everolimus (SVG101) / SoVarGen - LARVOL DELTA

🎥 @brian_rini & @PBarataMD discuss #LITESPARK-005: 🌟 Belzutifan vs. Everolimus in refractory ccRCC: ✅ PFS & response rates favor belzutifan. ❌ No OS benefit yet. 📋 Discussion highlights: Managing anemia & hypoxia with belzutifan. Subset of patients show prolonged benefit—ongoing biomarker research. Future of HIF inhibitors in kidney cancer therapy. #FullVideo on UroToday >...

Development of Mtor-targeting Antisense Oligonucleotides for Treating Mtoropathies with Intractable Focal Epilepsy (AES 2024) - "mTOR-targeting ASOs significantly reduce seizure activity in model mice, have long-lasting effects, and lower the risk of adverse events compared to everolimus. The intrathecal delivery of MTOR-targeting ASOs could offer a safer and more effective treatment for epilepsy in mTORopathies, showing promise as a novel therapeutic approach."

CNS Disorders • Epilepsy • Infectious Disease

ESMO 2024 Kidney Cancer Highlights (Kidney Cancer) - '"At the final analysis of the phase 3 LITESPARK-005 study, belzutifan continued to show PFS and ORR benefits vs everolimus, including durable responses lasting over 2 years,' said lead researcher Dr. Brian Rini...'With over 2 years of minimum follow-up, more participants remained on treatment with belzutifan vs everolimus, [but] significant improvement in OS was not observed.'"

Media quote • Renal Cell Carcinoma

Belzutifan vs Everolimus Trial Data in Advanced RCC Care - Brian Rini (UroToday) - "Brian Rini...discuss the updated results of the Phase 3 LITESPARK-005 trial. The study, which led to belzutifan's approval in December 2023, compares belzutifan to everolimus in refractory clear cell RCC patients who previously received PD-1/PD-L1 and VEGF-TKI therapy."

Video

LENVIMA (lenvatinib) + everolimus, featuring Dr. Thomas Hutson (YouTube) - "LENVIMA (lenvatinib) is indicated, in combination with everolimus, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy."

Video

Efficacy and safety of everolimus for patients with focal cortical dysplasia type 2. (PubMed, Epilepsia Open) - P2 | "This study tested everolimus for reducing seizures in patients with focal cortical dysplasia type 2 (FCD 2). While the drug was not more effective than a placebo for most, few patients showed better results, with some becoming seizure-free. Side effects were common but manageable. More research is needed to understand why certain patients respond better to treatment."

Clinical • Journal • CNS Disorders • Epilepsy • Mucositis • mTOR

Pharmac Considers Funding for Lenvatinib & Requests Bevacizumab Tenders (NAVLIN DAILY) - "New Zealand’s Pharmac is consulting on a proposal to fund lenvatinib. If approved, the funding would begin on December 1, 2024. Specifically, the group is seeking feedback on the following proposals: Fund lenvatinib for kidney, thyroid and liver cancer from 1 December 2024. Widen access to everolimus for kidney cancer (in combination with lenvatinib) from 1 December 2024. In parallel, PHARMAC has issued a request for tender (RFT) to secure the supply of bevacizumab, with an aim to make it available by April 2025, or sooner, depending on the outcome of the tender process...Funding applications for bevacizumab for a number of different cancer types are currently under assessment or ranked on Pharmac’s options for investment list."

Reimbursement • Hepatocellular Cancer • Kidney Cancer • Liver Cancer • Oncology • Solid Tumor • Thoracic Cancer

GI Cancer ESMO 2023 Highlights : Episode 2: CABINET: Cabozantinib Versus Placebo in Patients With Advanced Neuroendocrine Tumors After Progression on Everolimus (Targeted Oncology) - "Expert medical oncologists review data from the CABINET trial evaluating cabozantinib compared with placebo in two cohorts of previously treated patients with neuroendocrine tumors."

Video

Uromigos Live 2023 Kidney: Belzutifan Versus Everolimus, Combinations in Refractory Disease (YouTube) - "In the third part of The Uromigos Live 2023 kidney cancer panel 1, Drs. Thomas Powles, Brian Rini, Tian Zhang, Sumanta Pal, and Toni Choueiri compare the survival curves of belzutifan and everolimus, and then weigh the data related to belzutifan plus cabozantinib as well as belzutifan plus lenvatinib in IO-refractory RCC. They conclude with considerations for belzutifan's most likely home in the treatment paradigm in the near future."

Video • Renal Cell Carcinoma

ESMO23: Toni Choueiri, MD LITESPARK-005 | Dana-Farber Cancer Institute (YouTube) - "Kidney cancer research presented at ESMO23. 'This is real progress for patients,' said...Toni Choueiri, MD. In this video, he details the LITESPARK-005 study that showed cancer progression in patients with advanced disease was reduced by 25-26% with belzutifan compared to everolimus."

Video

The Role of Somatostatin Analogue Maintenance Therapy in Refractory Metastatic Neuroendocrine Tumors (NETs): Comparative Analysis (NANETS 2023) - P=NA | N=4,319 | "Addition of maintenance SSAs to targeted therapies was not associated with significant benefit in tumor control in patients with refractory metastatic NETs. These results need to be validated in prospective randomized controlled trials designed to include both survival benefit and associated financial toxicity."

Clinical data

Renal Cell Carcinoma Treatment Updates from ASCO 2023 and KCRS 2023 : Episode 9: RCC Histologies: Clear Cell vs Non–Clear Cell (Targeted Oncology) - "Clinical insights from a leader in kidney cancer research on the differences between clear cell and non–clear cell renal cell carcinoma."

