- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Afinitor (everolimus) / Novartis, paclitaxel / Generic mfg.
[VIRTUAL] A preclinical model for skin sensitization prediction of antineoplasic drugs. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_3791; Results obtained in this work suggest that pre-clinical assays may predict skin sensitization and be of potential value to predict skin sensitization of antineoplastic drugs before clinical development. Further assessment with in vivo tests will help to identify the cutaneous toxic mechanisms of those non-sensitizing drugs as cetuximab Research Funding: None
- |||||||||| MK-6482 / Merck (MSD), Afinitor (everolimus) / Novartis
[VIRTUAL] Phase III study of the hypoxia-inducible factor 2α (HIF-2α) inhibitor MK-6482 versus everolimus in previously treated patients with advanced clear cell renal cell carcinoma (ccRCC). (Poster Board 163) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1054; P3 Key secondary endpoints include objective response rate, duration of response, patient-reported outcomes, and safety. Research Funding: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA
- |||||||||| Afinitor (everolimus) / Novartis, Lenvima (lenvatinib) / Eisai, Merck (MSD)
[VIRTUAL] Quality-adjusted time without symptoms or toxicity (Q-TWiST) of lenvatinib plus everolimus versus everolimus monotherapy in patients with advanced renal cell carcinoma (RCC). (Poster Board 136) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1027; P1b/2 Within Study 205, lenvatinib+everolimus resulted in a statistically significant and clinically important gain in Q-TWiST vs everolimus alone. Research Funding: Eisai Inc., Woodcliff Lake, NJ, USA, and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
- |||||||||| Afinitor (everolimus) / Novartis, Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
[VIRTUAL] Application of IMDC criteria across first-line (1L) and second-line (2L) therapies in metastatic renal-cell carcinoma (mRCC): New and updated benchmarks of clinical outcomes. (Poster Board 132) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1023; These data provide contemporary benchmarks for OS that may be used for patient counseling and trial design. *Sunitinib, Pazopanib, Cabozantinib †Sunitinib, Pazopanib, Cabozantinib, Axitinib, Lenvatinib NR = Not Reached Research Funding: None
- |||||||||| everolimus / Generic mfg.
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: UNIRAD: Safety Study of Adding Everolimus to Adjuvant Hormone Therapy in Women With High Risk of Relapse, ER+ and HER2- Primary Breast Cancer, Free of Disease After Receiving at Least One Year of Adjuvant Hormone Therapy (clinicaltrials.gov) - Apr 28, 2020 P3, N=1279, Active, not recruiting, Additional biomarker studies are planned to look for subgroups that may have a benefit. Recruiting --> Active, not recruiting | N=1984 --> 1279 | Trial completion date: Jun 2031 --> Apr 2025 | Trial primary completion date: Jun 2021 --> Dec 2020
- |||||||||| Ibrance (palbociclib) / Pfizer
Enrollment closed, Trial primary completion date, Combination therapy, Metastases: Palbociclib With Everolimus + Exemestane In BC (clinicaltrials.gov) - Apr 28, 2020 P1b/2a, N=41, Active, not recruiting, Recruiting --> Active, not recruiting | N=1984 --> 1279 | Trial completion date: Jun 2031 --> Apr 2025 | Trial primary completion date: Jun 2021 --> Dec 2020 Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2019 --> Jan 2021
- |||||||||| Afinitor (everolimus) / Novartis
Continuation of mTOR Inhibition in LAM Patients Listed for Lung Transplant is Safe () - Apr 26, 2020 - Abstract #ISHLT2020ISHLT_937; Three were on sirolimus prior to listing; in two of those patients, sirolimus was switched to everolimus at time of listing...Conclusion While controversy abounds regarding the use of mTOR inhibitors during while listed for LTX in LAM patients, this case series suggest that continuation of mTOR inhibitor during waitlist phase before LTX is reasonable and safe. Programs should consider allowance of mTOR inhibition in LAM patients on the LTX waitlist.
- |||||||||| Afinitor (everolimus) / Novartis
Survival in Lung Transplant Recipients on a Calcineurin Free Regimen: Is It Possible? () - Apr 26, 2020 - Abstract #ISHLT2020ISHLT_769; Methods An IRB-approved, retrospective, observational, cohort study of LTx recipients who received CNI-free, everolimus (EVR)-based immunosuppression at the University of Colorado from January 1, 1995 - October 1, 2019...Five of 12 were maintained on three agents (EVR, corticosteroid, and either methotrexate or azathioprine) and the others were on corticosteroids with EVR alone...Conclusion This review demonstrates that in certain situations withdrawal of CNI and transition to CNI-free, EVR- based immunosuppression may result in durable patient survival. Larger multicenter cohort analysis may be the next step in understanding the safety, efficacy and role of CNI-free immunosuppression, as equipoise would be impossible to achieve in a randomized controlled trial.
