Luye Group 
Welcome,         Profile    Billing    Logout  
 36 Products   29 Diseases   36 Products   125 Trials   3206 News 


«12...1920212223242526272829...3637»
  • ||||||||||  Pozenveo (poziotinib) / Assertio
    Trial completion date, Trial primary completion date:  NCI-2017-00831: Poziotinib in EGFR Exon 20 Mutant Advanced NSCLC (clinicaltrials.gov) -  Sep 9, 2021   
    P2,  N=80, Recruiting, 
    Trial completion date: Mar 2021 --> Mar 2023 | Trial primary completion date: Mar 2021 --> Mar 2022
  • ||||||||||  Review, Journal:  Marine Anticancer Agents: An Overview with a Particular Focus on Their Chemical Classes. (Pubmed Central) -  Sep 9, 2021   
    Marine-based pharmaceuticals have started to impact modern pharmacology and different anti-cancer drugs derived from marine compounds have been approved for clinical use, such as: cytarabine, vidarabine, nelarabine (prodrug of ara-G), fludarabine phosphate (pro-drug of ara-A), trabectedin, eribulin mesylate, brentuximab vedotin, polatuzumab vedotin, enfortumab vedotin, belantamab mafodotin, plitidepsin, and lurbinectedin. This review focuses on the bioactive molecules derived from the marine environment with anticancer activity, discussing their families, origin, structural features and therapeutic use.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Journal:  Lurbinectedin: A New Treatment Option for Relapsed/Refractory Small-Cell Lung Cancer. (Pubmed Central) -  Sep 8, 2021   
    With a promising OR compared with other second-line options, lurbinectedin should be considered in patients who have failed first-line therapy. Studies are ongoing with lurbinectedin in combination with other agents in SCLC, and a phase III trial is assessing use in combination with doxorubicin compared with other second-line regimens.
  • ||||||||||  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 Colorectal Cancer (clinicaltrials.gov) -  Aug 30, 2021   
    P2,  N=30, Recruiting, 
    Active, not recruiting --> Completed Trial completion date: Jun 2021 --> Dec 2022 | Trial primary completion date: Apr 2021 --> Apr 2022
  • ||||||||||  Baituowei (goserelin acetate sustained-release microspheres for injection) / Luye Group, BeiGene
    Trial completion, Trial completion date, Trial primary completion date:  Efficacy and Safety of LY01005 in Patients With Prostate Cancer Compared to ZOLADEX (clinicaltrials.gov) -  Aug 25, 2021   
    P3,  N=290, Completed, 
    Trial completion date: Jun 2021 --> Dec 2022 | Trial primary completion date: Apr 2021 --> Apr 2022 Recruiting --> Completed | Trial completion date: May 2022 --> Mar 2021 | Trial primary completion date: Nov 2021 --> Mar 2021
  • ||||||||||  Irene (pyrotinib) / Jiangsu Hengrui Medicine
    Review, Journal:  New Targets in Lung Cancer (Excluding EGFR, ALK, ROS1). (Pubmed Central) -  Aug 20, 2021   
    The identification of uncommon oncogene drivers is reshaping the diagnostic and therapeutic approach to NSCLC. The introduction of novel highly selective inhibitors is expanding the use of targeted therapies to rare and ultra-rare subsets of patients, further increasing the therapeutic armamentarium of advanced NSCLC.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    ¿Zepzelca? (Twitter) -  Aug 19, 2021   
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    [VIRTUAL] EMERGE 402 Phase 4 Observational Study: Safety and Outcomes in Patients With SCLC Receiving Treatment With Lurbinectedin (ePoster Hall) -  Aug 9, 2021 - Abstract #IASLCWCLC2021IASLC_WCLC_1006;    
    P2
