everolimus / Generic mfg. - LARVOL DELTA

Cemiplimab for kidney organ transplant recipients with advanced cutaneous squamous cell carcinoma: CONTRAC-1. (ASCO 2023) - P1 | "For mTOR inhibition, 7 (70%) received sirolimus and 3 (30%) everolimus...One KTR with initial PD experienced a subsequent durable response to cetuximab... Using IS with mTOR inhibition and dynamic prednisone resulted in no kidney allograft rejection among KTRs treated with Cemi for advanced cSCC. Durable anti-tumor efficacy was observed. mTOR inhibition with prednisone should be the preferred IS regimen when treating KTRs with anti-PD-1 therapy."

Clinical • IO biomarker • Metastases • Fatigue • Infectious Disease • Non-melanoma Skin Cancer • Oncology • Solid Organ Transplantation • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Transplant Rejection • Transplantation • CDKN2A • NOTCH1 • PD-L1 • TP53

Fruquintinib (FRUQ) plus sintilimab (SIN) versus axitinib (AXI) or everolimus (EVE) monotherapy as 2L treatment in pts with locally advanced or metastatic renal cell carcinoma (RCC): Results from phase III part of a randomized, open-label, active-controlled phase II/III study (FRUSICA-2) (ESMO 2025) - P2/3 | "The incidences of grade ≥3 TEAEs (71.4% vs 58.8%), TEAEs leading to treatment discontinuation (17.6% vs 9.6%), and fatal TEAEs (4.2% vs 4.4%) were comparable between groups. Table: 2592MO Efficacy Results by IMDC Prognostic Risk ITT set (BIRC-assessed) IMDC risk factor Number of IMDC risk factor Favorable-risk Intermediate-risk Poor-risk 0-1 risk factors FRUQ+ SIN N=33 AXI/EVE N=32 FRUQ+ SIN N=73 AXI/EVE N=72 FRUQ+ SIN N=13 AXI/EVE N=11 FRUQ+ SIN N=76 AXI/EVE N=73 mPFS, months NR 8.31 22.21 6.97 9.69 4.21 24.87 8.31 Unstratified HR (95% CI) 0.270 (0.117, 0.620) 0.352 (0.221, 0.562) 0.591 (0.203, 1.721) 0.278 (0.168, 0.461) Unstratified log-rank p * 0.0009 <0.0001 0.3267 <0.0001 ORR (%) 63.6 25.0 61.6 23.6 46.2 27.3 63.2 26.0 Odds ratio (95% CI) 5.250 (1.608, 17.712) 5.200 (2.394, 11.435) 2.286 (0.315, 19.098) 4.872 (2.292, 10.456) p * 0.0019 <0.0001 0.3514 <0.0001 *Two-sided Conclusions FRUQ+SIN demonstrated superior mPFS and manageable safety compared..."

Clinical • Metastases • Monotherapy • P2/3 data • P3 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Fruquintinib monotherapy as second-line (2L) treatment in locally advanced or metastatic renal cell carcinoma (RCC): Results from phase II part of FRUSICA-2 (ESMO Asia 2025) - P2/3 | "Background: FRUSICA-2 is a randomized, open-label, active-controlled phase 2/3 study (NCT05522231) designed to evaluate the efficacy and safety of Fruquintinib (F) + Sintilimab versus Axitinib or Everolimus monotherapy for 2L treatment of RCC. Results from this F monotherapy of the FRUSICA-2 indicated a comparable anti-tumor efficacy compared with other 2L VEGFR-TKI monotherapies, along with a manageable safety profile in 2L RCC pts after first-line VEGFR-TKI therapy."

