Read the Full Video Transcript
Pedro Barata: Hello and welcome. My name is Pedro Barata. I'm a GU medical oncologist and an associate professor of medicine at Tulane Medical School in New Orleans, Louisiana. It's my true pleasure to be joined today by Dr. Laurence Albiges. She's really well-known and a star in the kidney clinical arena. She's an MD/PhD medical oncologist, and currently the head of the Medical Oncology Department at Gustave Roussy in Villejuif, France. So welcome, Dr. Albiges. Thank you so much for taking the time to be with us today.
Laurence Albiges: Thank you, Pedro. Thank you for the invitation.
Pedro Barata: Absolutely. By the way, I start by congratulating you for your fantastic talk and presentation of a very important study, your phase 2 Keynote-B61 that basically explore the combination of lenvatinib with pembrolizumab as first-line treatment for patients with non-clear cell renal cell carcinoma. So again, very elegant presentation, and I was hoping we could talk a little bit about that today if that's okay with you.
Laurence Albiges: Sure. That will be my pleasure. So actually, this is a phase 2 in an area that is clearly an unmet need. Namely, what we call non-clear cell renal cell carcinoma that should not be named as such because these are different entities that are usually having a worse prognosis than clear cell, and that are really challenging to treat. And so what we've been reporting this time, and it's the first time we're presenting the data, is a phase 2, a non-randomized phase 2, that enroll patient with non-clear cell histology that never been previously treated and that were treated with a combination of pembrolizumab administered every six weeks with lenvatinib at 20 milligrams per day. So it's a combination of VEGF TKI, lenvatinib, plus immune checkpoint pembrolizumab. The primary endpoint of this study is response rate.
Pedro Barata: Fantastic. Thank you so much. And so remind us, as you were saying, which you raise a very, very good point, right? Non-clear cell behaves differently from clear cell. And we can actually go further and argue that actually within non-clear cell group, there's many different diseases that are part of these broad classification of non-clear cell. Can you remind us what type of patients were enrolled in these phase two, as far as histology goes, and then go ahead also and give us kind of the highlights, if you will, on the efficacy portion of this study.
Laurence Albiges: Sure. So that study is about a 150-patient study. What has been presented at this ESMO are the very first results with an efficacy population of 82 patient. These were patient for which we had sufficient follow-up. And with regard to your question of histology, the vast majority of those patients are papillary nccRCC carcinoma. They account for 51 patient in the efficacy population. So that's about 62% of patient. The second most frequent entity are what we call chromophobia RCC, and we know those patients are hard to treat because they tend to be less sensitive or less responding to an immune checkpoint when used as single agent. And then we had other histologies, such as translocation RCC or unclassified tumors, or even more rare tumors, such as medullary carcinoma. So these are, as you can see, a very [inaudible] patient population.
Laurence Albiges: What are the key results? Well, first, the response rate, that is achieving 47.6%. So almost one patient out of two that has objective response. The disease control rate, that is 79%. So basically, almost 80% of patient that has either partial response or stable disease or even complete response. And if you look at the response by histology [inaudible], it's very consistent across papillary and classified translocation and other tumor type. The histology where we saw the less responsive were it chromophobe tumor, as anticipated. And I think, at this point, it's important to stress that we already had data with pembrolizumab single agents that were previously reported by David McDermot. We had seen other regimen with combination with VEGF TKI, and this is the first report of lenvatinib, plus pembrolizumab in this histology of patient with non-clear cell. There was no significant signal in terms of safety. This is the regimen that we are used to handle.
Laurence Albiges: And so, therefore, there was no new safety signal. I think it's important that out of the 82 patient that were accessible for response, we could see some degree of tumor shrinkage in the vast majority of them. It was 86% of patient that had some degree of tumor shrinkage. So clearly, a combination that is active, for now, the follow-up is short. We only had 8.2 months follow-up. Nevertheless, many patients were still under treatment at the time of analysis. Therefore, we will be waiting for further follow-up and the entire patient population to be followed, to provide final analysis.
