everolimus / Generic mfg. - LARVOL DELTA

Lenvatinib and Everolimus in Renal Cell Carcinoma (RCC) (clinicaltrials.gov) - P1 | N=11 | Completed | Sponsor: Yousef Zakharia | Active, not recruiting ➔ Completed | Trial completion date: Jun 2028 ➔ Aug 2024

Trial completion • Trial completion date • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

SIMRISE: A randomized phase III trial evaluating SIM0270 in combination with everolimus versus treatment of physician's choice in patients with ER+/HER2- advanced breast cancer, previously treated with CDK4/6 inhibitors. (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT06680921 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Combination therapy • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Examination of Immunosuppression Adjustment Impact on Kidney Function in Liver Transplant (clinicaltrials.gov) - P4 | N=71 | Completed | Sponsor: Fady M Kaldas, M.D., F.A.C.S. | Recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Sep 2024 | Trial primary completion date: Dec 2023 ➔ Sep 2024

Trial completion • Trial completion date • Trial primary completion date • Hepatology • Transplantation

CONTRAC: Cemiplimab in AlloSCT/SOT Recipients With CSCC (clinicaltrials.gov) - P1/2 | N=12 | Completed | Sponsor: Dana-Farber Cancer Institute | Active, not recruiting ➔ Completed | Trial completion date: Jan 2026 ➔ Mar 2025

Trial completion • Trial completion date • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Transplantation

Anlotinib plus everolimus as first-line treatment for advanced non–clear cell renal cell carcinoma: 1 year updated results from UC-001, a single-center, single-arm, phase II trial. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT05124431 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Metastases • P2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Non Clear Cell Renal Cell Carcinoma • Oncology • Solid Tumor

Early Access Program in oncology: Retrospective study at a Portuguese hospital (ECOP 2024) - "During the study period were submitted 163 EAP requests for abiraterone, amivantamab, bevacizumab, durvalumab, encorafenib, enfortumab, everolimus, erdafitinib, lenvatinib, lurbinectedin, niraparib, nivolumab, olaparib, pembrolizumab, pertuzumab, ramucirumab, sacituzumab govitecan, selpercatinib, trifluridine/tipiracil, trametinib+dabrafenib, trastuzumab-deruxtecan and tucatinib. Conclusion Most cases correspond to metastatic disease, EAPs facilitate timely access to innovative therapies for patients with high unmet medical needs. The majority of situations were financed, which confirms the importance of EAPs in an era where oncology is constantly innovating."

Retrospective data • Gastrointestinal Disorder • Oncology

Safety and efficacy of everolimus in autoimmune hepatitis – a single center retrospective analysis (EASL 2025) - "Background and Aims: Autoimmune hepatitis (AIH) is a rare autoimmune liver disease that is typically managed with standard steroid- and immunosuppressive regimens including azathioprine, mycofenolate mofetil, tacrolimus or cyclosporine. Everolimus appears to be a safe and effective therapy for AIH in most cases. Larger prospective studies are warranted to confirm these findings and further asses in role in the therapy of AIH."

Retrospective data • Autoimmune Hepatitis • CNS Disorders • Dermatology • Fibrosis • Genetic Disorders • Hematological Disorders • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Oncology • Pneumonia • Pruritus • Renal Disease • Respiratory Diseases • Skin Cancer • Women's Health

Chronic rejection outcomes in pediatric post liver transplantation-single center experience-King Faisal specialist hospital & research center,Riyadh, Saudi Arabia (EASL 2025) - "Six of the 30 patients (20%) achieved a stable remission by immunosuppressive adjustment or adding rescue therapies such as Everolimus or single dose of basliximab... Our data indicate that ductopenia in liver histology predicts a very low chance of reversal of CR upon adaptation of the immunosuppressive regimen. Ductopenia should therefore lead to consider early retransplantation given the increased risk of sepsis and death during intensification of immunosuppression."

Clinical • Hepatology • Infectious Disease • Pediatrics • Septic Shock • Transplant Rejection • Transplantation

Possibility of using the combination of everolimus/sorafenib medications in the treatment of children and adolescents with refractory osteosarcoma and Ewing sarcoma. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Ewing Sarcoma • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

ADELA: A double-blind, placebo-controlled, randomized phase 3 trial of elacestrant (ELA) + everolimus (EVE) versus ELA + placebo (PBO) in ER+/HER2- advanced breast cancer (aBC) patients with ESR1-mutated tumors progressing on endocrine therapy (ET) + CDK4/6i. (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT06382948 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • ER • HER-2

