- |||||||||| Trodelvy (sacituzumab govitecan-hziy) / Gilead
Review, Journal: Trop2-Targeted Molecular Imaging in Solid Tumors: Current Advances and Future Outlook. (Pubmed Central) - Dec 2, 2024 Notably, the U.S. Food and Drug Administration (FDA) has approved sacituzumab govitecan (SG), a novel Trop2-targeted agent, for treating triple-negative breast cancer (TNBC) and refractory urothelial cancer, highlighting the significance of Trop2 in clinical oncology...We critically evaluate the current state by examining the relevant applications, diagnostic accuracy, therapeutic efficacy, and inherent limitations. Finally, we analyze the challenges impeding widespread clinical application and offer insights into strategies for advancing the field, thereby guiding future research endeavors.
- |||||||||| Trodelvy (sacituzumab govitecan-hziy) / Gilead, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date, Metastases: CA209-63Y: Combination of Ipi/Nivo Plus Sacituzumab Govitecan in Metastatic Cisplatin Ineligible Urothelial Carcinoma Patients (clinicaltrials.gov) - Dec 2, 2024 P1/2, N=46, Active, not recruiting, Finally, we analyze the challenges impeding widespread clinical application and offer insights into strategies for advancing the field, thereby guiding future research endeavors. Trial completion date: Oct 2025 --> Apr 2027 | Trial primary completion date: Oct 2024 --> Apr 2026
- |||||||||| Kadcyla (ado-trastuzumab emtansine) / Roche, Trodelvy (sacituzumab govitecan-hziy) / Gilead, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
Review, Journal: A Review of Current and Future Antibody Drug Conjugates in Breast Cancer. (Pubmed Central) - Nov 29, 2024 The future of this class of compounds is very exciting. This field is rapidly evolving with new ADCs being investigated and clinical trials looking at the use of known ADCs in earlier stage disease.
- |||||||||| imipenem/relebactam / Merck (MSD), Vabomere (meropenem/vaborbactam) / Melinta Therap, Menarini, Xerava (eravacycline) / SOM Biotech, Ewha Womans University, PAION, Innoviva
Journal, Gram negative: Colistin, Meropenem-Vaborbactam, Imipenem-Relebactam, and Eravacycline Testing in Carbapenem-Resistant Gram-Negative Rods: A Comparative Evaluation of Broth Microdilution, Gradient Test, and VITEK 2. (Pubmed Central) - Nov 27, 2024 VITEK 2 was mostly accurate in measuring ERV MICs, while the corresponding gradient test yielded reliable results exclusively in CREs. It is essential that laboratories are aware of which testing method provides reliable results for each combination of microorganisms and reserve antibiotics.
- |||||||||| Kadcyla (ado-trastuzumab emtansine) / Roche, Trodelvy (sacituzumab govitecan-hziy) / Gilead, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
Clinical data, Review, Journal: Unveiling the future of breast cancer therapy: Cutting-edge antibody-drug conjugate strategies and clinical outcomes. (Pubmed Central) - Nov 21, 2024 This review summarizes the efficacy and adverse effects of ADC therapies that have completed or are currently undergoing phase I-III clinical trials. Additionally, it analyzes potential combination strategies to overcome ADC resistance, aiming to provide clinicians with a comprehensive clinical guide to the use of ADCs in breast cancer treatment.
- |||||||||| zetomipzomib (KZR-616) / Kezar
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: A Study of Zetomipzomib (KZR-616) in Patients with Active Lupus Nephritis (PALIZADE) (clinicaltrials.gov) - Nov 19, 2024 P2, N=84, Terminated, Clinicians should be vigilant regarding unlisted ADEs when using sacituzumab govitecan, and close monitoring of laboratory indicators ensure patient medication safety. N=279 --> 84 | Trial completion date: Jul 2026 --> Nov 2024 | Suspended --> Terminated | Trial primary completion date: May 2026 --> Nov 2024; Sponsor Decision.