    Table. Primary and Secondary Objectives and Endpoint Assessments in EMERGE 402 Primary objective • Assess effectiveness of lurbinectedin monotherapy by ORR (CR or PR) as assessed by the investigator according to the RECIST v.1.1 in the study population Secondary objectives • Assess other effectiveness measures (OS, PFS, DoR, and DCR) of lurbinectedin monotherapy in the study population • Assess patterns of lurbinectedin utilization (dose and number of lurbinectedin cycles, and previous, concomitant, and subsequent treatments) in the study population • Assess safety and tolerability (SAE and AESI) of lurbinectedin monotherapy in the study population • Assess HRQOL with lurbinectedin monotherapy in the study population using PRO questionnaires (EORTC-QLQ-C30 and EORTC-QLQ-LC13) • Assess time to confirmed response (CR or PR) with lurbinectedin monotherapy in the study population • Assess effectiveness, safety, and HRQOL with lurbinectedin monotherapy in the second-line setting • Assess effectiveness (OS, PFS, ORR, DoR, and DCR) and safety in other subgroups of interest ORR, overall response rate; CR, complete response; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; OS, overall survival; PFS, progression-free survival; DoR, duration of response; DCR, disease control rate; SAE, serious adverse event; AESI, adverse event of special interest; HRQOL, health-related quality of life; PRO, patient-reported outcomes; EORTC-QLQ, European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    [VIRTUAL] Lurbinectedin in Pre - Treated Patients With Small Cell Lung Cancer and Malignant Pleural Mesothelioma in a Real World Setting (ePoster Hall) -  Aug 9, 2021 - Abstract #IASLCWCLC2021IASLC_WCLC_999;    
    (SCLC) (n=105) Erasmus MC (SCLC) (n=43) Metaxas et al. (MPM) (n=42) Erasmus MC (MPM) (n=52) Patients number 105 43 42 52 Treatment line 2-3 3-4 2-3 2-3 Median follow-up 17.1 months 7.2 months NA 7.3 m Median chemotherapy-free interval 3.5 months 1.9 months NA 1.6 months DCR 12 weeks 68% 29% 52% 32% ORR 12 weeks 35% 17% 4% 0% Median PFS 3.5 months 1.5 months 4.1 months 2.8 months Median OS 9.3 months 7.0 months 11.1 months 7.2 months Table 1: comparison of our real-world data to the phase II clinical trials
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS
    [VIRTUAL] Frequency of PIK3CA Mutations and Therapeutic Outcomes in NSCLC (ePoster Hall) -  Aug 9, 2021 - Abstract #IASLCWCLC2021IASLC_WCLC_729;    
    Stage I (n:2) Stage II (n:2) Stage IIIA (n:3) Stage IIIB (n:5) Stage IIIC (n:1) Stage IVA (n:4) Stage IVB (n:8) Curative Intent 1 2 2 3 Surgery/Adjuvant Chemotherapy +/- RT 1 1 Radical RT 1 1 2 Concurrent ChemoRT +/- Durvalumab 2 Recurrence/Progression No Yes Yes Yes Total (n) 1 1 3 Palliative Setting 1 1 2 2 1 4 8 Declined/No further Tx 1 1 2 1 Palliative RT (1st L) 1 1 1 2 Chemotherapy (1st L) 1 1 Chemo + Pembrolizumab (1st L) 1 TKI (1st L) 1 1 1 1 3 Gefitinib 1 1 1 Afatinib 1 1 1 1 Alectinib 1 Immunotherapy (1st L) 1 Nivolumab 1 Pembrolizumab Progression to 1st L No No Yes Yes Yes Yes 2nd Line Tx (n) 2 1 1 2 TKI (2nd L) 1 2 Immunotherapy (2nd L) 1 1 Chemotherapy (2nd L) 1 1 Progression to 2nd L Yes 3rd Line Tx (n) 1 Alive (n:9 - 36%) 1 (50%) 2 (100%) 2 (66%) 0 1 (100%) 0 3 (37.5%) Conclusion PIK3CA mutations did not follow a specific pattern and, despite being associated with other mutations in almost half the cases, they do not seem to influence treatment response or median survival either with TKI or checkpoint inhibitors. Infrequent mutations need to be further assessed to determine their impact while future research should focus on defining the subgroup where inhibitors of the AKT pathway may prove beneficial.