Pedro Barata: No, it is so important as you mentioned and summarized these results. It's very good news, in my opinion, promising results for patients with non-clear cell histologies. And so thank you for highlighting it so elegantly for us. And as you mentioned, so now we have data with lenvatinib, pembrolizumab. There are other combos being explored out there with proof of concept and promising results. So can you tell us what the next steps for these efforts seem to be? I mean, sounds like you're going to update with longer, with more mature follow-up, you're going to update those results and hopefully we'll see the data being consistent over time. Is any other perspectives you can share with the audience as far as next steps for the non-clear cell RCC patients?
Laurence Albiges: Yeah. Thank you. So what I'm not yet able to provide you with is the progression-free survival, given that for now, median follow-up is at 8.2 months. What we have at six months is 72.3% of patient that are progression-free at that step. So we haven't yet reached the median PFS. And of course, we don't have yet the overall survival for this patient population. I think these items are very important. As we said, these patients tend to have a poor prognostic. And so, therefore, being able to generate prospective data of combination regimen in this space is very important. So we are eagerly waiting for those longer-term follow-up to define the potential role of this combination in patient with non-clear cell.
Pedro Barata: That's fantastic. Well, Dr. Albiges, I feel like we could stay and talk about this much longer. I really appreciate your taking the time to talk to us. Again, congratulations. Very elegant presentation and I'm looking forward to actually follow-up data and also the publication, right? So again, thank you and congratulations.
Laurence Albiges: Thank you very much.
- Cell-Based Regenerative Medicine Market Size to Witness Rapid Growth at a CAGR of 15% by 2032 | insightSLICE - EIN News - May 9th, 2023
- Indian Pharma Congress: Gene-cell therapy, preventive medicine future of health care, says expert - Economic Times - January 21st, 2023
- Cell culture - Wikipedia - December 18th, 2022
- The Legacy of Henrietta Lacks - Hopkins Medicine - December 10th, 2022
- HOME | Stem cell & Cancer - October 4th, 2022
- CAR T Cell Therapy Offers a New Hope in the Treatment of Severe and Refractory Systemic Lupus Erythematosus - Rheumatology Network - October 4th, 2022
- Cell and Gene Therapy: Rewriting the Future of Medicine - Technology Networks - October 4th, 2022
- Outlook on the Automated Cell Counters Global Market to 2028 - Use of Cell Counters in Personalized Medicine Presents Opportunities -... - October 4th, 2022
- Jcr Pharmaceuticals Co., Ltd. and Sysmex Establish A Joint Venture in the Field of Regenerative Medicine and Cell Therapy - Marketscreener.com - October 4th, 2022
- Growth in Cell and Gene Therapy Market - BioPharm International - October 4th, 2022
- Breakthrough in production of cancer-treating drug - Stanford University News - October 4th, 2022
- CRISPR Therapeutics Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to CTX130 for the Treatment of Cutaneous T-Cell... - October 4th, 2022
- Mary Munson elected fellow of the American Society for Cell Biology - UMass Medical School - October 4th, 2022
- 5 FDA decisions to watch in the fourth quarter - BioPharma Dive - October 4th, 2022
- bit.bio Adds Two New Human Cell Products to Address the Translation Gap and Accelerate Research and Drug Discovery for Neurodegenerative Disease -... - October 4th, 2022
- Laser Focus World highlights UC research that uses light to restore cell function - University of Cincinnati - October 4th, 2022
- The Institute of Regenerative Medicine | Non-Surgical, Cell-Based ... - September 25th, 2022
- CAR T-Cell Therapy Shows Promise in Treating Lupus - Healthline - September 25th, 2022
- ProKidney to Present at the Jefferies Cell and Genetic Medicine Summit - El Paso Inc. - September 25th, 2022
