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  • ||||||||||  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.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Journal:  AHFS®first Release™. (Pubmed Central) -  Jul 21, 2021   
    Study is ongoing with BID dosing currently. No abstract available
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Trial completion, Trial completion date, Trial primary completion date, Monotherapy:  SAKK 17/16: Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma. (clinicaltrials.gov) -  Jul 14, 2021   
    P2,  N=42, Completed, 
    Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial completion date: Mar 2022 --> Jun 2021 | Trial primary completion date: Apr 2019 --> Jun 2021
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Clinical, Journal:  Lurbinectedin in Refractory Diffuse Malignant Peritoneal Mesothelioma: Report of Two Cases. (Pubmed Central) -  Jul 6, 2021   
    However, until present, no data have been available for patients with MPM and for patients who become refractory after multiple treatment lines. We report on two patients with metastatic MPM who achieved durable disease control of 10+ and 8 months with lurbinectedin in the fourth and fifth treatment line, respectively.
  • ||||||||||  poziotinib (HM 78136B) / Spectrum Pharma, Tagrisso (osimertinib) / AstraZeneca, Gilotrif (afatinib) / Boehringer Ingelheim
    Clinical, Journal, EGFR exon 20:  Variability of EGFR exon 20 insertions in 24,468 Chinese lung cancer patients and their divergent responses to EGFR inhibitors. (Pubmed Central) -  Jul 2, 2021   
    Poziotinib achieved higher DCR for p.S768_D770dup than for p.A767_V769dup, whereas osimertinib showed limited effects for these two insertions when used as the first-line treatment. Overall, our results demonstrated that EGFR e20ins were highly diversified in terms of insertion patterns and co-occurring mutations and these EGFR e20ins variants showed different clinical responses to various EGFR TKIs, suggesting the clinical importance of selecting proper EGFR TKI treatment based on the specific EGFR e20ins type.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Review, Journal:  Lurbinectedin: First Approval. (Pubmed Central) -  Jun 30, 2021   
    Clinical investigation in other solid cancers is ongoing. This article summarizes the milestones in the development of lurbinectedin leading to this first approval for the treatment of metastatic SCLC.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Journal:  Lurbinectedin for the treatment of small cell lung cancer. (Pubmed Central) -  Jun 28, 2021   
    In 2020, the U.S. Food and Drug Administration (FDA) approved lurbinectedin for the treatment of adult patients with metastatic SCLC or for patients that have received platinum-based chemotherapy. In this review, we discuss the molecular profile and the preclinical and clinical studies of lurbinectedin in the treatment of SCLC patients.
  • ||||||||||  Journal, EGFR exon 20:  Extensive functional evaluation of exon 20 insertion mutations of EGFR. (Pubmed Central) -  Jun 22, 2021   
    EGFR exon 20 insertions were shown to have different degrees of sensitivity to EGFR TKIs. This extensive assessment of EGFR exon 20 insertions may provide a fundamental database for aiding in a customized mode of therapy for cancers having insertional mutations within exon 20 of EGFR, although the clinical impact of preclinical data should be validated by clinical evidence in the future.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Clinical, Journal:  Lurbinectedin-Induced Tumor Lysis Syndrome in Small Cell Neuroendocrine Cancer of the Cecum: A First-Ever Case Report. (Pubmed Central) -  Jun 22, 2021   
    Our patient had a high Ki-67 proliferation index (95%), harbored a huge disease burden, and had bilateral renal metastasis, thus making her more susceptible to develop TLS. CONCLUSIONS Although data regarding the occurrence of TLS due to Lurbi in solid tumors are scarce, it remains a potential complication of Lurbi in neuroendocrine tumors with high proliferation index and large tumor burden.
  • ||||||||||  Lipusu (liposomal paclitaxel) / Luye Group, Cynviloq (paclitaxel polymeric micelle formulation) / Sorrento, Samyang Group, ImmunityBio, Abraxane (albumin-bound paclitaxel) / BMS, Otsuka
    Review, Journal:  A Review on Nano-Based Drug Delivery System for Cancer Chemoimmunotherapy. (Pubmed Central) -  Jun 22, 2021   
    The applications of NDDS to chemoimmunotherapy would be a powerful strategy for future cancer treatment, which could greatly enhance the therapeutic efficacy, reduce the side effects and optimize the clinical outcomes of cancer patients. Herein, the current approaches of cancer immunotherapy and chemoimmunotherapy were discussed, and recent advances of NDDS applied for chemoimmunotherapy were further reviewed.
  • ||||||||||  rotigotine microspheres (LY03009) / Luye Group
    Enrollment open, Trial initiation date:  to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy Volunteers (clinicaltrials.gov) -  Jun 8, 2021   
    P1,  N=40, Enrolling by invitation, 
    To our knowledge, this is the largest report to confirm that the EGFR-A763_Y764insFQEA mutation is sensitive to clinically available first-, second-, third-generation, and in-development EGFR TKIs. Not yet recruiting --> Enrolling by invitation | Initiation date: Oct 2020 --> Feb 2021