everolimus / Generic mfg. 
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  • ||||||||||  everolimus / Generic mfg.
    Clinical, P2 data, Journal:  A phase II study of everolimus in patients with advanced solid malignancies with TSC1, TSC2, NF1, NF2 or STK11 mutations. (Pubmed Central) -  Aug 24, 2021   
    Although this study failed to meet its prespecified ORR threshold for success of 30% or higher, exploratory analyses suggest potential activity for everolimus in a subset of patients with lung adenocarcinomas with STK11 or NF1 mutations. Further studies are necessary to systematically explore the clinical activity of everolimus, potentially as a combination therapy, in these patients.
  • ||||||||||  sirolimus / Generic mfg.
    Review, Journal:  Tuberous Sclerosis Complex: A review of the past, present and future. (Pubmed Central) -  Aug 22, 2021   
    Rapamycin has been FDA approved for lymphangioleiomyomatosis...A multidisciplinary treatment plan based on the specific problems and needs of individuals is key in the management of this genetic condition. Ongoing research studies are providing promising leads for developing novel mechanistic strategies to address the pathophysiology of TSC.
  • ||||||||||  everolimus / Generic mfg.
    Clinical, Journal:  Efficacy of everolimus combined with endocrine therapy in HR-positive/HER-2-negativeadvanced breast cancer. (Pubmed Central) -  Aug 22, 2021   
    Everolimus combined with endocrine therapy has significant clinical efficacy in patients with HR-positive/HER-2-negative advanced breast cancer, and can effectively improve the survival of patients with tolerable adverse reactions. PR+, absence of visceral metastases and sensitivity to endocrine therapy are the protective prognostic factors for PFS.
  • ||||||||||  Avastin (bevacizumab) / Roche
    Journal:  Multivariate saturation treatment for pancreatic neuroendocrine neoplasms with liver metastasis (Pubmed Central) -  Aug 20, 2021   
    As a new tumor treatment concept in the era of intelligent medicine recently proposed by the author, the concept of multivariate saturation treatment used artificial intelligence technology to integrate existing tumor treatment methods, combined with the individual heterogeneity of patients; used the deep learning technology of artificial intelligence to accurately assess disease stages and predict the possible response of the corresponding treatment; used the robotic surgery platform to adopt the most suitable surgical method for the patient, which was dynamically adjusted at different stages of tumor treatment to maximize and optimize the treatment effect. Multivariate saturation treatment can provide the possibility to achieve the optimal prognosis of the patient.
  • ||||||||||  everolimus / Generic mfg.
    Clinical, Journal:  Everolimus for BKV nephropathy in kidney transplant recipients: a prospective, controlled study. (Pubmed Central) -  Aug 20, 2021   
    Kidney transplant recipients on Everolimus had a higher survival free of adverse graft outcome (log-rank test, P = 0.009). In conclusion an Everolimus-based immunosuppressive protocol with minimization of Calcineurin inhibitors and antimetabolite discontinuation effectively treated BKVN in kidney transplant recipients.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Trial completion date, Trial primary completion date, Metastases:  CONTRAC: Cemiplimab in AlloSCT/SOT Recipients With CSCC (clinicaltrials.gov) -  Aug 18, 2021   
    P1,  N=12, Recruiting, 
    No abstract available Trial completion date: Jul 2022 --> Jul 2023 | Trial primary completion date: Jul 2021 --> Jul 2022
  • ||||||||||  everolimus / Generic mfg.
    Trial completion date, Trial primary completion date:  Everolimus for Children With Recurrent or Progressive Ependymoma (clinicaltrials.gov) -  Aug 18, 2021   
    P2,  N=11, Active, not recruiting, 
    Trial completion date: Sep 2021 --> Dec 2021 | Trial primary completion date: Sep 2021 --> Dec 2021 Trial completion date: Jun 2021 --> Dec 2021 | Trial primary completion date: Jun 2021 --> Dec 2021
  • ||||||||||  everolimus / Generic mfg.
    Preclinical, Journal:  Dosing-Time Dependent Testicular Toxicity of Everolimus in Mice. (Pubmed Central) -  Aug 14, 2021   
    Our study revealed dosing-time dependent testicular toxicity of everolimus in mice, which was greater in severity when everolimus administered at early rest-span (daytime-ZT1) than early activity-span (nighttime-ZT13). These findings support the concept of everolimus chronotherapy for minimizing reproductive toxicity and increasing the tolerability of everolimus, as a clinical advantage.
  • ||||||||||  Livalo (pitavastatin) / Kowa, Eli Lilly
    Journal:  Pre-incubation with OATP1B1 and OATP1B3 inhibitors potentiates inhibitory effects in physiologically relevant sandwich-cultured primary human hepatocytes. (Pubmed Central) -  Aug 14, 2021   
    The current study was designed to determine the IC values of OATP1B1 and OATP1B3 inhibitors everolimus (EVR), sirolimus (SIR), and dasatinib against OATP1B substrates in physiologically relevant primary human hepatocytes with or without inhibitor-preincubation and to compare the OATP-mediated DDI prediction using data from primary human hepatocytes and that reported previously in transporter-expressing cell lines...Accumulation of [H]-CCK-8 (1 µM, 1.5 min), [H]-rosuvastatin (0.5 µM, 2 min) and [H]-pitavastatin (1 µM, 0.5 min) was determined in human sandwich-cultured hepatocytes (SCH) in the presence of vehicle control or an inhibitor with or without inhibitor-preincubation at designated concentrations, and was utilized to determine the IC values for these inhibitors...In conclusion, the current study is the first to report that pre-incubation with OATP1B inhibitors potentiates inhibitory effects in physiologically relevant primary human hepatocytes, supporting the rationale of the current US FDA draft guidance of including an inhibitor-preincubation step when assessing OATP-mediated DDIs in vitro. IC values after inhibitor-preincubation in transporter-expressing cell lines may be used for DDI prediction for the purpose of mitigating false-negative OATP-mediated DDI prediction.