  • ||||||||||  Exkivity (mobocertinib) / Takeda
    [VIRTUAL] Targeting HER2 Exon 20–Mutant Lung Adenocarcinoma with a Novel Tyrosine Kinase Inhibitor, Mobocertinib (Program Auditorium) -  Aug 9, 2021 - Abstract #IASLCWCLC2021IASLC_WCLC_654;    
    Mobocertinib had the lowest HER2 exon 20 insertion IC50 / WT EGFR IC50 ratio of all three HER2 exon 20 insertion mutations compared with osimertinib, poziotinib, afatinib, neratinib, and pyrotinib, indicating that mobocertinib displayed the best selectivity profile in these models and could provide an improved efficacy and safety profile in clinic...We tested three drugs (alisertib, sapanisertib and T-DM1) for combination therapies...Conclusion We demonstrated that mobocertinib showed a robust inhibitory activity against HER2 exon 20 insertion mutations both in vitro and in vivo. Importantly, our study provides a strong rationale for further clinical trials using mobocertinib either alone or in combination with T-DM1 to target HER2-mutant lung cancer.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    [VIRTUAL] Subsequent Systemic Therapy After Lurbinectedin Discontinuation in Patients With Small - cell Lung Cancer (Program Auditorium) -  Aug 9, 2021 - Abstract #IASLCWCLC2021IASLC_WCLC_478;    
    P2
    Table. Efficacy With Lurbinectedin Subsequent therapy (n = 47) No subsequent therapy (n = 58) All patients (N = 105) ORR, n (%) 18 (38.3) 19 (32.8) 37 (35.2) Median duration of response (95% CI), mo 5.5 (2.9, 6.4) 5.3 (3.5, 9.1) 5.3 (4.1, 6.4) Median OS (95% CI), mo 11.9 (7.6, 14.9) 7.3 (4.3, 9.7) 9.3 (6.3, 11.8) ORR, overall response rate; CI, confidence interval; mo, months; OS, overall survival.
  • ||||||||||  poziotinib (HM 78136B) / Spectrum Pharma, Gilotrif (afatinib) / Boehringer Ingelheim
    [VIRTUAL] First - Line Therapy in NSCLC harbouring EGFR or HER2 Exon 20 Insertion Mutation. Hunting for the Best Candidate (ePoster Hall) -  Aug 9, 2021 - Abstract #IASLCWCLC2021IASLC_WCLC_379;    
    Poziotinib (POZ), a new generation tyrosine kinase inhibitor (TKI), is under investigation in first and further-line setting as a potential targeted therapy...Out of 31 5 pts received POZ, 22 CT/CT-IO and 4 other TKIs (afatinib/osimerinib) as first line treatment...Indirect comparation between our pts treated with first line CT/CT-IO or other TKIs versus pts receiving first-line POZ in ZENITH20 Trial-Cohort 3 (EGFR therapy-naïve), the mPFS and DCR seems to favor POZ as best first line treatment in aNSCLC. Further data are needed.
  • ||||||||||  Zaltrap intravitreal (ziv-aflibercept intravitreal) / Regeneron, Sanofi, LY09004 (aflibercept biosimilar) / Luye Group, Ocumension Therap
    Journal:  Analytical comparability assessment on glycosylation of ziv-aflibercept and the biosimilar candidate. (Pubmed Central) -  Jul 28, 2021   
    However, further studies exhibited no differences were observed in the cell-based biological potency and Fc effector function. Moreover, the biosimilar candidate showed a similar pharmacokinetics curve and bioequivalence compared with aflibercept.
  • ||||||||||  poziotinib (HM 78136B) / Spectrum Pharma
    [VIRTUAL] Poziotinib in NSCLC harbouring EGFR or HER2 exon 20 insertion mutation () -  Jul 22, 2021 - Abstract #ESMO2021ESMO_2523;    
    Despite the not significant differences between mOS among cohorts, in the adjusted model we can observe a reduction in risk mortality in the POZ-c compare to NPOZ-c, this to demonstrate the POZ adding value in improving prognosis. Due to the small sample size these data have to be validated in larger cohorts.