- Allogene Therapeutics Announces Participation in the Jefferies Cell and Genetic Medicine Summit - GlobeNewswire - September 25th, 2022
- Alzheimer's disease risk linked to newly discovered protein mutation - Medical News Today - September 25th, 2022
- Biological Links Identified Between an Aggressive Breast Cancer Type and African Ancestry - Weill Cornell Medicine Newsroom - September 25th, 2022
- The Use of Nanorobotics in the Treatment Therapy of Cancer and Its Future Aspects: A Review - Cureus - September 25th, 2022
- UW Health, UW-Madison School of Medicine and Public Health: Innovative clinical trial targets recurrent BK infection in kidney transplant recipients -... - September 25th, 2022
- Shutting down backup genes leads to cancer remission in mice - University of Michigan News - September 25th, 2022
- FDA's ODAC Votes That Benefits Do Not Outweigh Risks for Poziotinib in HER Exon 20 Ins+ NSCLC - Targeted Oncology - September 25th, 2022
- Courageous Lanarkshire teen who survived leukaemia thanks to a clinical trial pursues nursing dream - Daily Record - September 25th, 2022
- Discovery Reveals How the Immune System Tolerates Friendly Gut Bacteria - Weill Cornell Medicine Newsroom - September 8th, 2022
- Study: New Factors Are Associated With Increased PFS from BCMA-Targeted T-Cell Therapy - Pharmacy Times - September 8th, 2022
- Study Uncovers Possible Path for Improving T Cell Therapies - University of Arizona - September 8th, 2022
- Trodelvy Significantly Improved Overall Survival in Pre-Treated HR+/HER2- Metastatic Breast Cancer Patients in TROPiCS-02 Study - Gilead Sciences - September 8th, 2022
- Manipulating Astrocytes in Tumor Environment Effective Against Glioblastoma - Inside Precision Medicine - September 8th, 2022
- Jane Fonda Diagnosed with Non-Hodgkin's Lymphoma: What to Know - Healthline - September 8th, 2022
- Dr Hatim Husain: Biomarker Testing Is a Treatment Cornerstone in NSCLC - AJMC.com Managed Markets Network - August 30th, 2022
- Porton Advanced and Kun Tuo Announce Strategic Partnership to Deepen Gene and Cell Therapy CDMO and Clinical Research Services - PR Newswire - August 30th, 2022
- The Role of Eosinophils as a Biomarker to Inform Treatment Decisions for Patients With COPD - Consultant360 - August 30th, 2022
- Scientists Discover Surprise Anticancer Properties of Common Lab Molecule | Newsroom - UNC Health and UNC School of Medicine - August 30th, 2022
- Overall survival is similar for patients receiving CT-based or minimal follow-up after surgical resection of non-small-cell lung cancer - 2 Minute... - August 30th, 2022
- NSF Grant to Aid OSU Researchers Developing Treatment for Canine Cancer - The Corvallis Advocate - August 30th, 2022
- Researchers Identify the Target of Immune Attacks on Liver Cells in Metabolic Disorders - Weill Cornell Medicine Newsroom - August 22nd, 2022
- Why Is CAR T-Cell Therapy One of the Most Phenomenal Advances in Science? - University of Colorado Anschutz Medical Campus - August 22nd, 2022
- Porton Advanced Solutions completes a Series B financing round to expand its end-to-end Gene and Cell Therapy CDMO Platforms - PR Newswire - August 22nd, 2022
- Cell Analysis Global Market Report 2022: Growing Focus on Personalized Medicine & Introduction of Advanced Technologies in Cell Analysis Presents... - August 22nd, 2022
- Stress can throw off circadian rhythms and lead to weight gain - Medical News Today - August 22nd, 2022
- Cell Stress and Mitochondrial Dysfunction Found in Early Alzheimers Disease Patients, Findings Published in Science Translational Medicine - BioSpace - August 22nd, 2022
- Restoring cell and organ function after the heart stops - National Institutes of Health (.gov) - August 22nd, 2022
- Rolling the Dice: Gamble Pays Off For Cancer Patient in CAR T-Cell Clinical Trial - University of Colorado Anschutz Medical Campus - August 22nd, 2022
- Boosting neuron formation restores memory in mice with Alzheimer's disease - EurekAlert - August 22nd, 2022
- UTSW study finds p53 gene plays second role in suppressing genes tied to cancer - UT Southwestern - August 22nd, 2022