Video • Renal Cell Carcinoma

What's New in the Field of Neoadjuvant Therapy and Renal Cell Carcinoma? (Medscape) - "Pal: Today we're going to start off by talking about something we always talk about right at the outset of these programs, which is what got you into kidney cancer. It's a narrow field, and I have to say that it's sometimes an off-the-beaten-path choice for doctors. How did you find yourself leaning toward RCC?"

Audio • Renal Cell Carcinoma

Adjuvant Everolimus in Patients With Renal Cell Carcinoma at High Risk of Recurrence (THE ASCO POST) - "In the phase III EVEREST trial reported in The Lancet, Christopher W. Ryan, MD, and colleagues found that adjuvant everolimus was not associated with a significant improvement in event-free survival vs placebo in patients at high risk of disease recurrence following surgery for renal cell carcinoma."

Dr Rana McKay on First-line Therapies for Metastatic Renal Cell Carcinoma (AJMC) - "Renal cell carcinoma (RCC), or kidney cancer, is among the most common cancers in the United States, affecting men more than women. In this first part of a 2-part series, Rana R. McKay, MD...provides an overview of the treatment landscape for advanced RCC....McKay: VEGF TKIs are now largely utilized in combination with frontline immunotherapy options. Following progression on frontline IO, largely single-agent VEGF inhibition is utilized in the salvage setting. In the TKI era, nivolumab was tested post-VEGF progression in a trial comparing nivolumab to everolimus and that was the first approval of a checkpoint inhibitor in renal cell carcinoma. However, that data is largely not relevant in the modern era, because we are largely utilizing IO combinations in the front line."

Media quote

Harnessing the Potential of Immunotherapy, Optimal Sequencing in Advanced RCC - "GU Oncology Now spoke with David Braun, MD, PhD...regarding currently available later-line therapy options for patients with advanced renal cell carcinoma (RCC), how the therapies are sequenced, and the 'buckets' of treatment options most worthy of further research."

Media quote • Renal Cell Carcinoma • Von Hippel-Lindau Syndrome

Sequencing for Metastatic Clear Cell Renal Cell Carcinoma After Prior Therapy : Episode 12 Hammers and Participants Discuss AEs Associated with TKIs in RCC (Targeted Oncology) - "Hans Hammers, MD, PhD: Frequent use of this type of regimen [would fit into the] second- and third-line space. But [many physicians will use] cabozantinib [Cabometyx] first, and then lenvatinib plus everolimus. If you start at the higher dose, you tend to have more benefit that you may not necessarily make up. However, it is difficult to apply it to everyone when we individualize [treatment for patients]."

Media quote

Cytoreductive nephrectomy helped control Paul Laudadio’s metastatic kidney cancer (Kidney Cancer Association) - "Jonasch, his medical oncologist, said that it is rare for patients to be long-term responders to everolimus. 'I have had a few patients in addition to...who have enjoyed similar magnitude of benefit from this agent,' he said. 'Certain tumor mutations, particularly in the P13K pathway, portend for a better outcome on everolimus.' Today, oncologists more typically use everolimus in combination with lenvatinib, another targeted therapy, than alone, Jonasch noted."

Media quote

The Evolving Advanced RCC Treatment Landscape (OncLive) - "Researcher and clinician, Dr. Thomas Hutson reflects on the modern patient journey and shares his experience treating people with advanced RCC. Through the years, the advanced RCC treatment landscape has evolved significantly. In this two-part series brought to you by Eisai Inc., hear from oncologist Thomas Hutson, DO as he reflects on best practices for evaluating today's treatment options."

Online posting

Dr. Hahn on the Investigation of Lenvatinib/Everolimus Vs Cabozantinib in mRCC (OncLive) - "Andrew W. Hahn, MD, discusses the investigation of lenvatinib plus everolimus vs cabozantinib in metastatic renal cell carcinoma following progression on an immune checkpoint inhibitor."

Video

A 71-Year-Old Woman with Relapsed-Refractory (R/R) Metastatic Clear Cell Renal Cell Carcinoma : Episode 4: Utilizing Lenvatinib Plus Everolimus in the Metastatic Renal Cell Carcinoma Setting (Targeted Oncology) - "A closer look at lenvatinib plus everolimus in patients with advanced renal cell carcinoma, touching on dose-related toxicities."

Video • Renal Cell Carcinoma

Post-second-line systemic treatment for advanced RCC (YouTube) - "Tian Zhang, MD...comments on post-second-line systemic treatment for advanced renal cell carcinoma, including with axitinib, everolimus, cabozantinib and tivozanib. Nivolumab is approved in refractory settings."

Video • Renal Cell Carcinoma

Investigational Treatments for Refractory RCC Expand Beyond Immunotherapy (OncLive) - "Brian I. Rini, MD, discusses standard and investigational treatment options for patients with RCC who are refractory to immunotherapy; the potential role of biomarkers in future targeted treatments; and the need for novel mechanisms such as HIF inhibition to meet the needs of patients who don't respond to immunotherapy or VEGF TKIs."

Media quote

The Role of Everolimus in the Adjuvant Setting for Patients with Renal Cell Carcinoma: EVEREST (SWOG S0931) - Christopher Ryan (Urotoday) - "...Christopher Ryan to discuss SWOG S0931, the EVEREST trial of everolimus as adjuvant therapy for patients with renal cell carcinoma (RCC)....Dr. Ryan concluded that, in the EVEREST trial, while adjuvant everolimus improved RFS in patients with RCC after nephrectomy, it failed to me the pre-specified statistical threshold for significance."

Video

Second-Line Treatment of Renal Cell Carcinoma (Medscape) - "Pal: Absolutely. You're probably well known to this audience, but if you could just give us a little bit of background...I'm particularly curious about how you got into the field of kidney cancer specifically."

Audio • Renal Cell Carcinoma