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

Elacestrant in combination with everolimus or abemaciclib in patients with ER+/HER2- locally advanced or metastatic breast cancer (mBC): phase 2 results from ELEVATE, an open-label, umbrella study (SABCS 2025) - " ELEVATE is evaluating elacestrant combined with everolimus, alpelisib, capivasertib, abemaciclib, ribociclib,or palbociclib to address different resistance mechanisms...PFS benefit was consistent across subgroups, including those with visceral metastases, prior fulvestrant or primary ET resistance... Elacestrant in combination shows a consistent PFS benefit irrespective of ESR1m status in pts with ER+/HER2-mBC after progressive disease on ET ± prior CDK4/6i. Elacestrant has the potential to become an ET backbone for combination strategies with targeted agents, supporting an all-oral approach that may delay the need for chemo or ADC-based regimens in this patient population. Table 1:Phase 2 mPFS, mo[95% CI] in all patients and subgroupsNR, not reached"

Clinical • Combination therapy • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • ER • HER-2 • PIK3CA

Elacestrant (Ela) in combination with everolimus (Eve) or abemaciclib (Abema) in patients with ER+/HER2- locally advanced or metastatic breast cancer mBC: phase 2 results from ELEVATE, an open-label, umbrella study (AACR 2026) - "ELEVATE is evaluating Ela combined with Eve, alpelisib, capivasertib, Abema, ribociclib, or palbociclib to address resistance mechanisms. Ela combinations show a consistent clinically meaningful PFS irrespective of ESR1m status in pts with ER+/HER2- mBC after progressive disease on ET ± prior CDK4/6i, and could become an ET backbone for combination strategies, supporting an all-oral approach.NR, not reached *Maturity not reached for PFS (95% CI) for genomic subgroups (ESR1 / PIK3CA) or by prior CDK4/6i exposure."

Clinical • Combination therapy • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • ER • HER-2 • PIK3CA

Imlunestrant with or without everolimus or alpelisib, in ER+, HER2- advanced breast cancer (aBC): Results from the phase Ia/b EMBER study (ESMO 2023) - P1a/1b | "In the first-in-human phase 1a/b EMBER study, imlunestrant demonstrated favorable safety, pharmacokinetics (PK), and clinical benefit rate when administered as monotherapy (Jhaveri ASCO 2022) or with abemaciclib (Jhaveri SABCS 2022)...Median number of prior aBC therapies in combination cohorts was: 1 (range 1-2); including prior ET (100%), CDK4/6i (100%), fulvestrant (35%) and chemo (17%)...Conclusions Imlunestrant alone or in combination with everolimus or alpelisib demonstrated robust efficacy in pts with pre-treated ER+, HER-2 aBC. Toxicities were consistent with the known safety profile of both alpelisib and everolimus."

Metastases • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • CDK4 • ER • HER-2 • PIK3CA

Imlunestrant, an Oral Selective Estrogen Receptor Degrader, as Monotherapy and in Combination With Targeted Therapy in Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Phase Ia/Ib EMBER Study. (PubMed, J Clin Oncol) - "Imlunestrant, as monotherapy or in combination with targeted therapy, had a manageable safety profile with evidence of preliminary antitumor activity in ER+/HER2- ABC."

Combination therapy • Journal • Metastases • Monotherapy • P1 data • Breast Cancer • Endometrial Cancer • Fatigue • 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

Retrospective exploratory biomarker (BM) analyses from evERA Breast Cancer (BC): A Phase III trial of giredestrant (GIRE) + everolimus (E) in patients (pts) with oestrogen receptor-positive, HER2-negative advanced BC (ER+, HER2– aBC) in the post-CDK4/6 inhibitor (i) setting (ESMO 2026) - No abstract available

Biomarker • Metastases • P3 data • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2

PTBP1-Mediated Alternative Splicing of DNAJB6 Promotes Everolimus Resistance in Clear Cell Renal Cell Carcinoma via EIF4B/PKIB/AKT/mTOR Positive Feedback Loop. (PubMed, Adv Sci (Weinh)) - "This study demonstrates that PTBP1 drives EVE resistance in ccRCC by upregulating DNAJB6b, which recruits EIF4B to initiate a PKIB/AKT/mTOR positive feedback loop, sustaining oncogenic translation and therapeutic evasion."

Journal • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor • PTBP1

OUTCOMES OF EVEROLIMUS-BASED IMMUNOSUPPRESSION AFTER LIVER TRANSPLANTATION FOR HEPATOCELLULAR CARCINOMA WITH OR WITHOUT STEROID INDUCTION (UEGW 2026) - "Patients at ISMETT received steroid-free induction with basiliximab, while Bergamo patients received steroid induction. Everolimus-based immunosuppression is safe after LT for HCC, even within steroid-free induction protocols. However, everolimus monotherapy may increase the risk of ACR. CNI-minimization strategies appear feasible when carefully selected and monitored."

