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  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Journal:  Accelerated approval requirements for lurbinectedin. (Pubmed Central) -  May 7, 2022   
    Active doses (40, 80, 120, and 160 mg per day) of ansofaxine in a controlled setting were safe, tolerated, and effective in improving depression symptoms in MDD patients. No abstract available
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Clinical, Journal:  Integrated exposure-response analysis of efficacy and safety of lurbinectedin to support the dose regimen in small-cell lung cancer. (Pubmed Central) -  May 6, 2022   
    P2
    From the perspective of the Chinese healthcare system, first-line LY01008 at a real-world dosage combined with chemotherapy is likely to represent a cost-effective strategy compared with first-line chemotherapy alone for Chinese advanced or recurrent nonsquamous NSCLC patients. The relationships evidenced in this integrated E-R analysis support a favorable benefit-risk profile for lurbinectedin 3.2 mg/m q3wk.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Journal:  Lurbinectedin-induced thrombocytopenia: the role of body surface area. (Pubmed Central) -  May 4, 2022   
    This recommendation was based on an exposure-response study, which demonstrated that patients with lower BSA had a higher incidence of thrombocytopenia. Herein we present the factors associated with BSA and thrombopoiesis, which may have contributed to the observed relationship.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Review, Journal:  Treatment of Small Cell Lung Cancer with Lurbinectedin: A Review. (Pubmed Central) -  Apr 29, 2022   
    Lurbinectedin is known to act by inhibiting the active transcription of encoding genes, thereby bringing about the suppression of tumour related macrophages with an impact on tumour atmosphere. Lurbinectedin has emerged as a potential drug candidate for the treatment of small cell lung cancer (SCLC).
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Analysis of patients with relapsed small cell lung cancer (SCLC) receiving single-agent lurbinectedin in the phase 3 ATLANTIS trial. (Available On Demand; 151) -  Apr 28, 2022 - Abstract #ASCO2022ASCO_5598;    
    P3
    The ATLANTIS trial (NCT02566993) investigated the combination of lurbinectedin 2.0 mg/m2 IV + doxorubicin (DOX) 40.0 mg/m2 IV versus topotecan or CAV. Patients with relapsed SCLC in ATLANTIS who completed 10 cycles of lurbinectedin + DOX combination and switched to lurbinectedin monotherapy tended to maintain or improve their tumor response (including an increase in CRs), with favorable OS and DOR and acceptable tolerability with no new safety signals.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    A phase 1b lead-in to a randomized phase 2 trial of lurbinectedin plus doxorubicin in leiomyosarcoma (LMS). (Available On Demand; 491a) -  Apr 28, 2022 - Abstract #ASCO2022ASCO_3164;    
    P1b/2
    Background: Single agent or combination chemotherapy regimens, typically including doxorubicin or gemcitabine, represent standard of care options for first- and second-line therapy in patients (pts) with metastatic LMS...Lurbinectedin is a novel structural analog of trabectedin with improved toxicity profile, potency, and pharmacokinetics...Regression analyses of survival data will be based on the Cox proportional hazards model. The first pt in dose-level 1 of the Phase 1b lead-in was enrolled in February 2022.
  • ||||||||||  Safety and efficacy of monoclonal antibodies and tyrosine kinase inhibitors in advanced breast carcinoma. () -  Apr 28, 2022 - Abstract #ASCO2022ASCO_1271;    
    Both monoclonal antibodies and tyrosine kinase inhibitors show clinically significant benefits in advanced HER2 positive breast carcinoma. However, more evidence and randomized clinical trials are needed to further establish their role in this rapidly evolving field.MAR = Margetuximab, TRA = Trastuzumab, ZENO = Zenocutuzumab, PER = Pertuzumab, SOC = Standard of Care, NER = Neratinib, CAP = Capecitabine, LAP = Lapatinib, TUC = Tucatinib, POZ = Poziotinib, PbO = Placebo, F.N = Febrile Neutropenia, D = Diarrhea, PPES = Palmar-Plantar Erythrodysesthesia, A = Anemia, N = Neutropenia.
  • ||||||||||  EPB-001 / Elpis Biopharma, Luye Group, EPIM-001 / Elpis Biopharma
    Enhancing Anti-Tumor Immune Response and Overcoming Resistance (Ballroom C) -  Apr 24, 2022 - Abstract #PEGS2022PEGS_499;    
    We will report the discovery and preclinical studies of EPIM-001, a bispecific IL2/PD-L1 biologics that has demonstrated multiple mechanisms of action and potent anti-tumor activity; EPB-001, a human anti-Siglec15 antibody that reversed immune suppression and inhibited tumor growth. EPIM-001 and EPB-001 could be promising therapeutics for tumors that are non-responding or resistant to immune checkpoint inhibitor treatment.