Zepzelca (lurbinectedin) / PharmaMar, Jazz 
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 26 Diseases   31 Trials   31 Trials   1838 News 


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  • ||||||||||  [VIRTUAL] Marine pharmacology and the marine pharmaceuticals pipeline in 2020 () -  Dec 26, 2020 - Abstract #ASHP2020ASHP_1531;    
    The amount of FDA-approved marine-derived drugs continuously rise, showing the biodiversity and potential of the ocean's marine organisms. We thus conclude that as of September 2020, both the marine pharmacology preclinical and clinical pharmaceutical pipelines continued to remain very active.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    [VIRTUAL] Exposure-Response Analyses and Clinical Utility Index to Justify the Dosage of Lurbinectedin in Small-cell Lung Cancer (ePoster Hall) -  Dec 17, 2020 - Abstract #IASLCWCLC2020IASLC_WCLC_1135;    
    Conclusion The recommended lurbinectedin dosing regimen of 3.2 mg/m² q3wk provided maximum benefit in SCLC patients with disease progression on or after platinum-based chemotherapy with manageable probability of grade 4 neutropenia. Lowering the dose resulted in reduced efficacy, whereas increasing the dose led to an increased incidence of severe hematological toxicity without improvement of efficacy.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    [VIRTUAL] Semi-Mechanistic Models of the Time Course of Neutrophils and Platelets in Cancer Patients Treated With Lurbinectedin (ePoster Hall) -  Dec 17, 2020 - Abstract #IASLCWCLC2020IASLC_WCLC_1134;    
    Apart from body surface area and baseline platelets ≥250×109/L, other covariates did not have any clinically relevant effects on model pharmacokinetic/pharmacodynamic parameters and, therefore, dosage adjustments based on these covariates are not warranted. Conclusion In cancer patients administered lurbinectedin, any neutropenia and thrombocytopenia observed were non-cumulative, reversible, short lasting, and clinically manageable with secondary prophylaxis with G-CSF or platelet transfusions and, depending on severity, dose reduction or discontinuation of lurbinectedin.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Zepzelca (lurbinectedin) / PharmaMar, Jazz
    [VIRTUAL] Lurbinectedin in Combination with Pembrolizumab for Patients with Relapsed Small Cell Lung Cancer. LUPER Clinical Trial (ePoster Hall) -  Dec 17, 2020 - Abstract #IASLCWCLC2020IASLC_WCLC_1116;    
    P1/2
    Secondary objectives include: (i) to obtain preliminary information on clinical antitumor activity of this combination in pts with SCLC, (ii) to characterize antitumor activity of this combination as per RECIST 1.1 in terms of overall response rate (ORR), duration of response (DOR), progression-free survival (PFS) and overall survival (OS), (iii) to characterize the safety profile and the plasma pharmacokinetics (PK) of the combination, (iv) to perform pharmacogenetic (PGt) and pharmacogenomic (PGx) analysis in tumor samples of pts. Current status active, not yet recruiting.
  • ||||||||||  paclitaxel / Generic mfg., doxorubicin hydrochloride / Generic mfg.
    Review, Journal, PARP Biomarker, IO Biomarker:  Drugs in development for small cell lung cancer. (Pubmed Central) -  Nov 21, 2020   
    Aurora A kinase (AAK) inhibitors showed initial activity when given with paclitaxel but in randomized studies, failed to improve outcomes over paclitaxel plus placebo...Delta-like protein 3 (DLL3) is an appealing therapeutic target given its selective expression on SCLC cells, but after initial exciting results, the antibody-drug conjugate (ADC) Rovalpituzumab tesirine (Rova-T) did not have a favorable efficacy to toxicity profile in randomized trials...Targeting angiogenesis has yielded modest improvements in the past but newer agents such as anlotinib are renewing interest. While the current therapeutic landscape beyond chemo-immunotherapy remains the same as it was decades ago, drug development for SCLC is rapidly moving forward and promises to deliver the needed novel agents in the very near future.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Clinical, Clinical guideline, Journal, IO Biomarker:  SEOM clinical guidelines for the treatment of small-cell lung cancer (SCLC) (2019). (Pubmed Central) -  Nov 2, 2020   
    Reinduction with platinum-etoposide is the recommended regimen in patients with sensitive relapse (≥ 3 months) and new drugs such as lurbinectedin and immunotherapy are new treatment options. New biomarkers and new clinical trials designed according to the new classification of SCLC subtypes defined by distinct gene expression profiles are necessary.
  • ||||||||||  Yondelis (trabectedin) / Otsuka, PharmaMar, Valeo Pharma, Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Journal, PD(L)-1 Biomarker, IO Biomarker:  Specific Effects of Trabectedin and Lurbinectedin on Human Macrophage Function and Fate-Novel Insights. (Pubmed Central) -  Oct 26, 2020   
    New biomarkers and new clinical trials designed according to the new classification of SCLC subtypes defined by distinct gene expression profiles are necessary. The results provide evidence of additional onco-therapeutic actions for these drugs.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Enrollment open, Trial initiation date, PD(L)-1 Biomarker:  LUPER: Lurbinectedin (PM01183) Combined With Pembrolizumab in Small Cell Lung Cancer. (clinicaltrials.gov) -  Oct 19, 2020   
    P1/2,  N=42, Recruiting, 
    The results provide evidence of additional onco-therapeutic actions for these drugs. Not yet recruiting --> Recruiting | Initiation date: May 2020 --> Sep 2020
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    [VIRTUAL] Activity of Lurbinectedin in Second-line SCLC Patients Who Are Candidates for Platinum Rechallenge () -  Sep 29, 2020 - Abstract #IASLCNACLC2020IASLC-NACLC_121;    
    Lurbinectedin appears to be an effective treatment for patients with platinum-sensitive relapsed SCLC with CTFI ≥90 days and CTFI ≥180 days (post hoc analysis), with acceptable safety and tolerability. These results suggest lurbinectedin may represent a valuable alternative to platinum rechallenge.