  • ||||||||||  Sutent (sunitinib) / Pfizer
    Review, Journal:  Medical Management of Gastroenteropancreatic Neuroendocrine Tumors. (Pubmed Central) -  Aug 13, 2021   
    This article reviews the role of somatostatin analogues, historical results with chemotherapy in gastroenteropancreatic NETs (GEPNETs), and more recent evidence for the use of cytotoxic chemotherapy in GEPNETs. The article also discusses molecular targeted therapies approved for use in GEPNETs and some ongoing clinical trials.
  • ||||||||||  Vistide (cidofovir) / Gilead
    Journal:  T-cell adoptive immunotherapy for BK nephropathy in renal transplantation. (Pubmed Central) -  Aug 13, 2021   
    We conclude that the T-cell adoptive immunotherapy reduced BKPyV load significantly despite extensive infection, but attendant fibrosis and tubular atrophy led to graft failure. Early intervention with T-cell therapy may prove efficacious in BKPyV nephropathy.
  • ||||||||||  everolimus / Generic mfg., sirolimus / Generic mfg.
    Trial completion, Trial completion date, Trial primary completion date:  Glutamine PET Imaging in LAM (clinicaltrials.gov) -  Aug 11, 2021   
    P1,  N=5, Completed, 
    Asymptomatic patients with positive CT findings should be closely monitored to timely initiate specific treatment. Enrolling by invitation --> Completed | Trial completion date: Dec 2021 --> Aug 2021 | Trial primary completion date: Oct 2021 --> Jun 2021
  • ||||||||||  everolimus / Generic mfg.
    Trial completion:  Mood and Cognitive Outcome After Heart Transplantation (the MOODHEART Study) (clinicaltrials.gov) -  Aug 9, 2021   
    P=N/A,  N=74, Completed, 
    Enrolling by invitation --> Completed | Trial completion date: Dec 2021 --> Aug 2021 | Trial primary completion date: Oct 2021 --> Jun 2021 Enrolling by invitation --> Completed
  • ||||||||||  sirolimus / Generic mfg.
    Journal:  Hypomorphic mTOR downregulates CDK6 and delays thymic Pre-T LBL tumorigenesis. (Pubmed Central) -  Aug 8, 2021   
    Combined mTOR (rapamycin) and CDK4/6 (palbociclib) inhibition decreased tumor size and proliferation in tumor flank transplants, increased survival in an intravenous transplant model of disseminated leukemia compared to single agent treatment and cooperatively decreased cell viability in human T-ALL/LBL cell lines. Thus, mTOR KD mice provide a model to explore drug combinations synergizing with mTOR inhibitors and can be used to identify downstream targets of inhibition.
  • ||||||||||  sirolimus / Generic mfg.
    Review, Journal:  Review of the treatment options for epilepsy in tuberous sclerosis complex: towards precision medicine. (Pubmed Central) -  Aug 6, 2021   
    These promising results could pave the way for evaluating other treatments in a preventative capacity, especially those that may address the underlying pathophysiology of TSC, including everolimus, cannabidiol and the ketogenic diet (KD)...Highly purified cannabidiol, recently approved in the US as Epidiolex® for TSC-associated seizures in patients ⩾1 years of age, and the KD, may also participate in the regulation of the mTOR pathway...New future therapies are also discussed, together with the potential for preventative treatment with targeted therapies. Due to advances in understanding the molecular genetics and pathophysiology, TSC represents a prototypic clinical syndrome for studying epileptogenesis and the impact of precision medicine.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS
    [VIRTUAL] Genetic Mutations as Prognostic Biomarkers in Metastatic Renal Cell Carcinoma () -  Aug 5, 2021 - Abstract #AUA2021AUA_3292;    
    Substantial but conflicting evidence exists regarding the prognostic value of PBRM-1 LOF mutations, with limited evidence of longer OS or PFS in patients receiving nivolumab (p .05). Overall, we found the strongest consensus for gene mutations in BAP1, CDKN2A, CIMP/FH, and TERT as biomarkers prognostic for OS or PFS, while the prognostic value of PBRM-1, ERV, mTOR, and VHL mutations has yet to be fully elucidated.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS
    [VIRTUAL] Genetic Mutations as Predictive Biomarkers in Metastatic Renal Cell Carcinoma () -  Aug 5, 2021 - Abstract #AUA2021AUA_2954;    
    Mutations in the TERT promoter may be associated with improved response to ICI, while PBRM-1 LOF shows promise for predicting response to specific ICI regimens. Very limited data exist regarding the predictive value of all biomarkers, with further study required to personalize treatment regimens.
  • ||||||||||  Nexavar (sorafenib) / Bayer, Amgen
    [VIRTUAL] Biomarker-targeted novel combination for renal cell carcinoma () -  Aug 5, 2021 - Abstract #AUA2021AUA_2835;    
    By downregulating HAS3 expression, MU+SF combination effectively abrogates RCC growth and metastasis. HAS3 is a potential biomarker to predict clinical outcome in RCC patients.
  • ||||||||||  Tagrisso (osimertinib) / AstraZeneca
    [VIRTUAL] Molecular aspects of resistance to cisplatin and osimertinib in penile cancer (Bellini 2101) -  Aug 5, 2021 - Abstract #AUA2021AUA_2577;    
    Resistance patterns and mechanisms were identified, emphasizing the involvement of the AKT/mTOR signaling pathway and paving the way for development of novel treatment strategies in PeCa. Targeting this pathway might prolong efficacy of therapeutic regimens or induce a re-sensitization of treatment-resistant PeCa cells.