- |||||||||| Trodelvy (sacituzumab govitecan-hziy) / Gilead
Journal, BRCA Biomarker: Use of sacituzumab govitecan in frail patients with skin disease. (Pubmed Central) - Nov 18, 2024 The patient has no family history of breast cancer and does not have a mutation in the BRCA1/2 genes. In pathological history, only arterial hypertension under medical therapy with nebivolol.
- |||||||||| Trodelvy (sacituzumab govitecan-hziy) / Gilead
Journal: Activity of sacituzumab govitecan in skin metastases: description of a case. (Pubmed Central) - Nov 18, 2024 However, recent developments in molecular research and targeted therapy are opening up new perspectives with encouraging results for the treatment of this aggressive disease. The shared case wants to be an example: we will discuss the story of a 54 years old woman with extensive metastatic localizations in the skin that has obtained an important clinical response to therapy with sacituzumab govitecan, a conjugate antibody approved for the treatment of adult patients with metastatic triple negative breast cancer.
- |||||||||| Trodelvy (sacituzumab govitecan-hziy) / Gilead
Journal: Dual immunostimulatory CD73 antibody-polymeric cytotoxic drug complex for triple negative breast cancer therapy. (Pubmed Central) - Nov 17, 2024 However, the current ADC, sacituzumab govitecan, fails to overcome the crucial role of adenosine in the suppressive immune microenvironment characteristic of this "cold tumor"...Thus, it kills tumor cells with cytotoxic drugs, comprehensively regulates immunosuppression, and restores a durable immune response. This study proposes an antibody-polymeric drug complex with immunomodulatory and immunoagonist roles, offering new insights into TNBC treatment.
- |||||||||| Zeposia (ozanimod) / BMS
Review, Journal: The discovery and development of the sphingosine 1-phosphate receptor modulator ozanimod in ulcerative colitis. (Pubmed Central) - Nov 16, 2024 In this review, the discovery and development of the first approved S1P modulator, ozanimod, is described in detail: from design of initial screens to discover unique binding agents, to extensive chemical modifications to improve pharmacokinetic and safety profiles, and through preclinical and clinical studies validating mechanism and establishing safety and efficacy. Ultimately, this review will not only inform the reader of the unique path to development of a clinical S1P modulator for UC, but will also highlight advances made and gaps remaining to individualize therapeutic approaches for inflammatory bowel disease.
- |||||||||| Xerava (eravacycline) / SOM Biotech, Ewha Womans University, PAION, Innoviva
Journal: Eradication of Pseudomonas aeruginosa Persister Cells by Eravacycline. (Pubmed Central) - Nov 16, 2024 The effects of eravacycline on persister control were further validated in vivo using a lung infection model in mice. Collectively, these results demonstrate the possibility to control persister cells of bacterial pathogens by targeting dormancy.
- |||||||||| Xerava (eravacycline) / SOM Biotech, Ewha Womans University, PAION, Innoviva
Journal, Combination therapy: Combination Therapy of Trimethoprim-Sulfamethoxazole (TMP-SMZ) and Eravacycline for Treating Elizabethkingia anophelis-Induced Pulmonary Infections: A Case Report. (Pubmed Central) - Nov 15, 2024 Additionally, this report provides a summary of high-risk factors for E. anophelis infection, clinical manifestations, and therapeutic options. Given the high degree of antimicrobial drug resistance of the organism and the fact that inappropriate empirical antimicrobial therapy constitutes a risk factor for mortality, our case serves as a valuable reference for similar cases, highlighting potential strategies for effective management.
- |||||||||| Trodelvy (sacituzumab govitecan-hziy) / Gilead
Clinical, Review, Journal: Sacituzumab Govitecan in Triple Negative Breast Cancer: A Systematic Review of Clinical Trials. (Pubmed Central) - Nov 15, 2024 The efficacy results showed a significantly greater clinical benefit with sacituzumab govitecan compared to standard chemotherapy in patients with triple-negative breast cancer. This drug will become a treatment of substantial impact in future treatment guidelines for this type of cancer.
- |||||||||| Trodelvy (sacituzumab govitecan-hziy) / Gilead
Journal, IO biomarker: Genomic, immunologic, and prognostic associations of TROP2 (TACSTD2) expression in solid tumors. (Pubmed Central) - Nov 13, 2024 Overall, our results approved that ERV enhances the efficacy of anti-PD1 immunotherapy in melanoma by promoting the polarization of M1 macrophages, which provided novel therapeutic strategy for improving the effectiveness of melanoma anti-PD1 immunotherapy. TACSTD2 expression is associated with key driver alterations and a more active immune microenvironment, suggesting possible combinatorial strategies with TROP2-targeting ADCs plus immunotherapy in various solid tumors.
- |||||||||| Journal, PD(L)-1 Biomarker, IO biomarker, Metastases: Targeted and immunotherapy for the management of advanced urothelial carcinoma of the bladder. (Pubmed Central) - Nov 13, 2024
Pembrolizumab, with and without enfortumab, has demonstrated first-line activity, and avelumab is a key maintenance therapy after first-line treatment. The results of additional clinical trials should provide evidence to establish the exact role in therapy of each agent in patients with advanced disease.
- |||||||||| Emblaveo (aztreonam/avibactam) / Pfizer, AbbVie, Xerava (eravacycline) / SOM Biotech, Ewha Womans University, PAION, Innoviva
Clinical, Preclinical, Journal: In vitro activities of the essential antimicrobial agents including aztreonam/avibactam, eravacycline, colistin, and other comparators against carbapenem-resistant bacteria with different carbapenemase genes: a multicenter study in China, 2021. (Pubmed Central) - Nov 6, 2024 Using aztreonam/avibactam, eravacycline and colistin to treat infections caused by CRB offers significant advantages. These findings will guide clinical practice and optimize antimicrobial administration.
- |||||||||| Journal: Assessment of the activity and mechanisms of resistance to cefiderocol and combinations of ?-lactams and the novel ?-lactamase inhibitors avibactam, taniborbactam, zidebactam, nacubactam, xeruborbactam, and ANT3310 in emerging double-carbapenemase-producing Enterobacterales. (Pubmed Central) - Nov 6, 2024
Meropenem/ANT3310 (MIC50/MIC90 = 0.5/?64 mg/L; 47/57 susceptible) and cefepime/taniborbactam (MIC50/MIC90 = 0.5/16 mg/L; 44/57 susceptible) also retained high levels of activity, although they were affected by NDM-type enzymes in combination with porin deficiency. Our findings highlight that cefiderocol and combinations of ?-lactams and the novel ?-lactamase inhibitors avibactam, nacubactam, taniborbactam, zidebactam, xeruborbactam, and ANT3310 show promising activity against double-carbapenemase-producing Enterobacterales.
- |||||||||| Trodelvy (sacituzumab govitecan-hziy) / Gilead, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
Analysis of the Clinical Impact of the Time to Reimbursement of New Oncology Drugs in Spain: A Case Study in Breast Cancer () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_2342; Two molecules were analysed: trastuzumab-deruxtecan in unresectable/metastatic HER2+ and HER2-low breast cancer (BC); and sacituzumab-govitecan in unresectable/metastatic triple-negative BC (mTNBC). These results provide possible metrics to quantify the benefits that can be obtained if time to availability of medicines for patients is cut short through planned public policies.
- |||||||||| Trodelvy (sacituzumab govitecan-hziy) / Gilead, Talzenna (talazoparib) / Pfizer, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
Comparative Analysis of HTA Decisions for Metastatic Breast Cancer Treatments in Nordic Countries () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_2129; These results provide possible metrics to quantify the benefits that can be obtained if time to availability of medicines for patients is cut short through planned public policies. Denmark exhibited more restrictive recommendations, with certain treatments like Trodelvy
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