- |||||||||| Afinitor (everolimus) / Novartis, sirolimus / Generic mfg., University of Cincinnati
Comparative Outcomes of Maintenance Immunosuppression Regimens in Heart Transplantation: Insights from Network Meta-Analysis () - Apr 26, 2020 - Abstract #ISHLT2020ISHLT_279; CNI+ mTA ranked better for CAV (p=0.78), CNI+AM for acute rejection (p=0.96) and mTA+AM for CMV infection (p=0.94) and improvement in renal function (p=0.86) than other regimens. Conclusion Different IS regimens have similar effects on survival post HT, but CNI+ mTA was associated with lower CAV rates, CNI+AM with less rejection, and mTA+AM with less CMV infection and improved eGFR post HT.
- |||||||||| tacrolimus / Generic mfg., Afinitor (everolimus) / Novartis
The TEAMMATE Trial: Study Design and Rationale of the First Pediatric Heart Transplant Randomized Clinical Trial () - Apr 26, 2020 - Abstract #ISHLT2020ISHLT_13; In recent years, everolimus (EVL) has emerged as an alternative to tacrolimus (TAC) as a primary immunosuppressant to prevent rejection that may also prevent kidney and coronary disease...Methods The TEAMMATE Trial (IND 127980) is designed to evaluate the safety and efficacy of EVL and low-dose (LD-TAC) compared to standard-therapy TAC and mycophenolate mofetil (MMF)...Conclusion The TEAMMATE trial is the first RCT in pediatric HT. It is anticipated that the study will provide important information about the safety and effectiveness of EVL and TAC and provide valuable lessons into the design and conduct of future trials in pediatric HT.
- |||||||||| everolimus / Generic mfg.
Journal: Upregulation of miR-101 during Influenza A Virus Infection Abrogates Viral Life Cycle by Targeting mTOR Pathway. (Pubmed Central) - Apr 25, 2020 Moreover, treatment of the cells with Everolimus, a potent inhibitor of mTOR, resulted in an increase of miR-101 transcript levels, which further suppressed the viral protein synthesis. Collectively, the data suggest a novel mechanism that IAV stimulates mTOR pathway at early stages of infection; however, at a later time-point, positive regulation of miR-101 restrains the mTOR expression, and hence, the viral propagation.
- |||||||||| Afinitor (everolimus) / Novartis
mTORC1 inhibition promotes human Treg differentiation via privileged mRNA translation (Board Number: P803) - Apr 25, 2020 - Abstract #IMMUNOLOGY2020IMMUNOLOGY_2313; To answer this question, we performed genome-wide transcription and translation profiling in CD4+CD127dim/-CD25+ Tregs derived from anti-CD3/CD28-activated human naïve CD4+ T cells, treated with the mTORC1 inhibitor RAD001 and/or TGFβ...These canonical Treg fate-determining mRNAs were resistant to mTORC1 inhibition, an effect mediated in part by their 5’-untranslated regions through an alternate form of appears to be cap-dependent, eIF4E-independent mRNA translation. In conclusion, TGFβ transcriptional reprogramming together with mTORC1-independent translational reprogramming enable a privileged translation mechanism by which activated CD4+ T cells become Tregs.
- |||||||||| Afinitor (everolimus) / Novartis
Journal: New anti-epileptic drugs in Paediatrics (Pubmed Central) - Apr 23, 2020 These new molecules have been developed in order to provide a pharmaceutical profile and tolerance superior to the previously available drugs, and it is forecast that as their use increases, their true potential and profile will widen. Furthermore, for the first time in Paediatric Epileptology, the extrapolation of the efficacy data in adults have been used (together with specific safety and pharmacokinetic studies in the paediatric population), in order to speed up their approval for use in the child population.
- |||||||||| Afinitor (everolimus) / Novartis
Journal: Preparation and study of two kinds of ophthalmic nano-preparations of everolimus. (Pubmed Central) - Apr 22, 2020 Micelles could be achieved in the eye and maintained for a long time. The preparation of everolimus micelles or nanosuspension for eye are suitable for ocular administration and expected to be new dosage form for corneal transplantation immunological rejection or other ocular disease.
- |||||||||| Afinitor (everolimus) / Novartis
Clinical, Review, Journal, PD(L)-1 Biomarker, IO Biomarker: mTOR Links Tumor Immunity and Bone Metabolism: What are the Clinical Implications? (Pubmed Central) - Apr 22, 2020 Furthermore, inhibitors of mammalian target of rapamycin are demonstrated to actively modulate osteoclastogenesis, exert antiapoptotic and pro-differentiative activities in osteoclasts, and reduce the number of lytic bone metastases, increasing bone mass in tumor-bearing mice. With regard to the many actions in which mTOR is involved, the aim of this review is to describe its role in the immune system and bone metabolism in an attempt to identify the best strategy for therapeutic opportunities in the metastatic phase of solid tumors.
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