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  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Efficacy and safety of lurbinectedin in elderly patients with relapsed SCLC. (On Demand | Hall A; Poster Bd # 218) -  Apr 26, 2023 - Abstract #ASCO2023ASCO_1977;    
    P2, P3
    Clinical trial information: NCT02454972, NCT02566993. >* Growth colony-stimulating factors were mandatory for both ATLANTIS treatment arms.** Nominal comparisons in ATLANTIS (small number of patients in basket trial)AEs, adverse events; CI, confidence interval; mo, months; OS, overall survival.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Enrollment open, Trial completion date, Trial primary completion date, Metastases:  Safety Tolerability Pharmacokinetic and Preliminary Efficacy in Chinese Advanced Solid Tumors Patients (clinicaltrials.gov) -  Apr 26, 2023   
    P1,  N=28, Recruiting, 
    Lurbinectedin provides an additional option from second-line for ES-SCLC, with efficacy outcomes comparable to that of historical treatments. Not yet recruiting --> Recruiting | Trial completion date: Aug 2022 --> Dec 2024 | Trial primary completion date: Feb 2022 --> Dec 2024
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    #Lurbinectedin (Twitter) -  Apr 16, 2023   
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    ¿Lurbinectedin? (Twitter) -  Mar 30, 2023   
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Checkpoint inhibition:  Immune Checkpoint Inhibition With Lurbinectedin Relapsed/Recurrent SCLC (clinicaltrials.gov) -  Mar 27, 2023   
    P1/2,  N=9, Terminated, 
    Hence we expect BR101801 would become a promising therapeutic option for R/R PTCL patients. N=57 --> 9 | Trial completion date: Oct 2025 --> Mar 2023 | Recruiting --> Terminated | Trial primary completion date: Oct 2024 --> Mar 2023; DLTs
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Review, Journal, PD(L)-1 Biomarker, IO biomarker:  Emerging Strategies for the Treatment of Small Cell Lung Cancer: A Review. (Pubmed Central) -  Mar 21, 2023   
    For second-line treatment, a novel alkylating agent, lurbinectedin, which inhibits oncogenic transcription, has been approved for use in patients with metastatic SCLC...Advances in research have revealed critical information regarding biologic characteristics of the disease, which may lead to the identification of vulnerabilities and the development of new therapies. Further research focused on identifying biomarkers and evaluating innovative therapies will be paramount to improving treatment outcomes for patients with SCLC.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Lurbinectedin shows potent activity in all four molecular subtypes of small cell lung cancer (SCLC) and POU2F3 and SLFN11 are biomarkers for a better response (Section 19; Poster Board #17) -  Mar 14, 2023 - Abstract #AACR2023AACR_8450;    
    P2
    Trial completion date: Jun 2024 --> Jan 2026 | Trial primary completion date: Jun 2024 --> Oct 2025 The aim of this study was to analyze the activity of lurbinectedin in the different SCLC molecular subtypes and to investigate new biomarkers of response.Methods and Results - We have characterized a panel of 20 SCLC human cell lines based on the expression of ASCL1, NEUROD1, YAP1 and POU2F3, where lurbinectedin yielded a mean IC50 value of 6.52 nM, which is considerable greater than the activity exerted by topotecan, irinotecan, carboplatin, etoposide, olaparib, alisertib and navitoclax (IC50 100
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Lurbinectedin exhibits combinatorial activity with BCL2/BCL2L1 inhibitors in vitro and in vivo by modulation of MCL1 expression (Section 16; Poster Board #17) -  Mar 14, 2023 - Abstract #AACR2023AACR_8393;    
    Correspondingly in vivo, enhancement in the efficacy of lurbinectedin was observed in combination with venetoclax in SCLC models, while in solid tumor models other than SCLC the combination with a specific BCL2L1 inhibitor enhanced efficacy. Collectively, these data identify MCL1 as a specific lurbinectedin target and suggest that combinations that target other pro-survival proteins may represent a viable strategy to enhance the anti-tumor activity of lurbinectedin.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Exportin 1 inhibition synergizes with lurbinectedin by altering the response to DNA damage in neuroendocrine lung tumors (Section 17; Poster Board #17) -  Mar 14, 2023 - Abstract #AACR2023AACR_8340;    
    These data indicates that inhibition of exportin 1 with selinexor in combination with lurbinectedin is a promising therapeutic strategy in lung NECs. Subsequent In vivo testing in patient-derived xenograft to study efficacy and toxicity of this combination will provide preclinical rationale for clinically exploring this combination in patients with lung NECs who have failed chemotherapy regimen.
  • ||||||||||  ONC212 / Chimerix, Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Synergistic combinations of lurbinectedin with irinotecan and ONC212 in pancreatic cancer (Section 14; Poster Board #10) -  Mar 14, 2023 - Abstract #AACR2023AACR_4896;    
    This is being explored by co-culturing CD8+ T lymphoblast cells with pancreatic tumor cells treated with lurbinectedin, irinotecan, ONC212, and combination, along with molecular mechanisms of cell death and effects on cytokines in the tumor microenvironment. Our results are developing insights regarding molecular mechanisms underlying therapeutic efficacy of a novel combination drug treatment for pancreatic cancer.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    High SLFN11 expression correlates with sensitivity to lurbinectedin in small cell lung cancer (SCLC) models (Section 39; Poster Board #19) -  Mar 14, 2023 - Abstract #AACR2023AACR_3442;    
    The in vivo efficacy data confirms that the SLFN11 high NCI-H1048 model is more responsive with 90% TGI compared to 35% observed in SLFN11 low models (NCI-H889 and NCI-H69) at the highest lurbinectedin dose (p-value = 0.006). Efficacy data confirms correlation to SLFN11 protein expression, consistent with the RNA level association.