Elacestrant (Ela) combinations with ribociclib (Ribo) and everolimus (Eve) in patients (pts) with ER+/HER2- locally advanced or metastatic breast cancer (mBC): Update from ELEVATE, a phase (Ph) 1b/2, open-label, umbrella study. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT05563220 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

A phase II study of lenvatinib plus everolimus in advanced extra-pancreatic neuroendocrine tumors (epNETs): Updated results and real-world comparison. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT03950609 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Metastases • P2 data • Real-world • Real-world evidence • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor

Idiopathic Subglottic Stenosis Medical Management: A Scoping Review (COSM 2025) - "Results The most reported adjuvant medical therapy used in iSGS is serial intralesional steroid injections (SILSI) (10/16 studies) but current research is investigating everolimus, mitomycin C, rituximab and methotrexate, and lipoaspirate. Further studies are needed to clarify adjuvant protocols for methotrexate, rituximab, everolimus, and lipoaspirate. Use of SILSI alone may offer benefits comparable to adjuvant use, circumventing the need for endoscopic dilation."

Review

The Efficacy of mTOR Inhibitors in Potentiating the Immune Response in TP53 Mutant Head and Neck Squamous Cell Carcinoma (COSM 2025) - "Our findings demonstrate that everolimus exerts enhanced anti-tumor activity in TP53 mutant, HNSCC models with increased cytotoxicity and T-cell infiltration. This suggests that mTORi may augment immune-mediated tumor control by mitigating T-cell exhaustion. These results support further investigation of mTORi as a strategy to enhance the efficacy of immunotherapy in HNSCC, particularly in patients with tumors exhibiting an immunogenic phenotype."

Clinical • IO biomarker • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • TP53

Validation of a 15-Gene Prognostic Signature in Metastatic Clear Cell Renal Cell Carcinoma (AUA 2025) - "Treatment and control arms from all trials were included and grouped within treatment groups which included atezolizumab, atezolizumab plus bevacizumab, sunitinib, avelumab plus axitinib, nivolumab, and everolimus. The 15G score was independently prognostic in metastatic ccRCC among a diverse cohort of patients receiving different systemic therapy regimens."

Metastases • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor • Urology

Neratinib Alone or in Combination with Immune Checkpoint Inhibitors with or without Mammalian Target of Rapamycin Inhibitors in Patients with Fibrolamellar Carcinoma. (PubMed, Liver Cancer) - "Patients received neratinib 240 mg/day orally in SUMMIT, or as doublet or triplet combinations with pembrolizumab 2 mg/kg intravenously every 3 weeks, nivolumab 240 mg intravenously every 2 weeks, everolimus 7.5 mg/day orally, or sunitinib 37.5 mg/day orally under compassionate use. There were no grade 4 adverse events with combination therapy. In patients with FLC, single-agent neratinib had limited efficacy, but clinical benefit was observed with neratinib in combination with immunotherapy and/or mTOR-targeted agents."

Checkpoint inhibition • Journal • Diabetes • Hepatocellular Cancer • Hepatology • Liver Failure • Oncology • HER-2

Triple negative breast cancer (TNBC) PDX models for preclinical investigation of novel therapies (AACR 2025) - "They were phenotypically characterized and screened for their dug sensitivity to standard of care and targeted drugs (e.g. docetaxel, paclitaxel, bevacizumab, everolimus)...These models were treated with nivolumab and pembrolizumab, to evaluate response to these check point inhibitors. In summary, our extensively characterized cohort of TNBC PDX reflects the clinical disease situation and can been successfully applied as translational tool for the assessment of determinants for metastasis, tumor progression and drug responsiveness or resistance. Furthermore, TNBC PDX models are applicable for immune-therapeutic testing including combination settings to evaluate novel therapies for TNBC."

Preclinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRAF • BRCA • HER-2 • PGR • PTEN • TP53

ET-Based Combinations and Novel Agents in HR+/HER2- Advanced Breast Cancer (GBCC 2025) - "Tumors with alterations in the PIK3CA/AKT/PTEN pathway may be offered a pathway inhibitor such as capivasertib or alpelisib, and patients with high risk recurrence of HR+ disease with a PIK3CA mutation may benefit from early introduction of a first-line inavolisib triplet...The oral SERD elacestrant is approved as monotherapy in pretreated patients with tumors harboring an ESR1 mutation. Additional oral SERDs, including imlunestrant, camizestrant, and giredestrant, have demonstrated activity and are in registrational trials. An additional maneuver in the pretreated space includes continuation of a CDK4/6 inhibitor after prior CDK4/6 inhibitor, with activity seen from switching to abemaciclib or ribociclib from a prior agent, and novel CDK inhibitors are in trials as a next generation approach. The mTOR inhibitor everolimus remains an option for pretreated patients as well, particularly when actionable mutations are not present. The continued introduction of novel agents..."

Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PIK3CA

Sunshine Biopharma Launches Everolimus In Canada, an Oncology Drug with an Estimated Global Market of $2.5 Billion (ACCESSWIRE) - "Sunshine Biopharma...announced that its wholly owned Canadian subsidiary, Nora Pharma Inc., has launched Everolimus in the Canadian generic prescription drugs market. Everolimus is a generic equivalent of the brand name Afinitor. Everolimus is indicated for the treatment of (i) advanced renal cell carcinoma, (ii) breast cancer in post-menopausal women with advanced HER2-negative genotype, (iii) progressive well or moderately differentiated neuroendocrine tumors of pancreatic, gastrointestinal or lung origin, and (iv) subependymal giant cell astrocytoma associated with tuberous sclerosis complex. Nora Pharma's Everolimus is available in strengths of 2.5 mg, 5 mg, and 10 mg and comes in blister packs of 30 tablets."

Generic launch • HER2 Negative Breast Cancer • Neuroendocrine Tumor • Renal Cell Carcinoma • Subependymal Giant Cell Astrocytoma

A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread (clinicaltrials.gov) - P1 | N=198 | Active, not recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • CDK6 • HER-2

Differential benefit of adjuvant everolimus according to endocrine therapy backbone in the randomized UNIRAD trial. (PubMed, ESMO Open) - "The present post hoc analyses generate hypotheses regarding the interaction between menopausal status, tamoxifen, and everolimus in patients with high-risk, ER-positive, human epidermal growth factor receptor type 2-negative early breast cancer. They suggest that tamoxifen alone is an underpowered endocrine treatment in high-risk premenopausal patients."

Clinical • Journal • Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Istiratumab exhibits antiproliferative activity in Ewing sarcoma and rhabdomyosarcoma (AACR 2025) - "Istiratumab inhibits ligand binding to abrogate PI3K/AKT signaling resulting in antiproliferative activity in various cancers alone and in combination with mTOR inhibitor everolimus or chemotherapy, including in a human Ewing sarcoma model...Antiproliferative effects of istiratumab were enhanced by addition of NT219 at 0.1 μM or panobinostat in the 3 Ewing sarcoma cell lines tested... Istiratumab has antiproliferative activity in sarcomas and will be evaluated in molecularly selected pediatric malignancies and Ewing sarcoma within the AcSé-ESMART trial."

Brain Cancer • CNS Tumor • Ependymoma • Ewing Sarcoma • Glioma • Hepatoblastoma • Malignant Glioma • Nasopharyngeal Carcinoma • Neuroblastoma • Oncology • Osteosarcoma • Pancreatic Cancer • Rhabdomyosarcoma • Sarcoma • Solid Tumor • ERBB3 • IGF1 • IGF2 • IRS1 • IRS2 • NRG1

A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer) (clinicaltrials.gov) - P3 | N=320 | Active, not recruiting | Sponsor: Genentech, Inc. | Trial completion date: Mar 2026 ➔ Oct 2026 | Trial primary completion date: Mar 2026 ➔ Oct 2026

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2

CEP55, A Promising Prognostic Biomarker for Pancreatic Neuroendocrine Neoplasms, Promotes Tumor Progression Through Activation of PI3K/AKT/mTOR Pathway. (PubMed, FASEB J) - "Everolimus, an mTOR inhibitor, was shown to counteract the effects of CEP55 overexpression both in vivo and in vitro. In conclusion, CEP55 may enhance the proliferation, invasion, and migration of pNENs by activating the PI3K/AKT/mTOR pathway through its interaction with PI3K. It may serve as a valuable prognostic marker and a promising therapeutic target."

Biomarker • Journal • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor • BIRC2 • CEP55

Disproportionality analysis of interstitial lung disease associated with novel antineoplastic agents during breast cancer treatment: a pharmacovigilance study. (PubMed, EClinicalMedicine) - "We identified 9 agents with reporting signals for ILD in FAERS: ROR and 95% confidence interval (CI) for trastuzumab deruxtecan was 12.17 (95% CI 11.04-13.41), atezolizumab 6.04 (5.02-7.28), everolimus 3.21 (2.95-3.50), abemaciclib 2.87 (2.52-3.27), pertuzumab 2.84 (2.49-3.25), olaparib 2.29 (1.65-3.19), trastuzumab emtansine 2.27 (1.91-2.69), pembrolizumab 2.06 (1.65-2.58), and trastuzumab 1.36 (1.25-1.49). These findings highlight the need for vigilant ILD monitoring but require validation through prospective studies to clarify true clinical risks. None."

Adverse events • Journal • Breast Cancer • Interstitial Lung Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor