everolimus / Generic mfg. 
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  • ||||||||||  everolimus / Generic mfg.
    The TEAMMATE Trial: Everolimus to Prevent Rejection in Children After Cardiac Transplantation (Main Event I) -  Oct 12, 2023 - Abstract #AHA2023AHA_8540;    
    The results have the potential to change the standard approach to immunosuppression for children and young adults and lead to FDA approval of the first rejection prophylaxis regimen for pediatric heart transplantation. (Supported by DoD W81XWH-17-1-0532, NCT 03386539)
  • ||||||||||  letrozole / Generic mfg., everolimus / Generic mfg.
    Trial completion date, Trial primary completion date, Metastases:  Letrozole and RAD001 With Advanced or Recurrent Endometrial Cancer (clinicaltrials.gov) -  Oct 10, 2023   
    P2,  N=42, Active, not recruiting, 
    Forty five percent received a therapy adapted to a genomic alteration with a clinical benefit in one third of them. Trial completion date: Apr 2023 --> Apr 2028 | Trial primary completion date: Apr 2022 --> Apr 2028
  • ||||||||||  Clinicopathologic feature and treatment outcome of metastatic non clear cell kidney cancer: A single centre experience from India (Exhibition area) -  Oct 6, 2023 - Abstract #ESMOAsia2023ESMO_Asia_803;    
    Majority received pazopanib 46% (n=30) then chemotherapy 20% (n=13) including bevacizumab plus erlotinib, sunitinib 15%(10), cabozantinib 14%(9)...Total 17 (26%) patients required dose reduction & interruption due to adverse effects & 33% received second-line therapy with nivolumab,axitinib & everolimus were commonly used...Regression analysis identified better outcome for PFS & OS with sarcomatoid subtype & those underwent prior nephrectomy. Conclusions The overall response and survival was quite impressive in comparison with published data; despite limited number of cases treated with IO due to its cost.This study also highlighted better survival with sarcomatoid subtype and prior nephrectomy.
  • ||||||||||  sirolimus / Generic mfg.
    Journal:  Blazing a trail for the clinical use of rapamycin as a geroprotecTOR. (Pubmed Central) -  Oct 6, 2023   
    Here, we highlight ongoing or upcoming clinical trials that will address outstanding questions regarding the safety, pharmacokinetics, pharmacodynamics, and efficacy of rapamycin and rapalogs on several clinically oriented outcomes. Results from these early phase studies will help guide the design of phase 3 clinical trials to determine whether rapamycin can be used safely to inhibit mTORC1 for the treatment and prevention of age-related diseases in humans.
  • ||||||||||  Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
    Trial completion:  Treg Modulation With CD28 and IL-6 Receptor Antagonists (clinicaltrials.gov) -  Oct 6, 2023   
    P1/2,  N=10, Completed, 
    Results from these early phase studies will help guide the design of phase 3 clinical trials to determine whether rapamycin can be used safely to inhibit mTORC1 for the treatment and prevention of age-related diseases in humans. Active, not recruiting --> Completed
  • ||||||||||  Review, Journal, PD(L)-1 Biomarker, IO biomarker, Metastases:  Systemic Treatment for Advanced and Metastatic Non-Clear Cell Renal Cell Carcinoma: Examining Modern Therapeutic Strategies for a Notoriously Challenging Malignancy. (Pubmed Central) -  Oct 4, 2023   
    Vascular endothelial growth factor tyrosine kinase inhibitors (TKI), such as sunitinib, and mammalian target of rapamycin (mTOR) inhibitors, such as everolimus, have demonstrated efficacy and remain viable treatment options, with a preference for sunitinib...Clinically meaningful antitumor activity has been observed across all non-clear cell histologies for immune checkpoint inhibitors, such as nivolumab, pembrolizumab, and ipilimumab. Ongoing trials are evaluating novel tyrosine kinase inhibitor and immunotherapy combination regimens, with an emphasis on the promising MET-inhibitor cabozantinib and pembrolizumab plus lenvatinib.
  • ||||||||||  Trial completion date, Trial primary completion date, Tumor mutational burden:  The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy (clinicaltrials.gov) -  Oct 3, 2023   
    P2,  N=400, Active, not recruiting, 
    Furthermore, down-regulation of DDIT4, DEPTOR, HIF1A, and PLD1 may contribute to everolimus resistance. Trial completion date: Aug 2024 --> Jun 2025 | Trial primary completion date: Apr 2024 --> Dec 2024
  • ||||||||||  camizestrant (AZD9833) / AstraZeneca
    Trial completion, Combination therapy, Metastases:  AZD9833 China PK Study (clinicaltrials.gov) -  Oct 3, 2023   
    P1,  N=28, Completed, 
    Trial completion date: Aug 2024 --> Jun 2025 | Trial primary completion date: Apr 2024 --> Dec 2024 Recruiting --> Completed
  • ||||||||||  rocapuldencel-T (CMN-001) / CoImmune, SCM Lifescience
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Metastases:  Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma (clinicaltrials.gov) -  Oct 2, 2023   
    P2b,  N=16, Terminated, 
    Recruiting --> Completed N=120 --> 16 | Trial completion date: Mar 2024 --> Sep 2023 | Recruiting --> Terminated | Trial primary completion date: Mar 2024 --> Sep 2023; Strategic corporate decision
  • ||||||||||  Talzenna (talazoparib) / Pfizer, bemcentinib (BGB324) / BerGenBio
    This contribution has been withdrawn. (X4) -  Sep 30, 2023 - Abstract #DGHO2023DGHO_692;    
    The loss of STK11 or KEAP1 should be interpreted in the context of KRAS mutational and could be a clinical biomarker for poor response to targeted therapy in patients with advanced NSCLC. The data highlight that in addition to established biomarkers such as PD-L1, new potential marker of resistance such as STK11 or KEAP1 should be considered in molecular analysis prior to therapy initiation.
  • ||||||||||  Sutent (sunitinib) / Pfizer
    Journal, Metastases:  Systemic Therapy for Tumor Control in Metastatic Well-Differentiated Gastroenteropancreatic Neuroendocrine Tumors: ASCO Guideline. (Pubmed Central) -  Sep 29, 2023   
    Qualifying statements are provided to assist with treatment choice. Multidisciplinary team management is recommended, along with shared decision making with patients, incorporating their values and preferences, potential benefits and harms, and other characteristics and circumstances, such as comorbidities, performance status, geographic location, and access to care.Additional information is available at www.asco.org/gastrointestinal-cancer-guidelines.
  • ||||||||||  dordaviprone (ONC201) / Chimerix
    Journal, Metastases:  ONC201/TIC10 enhances durability of mTOR inhibitor everolimus in metastatic ER+ breast cancer. (Pubmed Central) -  Sep 29, 2023   
    Transcriptomic analysis in everolimus resistant breast patient tumors and mitochondrial functional assays in resistant cell lines demonstrated increased mitochondrial respiration dependency, contributing to ONC201/TIC10 sensitivity. We propose that ONC201/TIC10 and modulation of mitochondrial function may provide an effective add-on therapy strategy for patients with metastatic ER+ BCs resistant to mTOR inhibitors.
  • ||||||||||  B Predicting Response To Chemotherapy In Recurrent High Grade Gliomas Usingex Vivo (Grote Zaal Foyer) -  Sep 28, 2023 - Abstract #EANO2023EANO_318;    
    In our experience, this platform is easy to use in a standard clinical setting, the success rate for creating viable spheroids for testing is high and the information derived from the drug sensitivity testing can be useful in clinical practice. Large, prospective clinical trial is need to validate this approach for routine clinical use.