Fibrosis • Hepatocellular Cancer • Hepatology • Immunology • Oncology • Solid Tumor • Transplantation

LATE-ONSET GRAFT-VERSUS-HOST DISEASE FOLLOWING DECEASED DONOR LIVER TRANSPLANTATION IN AN ADOLESCENT: A MISSED DIAGNOSIS WITH FATAL OUTCOME (UEGW 2026) - "Clinical Case Summary: Clinical Case Summary: A 16-year-old Sri Lankan female with advanced chronic liver disease from autoimmune hepatitis underwent ABO-compatible deceased donor liver transplantation (DDLT) (February 2025; CTP class B, MELD 16) and was on tacrolimus, mycophenolate mofetil, and prednisolone.Post-transplant course was marked by recurrent T-CmACR at months one and two, treated with methylprednisolone pulses and escalating immunosuppression. Acute kidney injury (AKI) (creatinine 154 µmol/L; tacrolimus 15.1 ng/mL), prompted substitution of tacrolimus with cyclosporine and addition of everolimus...The patient died in February 2026. GVHD at nine months post-DDLT is well outside the classical two-to-eight-week window, a late presentation rarely documented in solid organ transplantation.Repeated immunosuppressive escalation for recurrent T-CmACR likely eroded recipient immune surveillance, permitting unchecked donor lymphocyte expansion, a mechanism..."

Acute Kidney Injury • Autoimmune Hepatitis • Graft versus Host Disease • Hematological Disorders • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Failure • Metabolic Disorders • Nephrology • Septic Shock • Solid Organ Transplantation • Transplantation

WHEN CROHN'S DISEASE WAS NOT THE ONLY DIAGNOSIS: ILEAL KAPOSI SARCOMA IN A TRANSPLANT RECIPIENT PRESENTING WITH SUBOCCLUSIVE SYMPTOMS (UEGW 2026) - "We report the case of a 69-year-old kidney transplant recipient on long-term immunosuppression with everolimus, tacrolimus, and prednisone, who presented with recurrent abdominal pain, diarrhea, fever, and subocclusive symptoms. It also illustrates that surgery may be both diagnostic and therapeutic, allowing complete resection of an occult KS lesion while resolving mechanical obstruction. A timeline of the clinical course will be provided in the poster to clearly display the sequence of symptoms, investigations, surgery, pathology, and follow-up."

Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Kaposi Sarcoma • Sarcoma • Solid Tumor • Transplantation • Ulcerative Colitis

hiPSC-derived Cortical Organoid Platform to Screen Treatments for Tuberous Sclerosis Complex (Neuroscience 2026) - "mTORC1 inhibitors, such as everolimus, are approved treatments for TSC...Together, these results show that TSC seizure-like hyperactivity can be reliably recapitulated in both 2D NGN2 or glutamatergic neuron co-culture and 3D hCO models. In the future, transitioning to high-throughput 3D calcium imaging combined with HD-MEA hit validation may be a viable tool to screen cortical organoids for treatments to reduce seizure burden in TSC patients."

CNS Disorders • Epilepsy • Mental Retardation • NEUROG2 • TSC1 • TSC2

Comparative Effects of Pairwise Combinations of Carboplatin, Everolimus, and Astaxanthin on Cell Viability, Migration, and Inflammatory Biomarkers in SKOV3 Ovarian Cancer Cells. (PubMed, Int J Mol Sci) - "These observations represent preliminary comparative in vitro effects rather than evidence of pharmacological synergy or therapeutic benefit. Further mechanistic studies using additional ovarian cancer cell lines, formal drug interaction analyses, and in vivo models are required to establish the biological and potential therapeutic relevance of these treatment combinations."

Biomarker • Clinical • Journal • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • IL1B • TNFA

Long-Term Monitoring of Everolimus Concentrations in Routine Clinical Practice: Evaluation of Patient Percentiles as Quality Indicator and Impact of Analytical Method Change. (PubMed, Pharmaceuticals (Basel)) - " Everolimus concentration distributions were stable over time and showed no meaningful sex-related or seasonal variation. Patient percentile monitoring detected a clear analytical shift after method implementation and may serve as a practical supplementary quality indicator for TDM assays."