  • ||||||||||  Bavencio (avelumab) / EMD Serono, Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Trial initiation date, Metastases:  Phase II Trial of Lurbinectedin Combined With Avelumab as Switch Maintenance Firstline Therapy (clinicaltrials.gov) -  Mar 14, 2023   
    P2,  N=36, Not yet recruiting, 
    Efficacy data confirms correlation to SLFN11 protein expression, consistent with the RNA level association. Initiation date: Jan 2023 --> May 2023
  • ||||||||||  Aplidin (plitidepsin) / PharmaMar, Roche
    Trial termination:  Neptuno: Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection (clinicaltrials.gov) -  Mar 9, 2023   
    P3,  N=205, Terminated, 
    Our data strongly suggest that c-Myc/Bcl-2/Mcl-1 triple targeting through a combination of BR101801 and Venetoclax could be a potential clinical option for double-hit DLBCL. Active, not recruiting --> Terminated; Sponsor has decided to end the study prematurely based on significant difficulties in the recruitment of patients, despite the implementation of corrective measures that still failed to increase the accrual rate required for a feasible completion.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Cost-Effectiveness Modeling of Lurbinectedin As a Second-Line Therapy in Patients with Small Cell Lung Cancer (SCLC) () -  Mar 9, 2023 - Abstract #ISPOR2023ISPOR_894;    
    Based on a published network meta-analysis, a subgroup analysis in platinum-sensitive patients (chemotherapy-free interval ?90 days) that compared lurbinectedin against platinum rechallenge (PR) and topotecan (intravenous [TOP-IV] and oral [TOP-oral]) was conducted. Lurbinectedin is a cost-effective second-line treatment for patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy and is under the willingness-to-pay thresholds of $100,000/QALY.
  • ||||||||||  SNB-101 / SN BioSci
    Trial completion date, Trial primary completion date, Metastases:  Dose-finding Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SNB-101(SN-38) in Patients With Tumors (clinicaltrials.gov) -  Mar 3, 2023   
    P1,  N=36, Recruiting, 
    Lurbinectedin is a cost-effective second-line treatment for patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy and is under the willingness-to-pay thresholds of $100,000/QALY. Trial completion date: Mar 2022 --> Dec 2023 | Trial primary completion date: Jan 2022 --> May 2023
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Enrollment closed, Enrollment change, Combination therapy:  LUPER: Lurbinectedin (PM01183) Combined With Pembrolizumab in Small Cell Lung Cancer. (clinicaltrials.gov) -  Mar 3, 2023   
    P1/2,  N=28, Active, not recruiting, 
    Trial completion date: Mar 2022 --> Dec 2023 | Trial primary completion date: Jan 2022 --> May 2023 Recruiting --> Active, not recruiting | N=42 --> 28
  • ||||||||||  Aplidin (plitidepsin) / PharmaMar, Roche
    Journal:  A Survey of Didemnin Depsipeptide Production in Tistrella. (Pubmed Central) -  Feb 24, 2023   
    Originally developed as anticancer therapeutics, the recent re-evaluation of these compounds including synthetically derived dehydrodidemnin B or Aplidine, has led to their advancement towards antiviral applications...To this end, we conducted a survey of known species of Tistrella and report on their ability to produce the didemnin depsipeptides. These data were used to develop conditions to produce didemnin B at titers over 15 mg/L.
  • ||||||||||  Aplidin (plitidepsin) / PharmaMar, Roche
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date:  Neptuno: Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection (clinicaltrials.gov) -  Feb 21, 2023   
    P3,  N=205, Active, not recruiting, 
    These data were used to develop conditions to produce didemnin B at titers over 15 mg/L. Recruiting --> Active, not recruiting | N=609 --> 205 | Trial completion date: Dec 2023 --> Mar 2023 | Trial primary completion date: Dec 2023 --> Mar 2023
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    CME/MOC Credit - Facilitating Progress in the Treatment of SCLC: How to Optimize the Use of Current Systemic Options and Accelerate the Clinical Transition of Investigational Approaches by PeerView (Starlight Ballroom) -  Feb 19, 2023 - Abstract #IASLCTTLC2023IASLC_TTLC_183;    
    Notable advances such as chemo-immunotherapy in the first-line setting and lurbinectedin in the second-line setting have now become guideline-recommended standards of care and propelled the treatment of SCLC forward...In this PeerView Live Candid Conversations & Clinical Consults symposium, leading experts will weave together the latest evidence on standard-of-care therapies and the evolving data on new/emerging approaches to provide a big-picture overview of the present and future management of SCLC and how to accelerate further progress in this challenging disease. These discussions will be framed with illustrative patient cases to highlight evidence-based strategies to improve care and outcomes in SCLC.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Journal:  Editorial: Small cell lung cancer: New drugs and strategies. (Pubmed Central) -  Feb 14, 2023   
    These discussions will be framed with illustrative patient cases to highlight evidence-based strategies to improve care and outcomes in SCLC. No abstract available