  • ||||||||||  Torisel (temsirolimus) / Pfizer
    Review, Journal:  The Role of mTOR in B Cell Lymphoid Malignancies: Biologic and Therapeutic Aspects. (Pubmed Central) -  Sep 28, 2023   
    This review is mainly focused on the PI3K/v-akt/mTOR pathway-related oncogenic mechanisms in B cell NHLs with an emphasis on common B cell lymphoma types [diffuse large B cell lymphoma (DLBCL) and mantle cell lymphoma (MCL)]. Furthermore, it summarizes the literature regarding the clinical applications of the mTOR inhibitors temsirolimus and everolimus in B cell NHLs, which have been tested in a range of clinical trials enrolling patients with B cell malignancies, either as monotherapy or in combination with other agents or regimens.
  • ||||||||||  Review, Journal:  Pharmacomicrobiomics of Classical Immunosuppressant Drugs: A Systematic Review. (Pubmed Central) -  Sep 28, 2023   
    Potential effects on cIMD pharmacokinetics, efficacy or tolerability were observed in 17/20 papers evaluating this issue, in particular with tacrolimus, cyclosporine, mycophenolic acid and corticosteroids, whereas evidence was missing for everolimus and sirolimus...However, no unique pattern of microbiota modification was observed across the different studies. In conclusion, the available evidence supports the hypothesis that intestinal microbiota could contribute to the variability in the response to some cIMDs, whereas data are still missing for others.
  • ||||||||||  Kisqali (ribociclib) / Novartis
    Trial completion date, Trial initiation date, Trial primary completion date:  Study of Ribociclib and Everolimus in HGG and DIPG (clinicaltrials.gov) -  Sep 28, 2023   
    P2,  N=100, Not yet recruiting, 
    In conclusion, the available evidence supports the hypothesis that intestinal microbiota could contribute to the variability in the response to some cIMDs, whereas data are still missing for others. Trial completion date: Aug 2033 --> Jan 2034 | Initiation date: Aug 2023 --> Jan 2024 | Trial primary completion date: Aug 2027 --> Jan 2028
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS
    SLAMF7+ CD8+ exhausted T cell-specific gene signature is associated with resistance to PD1 blockade in renal cell carcinoma (Exhibit Hall B) -  Sep 27, 2023 - Abstract #SITC2023SITC_1325;    
    P2
    Conclusions We present a GES characteristic of SLAMF7+ CD8+ exhausted T cells that is associated with worse clinical outcomes in patients receiving anti-PD1 monotherapy, but not in patients receiving mTOR inhibitor monotherapy. Future work will aim to validate our findings in additional external RCC cohorts, examine the applicability of our findings to additional cancer types, and experimentally interrogate the impact of SLAMF7 signaling on CD8+ T cell function.
  • ||||||||||  everolimus / Generic mfg.
    Journal:  Present state of intestinal transplantation in Japan. (Pubmed Central) -  Sep 27, 2023   
    Future work will aim to validate our findings in additional external RCC cohorts, examine the applicability of our findings to additional cancer types, and experimentally interrogate the impact of SLAMF7 signaling on CD8+ T cell function. The results of ITx are acceptable to treat IF patients and the QOL after transplantation is also good.
  • ||||||||||  Bay11-7082 / Bayer
    Preclinical, Journal:  An mTORC1-Dependent Mouse Model for Cardiac Sarcoidosis. (Pubmed Central) -  Sep 26, 2023   
    Conclusions To our best knowledge this is the first animal model of cardiac sarcoidosis that recapitulates major pathological hallmarks of human disease. mTOR inhibition may be a therapeutic option for patients with cardiac sarcoidosis.
  • ||||||||||  Ostarine (enobosarm) / Veru Inc
    Trial completion date, Trial primary completion date, Monotherapy, Metastases:  ARTEST: Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer (clinicaltrials.gov) -  Sep 25, 2023   
    P3,  N=210, Active, not recruiting, 
    Treatment with rapamycin reduced neurological deficient, oxidative stress, and inflammation in a rat model of intracerebral hemorrhage. Trial completion date: Jul 2023 --> Feb 2024 | Trial primary completion date: Jun 2023 --> Jan 2024