Journal • Oncology • Transplantation

A multicenter phase II trial of everolimus for unresectable pancreatic neuroendocrine carcinoma refractory or intolerant to platinum-based regimen (clinicaltrials.gov) - P2 | N=25 | Completed | Sponsor: National Cancer Center Hospital East | Unknown status ➔ Completed

Trial completion • Endocrine Cancer • Gastrointestinal Neuroendocrine Carcinoma • Neuroendocrine Carcinoma • Oncology • Solid Tumor

Gastrointestinal and Renal Adverse Events following Kidney SBRT for Renal Cell Carcinoma: Impact of Recent Systemic Therapy Use (ASTRO 2026) - "Recent systemic therapy was defined as RCC-directed agent within 6 months pre- or 12 months post-SBRT, classified as multitarget tyrosine kinase inhibitors (TKIs), immune checkpoint inhibitors (ICIs), or other (everolimus, belzutifan, bevacizumab)...TKIs included cabozantinib (n=11), axitinib (n=9), lenvatinib (n=8), and tivozanib (n=1)... BP rates were higher among kidney SBRT patients treated with recent combination TKI+ICI therapy. Given the retrospective design and limited sample size, results should be interpreted cautiously."

Adverse events • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Trends In Industry-Sponsored Research Payments to Radiation Oncology Principal Investigators (ASTRO 2026) - "The top products associated with ISRPs to radiation oncologists were pembrolizumab ($80.3M, Merck), durvalumab ($31.8M, AstraZeneca), everolimus ($16.1M, Novartis), canakinumab ($9.3M, Novartis), and Lu-177 ($8.8M, Novartis). Overall ISRPs to radiation oncologists increased between 2015-2023 with increasing allocation to NCEs. Most payments were associated with a small number of products and manufacturers. Understanding industry payment trends and practices is critical as a supplement and alternative to federal funding, particularly given uncertainty in future federal research support."

Oncology

177Lu-edotreotide Absorbed Dose In Patients with Gastroenteropancreatic Neuroendocrine Tumors: Dosimetry Results from Compete (ASTRO 2026) - P3 | "Purpose/Objective(s): In the Phase 3 COMPETE trial, patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) were randomized to receive 177Lu-edotreotide 7.5 ± 0.7 GBq every 3 months (maximum 4 cycles) or everolimus 10 mg daily (NCT03049189). Kidney ADCs remained constant over time with low intra-patient variability, which allows for estimating individual radiation burden based on cycle 1 dosimetry data. The tumor ADC decreased over time, but the tumor-to-kidney ADC ratio remained positive across cycles. Future research will explore the relationship between absorbed dose and treatment response."

Clinical • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Oncology • Renal Cell Carcinoma • Solid Tumor

Breast cancer-associated fibroblast-derived exosomal miR-1290 promotes triple-negative breast cancer cell proliferation. (PubMed, Signal Transduct Target Ther) - "Furthermore, we demonstrated that treatment with the mTOR inhibitor rapamycin and the FDA-approved rapamycin analog everolimus effectively suppressed miR-1290-induced TNBC cell proliferation, suggesting a potential therapeutic strategy for TNBC. Moreover, in patient cohorts, elevated levels of circulating miR-1290 significantly distinguished patients with breast cancer from healthy individuals and correlated with poor survival outcomes. Therefore, miR-1290 and its direct target TBC1D4 have potential value in both targeted treatment and diagnosis of TNBC."

Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CAFs • MIR1290 • TSC1

An Unusual Presentation of Small Bowel Obstruction Following Liver Transplantation (ACG 2026) - "Complications include persistent ascites, treated with furosemide; acute kidney injury; and urinary retention...The patient receives a standard immunosuppressive regimen of tacrolimus following discontinuation of everolimus due to side effects...Nirogacestat, a ɣ-secretase inhibitor, targets aberrant Notch signaling in tumor proliferation. Radiation may offer a non-surgical alternative. Furthermore, an intestinal or multivisceral transplant may be considered, particularly when removal of desmoid tumors leads to short bowel syndrome."