- GlyNAC supplementation reverses mitochondrial dysfunction, oxidative stress and aging hallmarks to boost strength and promote health in aging humans -... - August 22nd, 2022
- Multiple shots of the BCG vaccine protect type 1 diabetics from COVID-19 - EurekAlert - August 22nd, 2022
- Cell Regeneration Medicine Market Analysis by Type, Application, Growth, Demand, Status, and Forecast from 2022 to 2032 - Digital Journal - August 5th, 2022
- Higher Hydroxyurea Exposure Tied to Better Blood Parameters in US... - Sickle Cell Anemia News - August 5th, 2022
- Kiwis with multiple sclerosis patients thriving from overseas stem-cell treatment urge Government to approve it here - Newshub - July 27th, 2022
- MHRA grants marketing authorisation to Global Blood Therapeutics for sickle cell disease drug - PMLiVE - July 27th, 2022
- CAR T-Cell Therapy Turns 10 and Finally Earns the Word 'Cure' - Medscape - July 27th, 2022
- Oncology Peer Review On-The-Go: The Prognostic Significance of Peripheral Blood Biomarkers in Patients With Advanced NonSmall Cell Lung Cancer Treated... - July 27th, 2022
- CRISPR therapeutics can damage the genome - EurekAlert - July 27th, 2022
- To cell surface and beyond: Tracing subcellular glycoprotein transport using modified cholera toxin - EurekAlert - July 27th, 2022
- From Donor to Patient: Advancing the Future of Cell Therapies - Genetic Engineering & Biotechnology News - July 27th, 2022
- Five-Year Review of Biomedical Research Imaging Center, Center Director | Newsroom - UNC Health and UNC School of Medicine - July 27th, 2022
- Using Particles That Are Smaller Than the Head of a Pin to Treat Cancer - Yale School of Medicine - July 11th, 2022
- Stem Cell Assays Market Report 2022-2027: Increasing Awareness About Therapeutic Potency of Stem Cells Driving Growth - ResearchAndMarkets.com -... - July 11th, 2022
- Sickle cell disease could be treated with common plant, study finds - The Telegraph - July 11th, 2022
- Unexpected link between most common cancer drivers may yield more effective drugs - University of Wisconsin-Madison - July 11th, 2022
- Scientists Discover Key to Hepatitis A Virus Replication, Show Drug Effectiveness | Newsroom - UNC Health and UNC School of Medicine - July 11th, 2022
- How Erectile Dysfunction Drugs Can Help Treat Cancer and Save Thousands of Lives - SciTechDaily - July 11th, 2022
- Pune: Dr Mohan Wani appointed as director of National Centre for Cell Science - The Indian Express - July 11th, 2022
- Kite's CAR T-cell Therapy Yescarta Granted European Marketing Authorization for the Treatment of Relapsed or Refractory Follicular Lymphoma - Gilead... - July 3rd, 2022
- Important Factors for Regulating the Body's Immune Response - Neuroscience News - July 3rd, 2022
- Stem Cell Therapy Market Is Expected To Reach USD 455.61 Billion By 2027 At A CAGR Of 16 percent By Forecast 2027 Says Maximize Market Research (MMR)... - July 3rd, 2022
- Neurona Therapeutics Announces Initial Subject Dosed in First Clinical Trial of Regenerative Human Cell Therapy, NRTX-1001, in Adults with... - July 3rd, 2022
- Growing scope of Genetic Medicine and Stem Cell Research - The Hindu - June 22nd, 2022
- When children with sickle cell grow up, they face a system not designed for them - 89.3 WFPL News Louisville - June 22nd, 2022
- Precision BioSciences Announces In Vivo Gene Editing Collaboration with Novartis to Develop Potentially Curative Treatment for Disorders Including... - June 22nd, 2022
- Stem Cell Assays Market worth $4.5 billion by 2027 - Exclusive Report by MarketsandMarkets - PR Newswire - June 22nd, 2022
- Bringing heart and humanity to hematology | News | Harvard TH Chan School of Public Health - HSPH News - June 22nd, 2022
- Belzutifan Improves Survival in Patients With RCC and VHL - Targeted Oncology - June 22nd, 2022
- Immatics and Editas Medicine Enter Strategic Research Collaboration and Licensing Agreement to Combine Gamma-Delta T Cell Adoptive Cell Therapies and... - June 13th, 2022
- ASCO 2022: Gilead's tough weekend, bispecific progress and 'gamma delta' cell therapy - BioPharma Dive - June 13th, 2022