancer, neuroendocrine tumours and ovarian cancer.
  • ||||||||||  Pozenveo (poziotinib) / Spectrum Pharma, Luye Group, Exkivity (mobocertinib) / Takeda, Nerlynx (neratinib) / Puma, Knight Therap, Pierre Fabre
    Journal:  Acquired secondary HER2 mutations enhance HER2/MAPK signaling and promote resistance to HER2 kinase inhibition in breast cancer. (Pubmed Central) -  Sep 18, 2023   
    HER2 mutations drive the growth of a subset of breast cancers and are targeted with HER2 tyrosine kinase inhibitors (TKI) such as neratinib...Cells expressing double HER2 mutations exhibited resistance to most HER2 TKIs but retained sensitivity to mobocertinib and poziotinib...Double-mutant cells showed enhanced MEK/ERK signaling, which was blocked by combined inhibition of HER2 and MEK. Together, these findings reveal the driver function of secondary HER2 mutations in resistance to HER2 inhibition and provide a potential treatment strategy to overcome acquired resistance to HER2 TKIs in HER2-mutant breast cancer.