Acute Kidney Injury • Desmoid Tumors • Fibrosis • Gastrointestinal Disorder • Hepatology • Immunology • Nephrology • Renal Disease • Sarcoma • Short Bowel Syndrome • Solid Tumor • Transplantation • CCND1 • NOTCH1

Pseudomelanosis Duodeni in a Renal Transplant Recipient: An Unusual Endoscopic-Pathologic Correlation With Extreme Iron Discordance (ACG 2026) - "Mycophenolate was held; everolimus and prednisone were continued. Figure: Endoscopic view of the duodenal bulb demonstrating diffuse punctate, speckled black pigmentation (âpepperedâ appearance) consistent with iron sequestration in pseudomelanosis duodeni. Figure: H&E stained image on the left showing duodenal villi with hemosiderin-laden macrophages in the lamina propria; image on the right with iron special (Prussian blue) stain highlighting iron deposition."

Clinical • Discordant • Acute Kidney Injury • Atrial Fibrillation • Bipolar Disorder • Cardiovascular • Chronic Kidney Disease • CNS Disorders • Diabetes • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hypertension • Metabolic Disorders • Nephrology • Pulmonary Disease • Renal Disease • Respiratory Diseases • Transplantation • Type 2 Diabetes Mellitus

Chronic Graft-Versus-Host Disease Following Intestine, Liver, Pancreas, and Stomach Transplantation (ACG 2026) - "Therapy escalates from everolimus and octreotide to capecitabine and temozolomide, with subsequent disease progression...Dermatology and hematology are consulted, topical steroids are started for the rash and tbo-filgrastim for worsening neutropenia...After refusing cytogam, he returns with rising CMV levels, is treated with IV ganciclovir, and discharged with oral valganciclovir...Persistent donor predominance on STR analysis with cutaneous and bone marrow involvement is shown. Treatment includes corticosteroids, etanercept, photopheresis, ruxolitinib, and supportive care."

Acute Graft versus Host Disease • Cardiovascular • Chronic Graft versus Host Disease • Cytomegalovirus Infection • Gastrointestinal Neuroendocrine Tumor • Graft versus Host Disease • Hematological Disorders • Hepatology • Immunology • Infectious Disease • Leukopenia • Neuroendocrine Tumor • Neutropenia • Pulmonary Disease • Respiratory Diseases • Solid Organ Transplantation • Solid Tumor • Transplantation

Multifactorial Encephalopathy: A Challenging Case of Tacrolimus Toxicity, Posterior Reversible Encephalopathy Syndrome (PRES), and Steroid Delirium in a Post-Transplant Patient (ACG 2026) - "An MRI was performed revealing PRES, as a result cyclosporine was discontinued and he was maintained on weekly basiliximab, prednisone and mycophenolate...Four weeks post transplant, he was initiated on everolimus with improvement in liver enzymes and he was discharged with full neurologic recovery...While tacrolimus is typically considered more likely to pose neurotoxic side effects than cyclosporine, patients with malnutrition may be at significant risk of cyclosporine induced toxicity. Calcineurin inhibitors are the cornerstone of therapy post-transplant; however, this paradigm must be challenged in cases of PRES refractory to first line measures."

Clinical • Post-transplantation • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Inflammatory Bowel Disease • Insomnia • Primary Sclerosing Cholangitis • Sleep Disorder • Transplantation • Ulcerative Colitis

Hepatitis E Virus Genotype 3: An Under-Recognized Mimic of Cellular Rejection in a North American Liver Transplant Patient (ACG 2026) - "He was maintained on everolimus with stable trough levels...Ribavirin was initiated at 400 mg daily and titrated to 600 mg...Given that 60â70% of OLT recipients with HEV progress to chronicity and accelerated allograft cirrhosis, early diagnosis via HEV RNA PCR is essential. HEV must be excluded before escalating immunosuppression for suspected ACR, as intensified immunosuppression risks worsening viral replication and fibrotic progression."

Clinical • Fibrosis • Hepatology • Immunology • Infectious Disease • Inflammation • Solid Organ Transplantation • Transplantation