ESMO 2024: BL-B01D1-201: BL-B01D1, an EGFR x HER3 Bispecific Antibody-drug Conjugate, in Patients with Locally Advanced or Metastatic Urothelial Carcinoma

(UroToday.com) The 2024 ESMO annual meeting included a session on urothelial carcinoma, featuring a presentation by Dr. Dingwei Ye discussing BL-B01D1, an EGFR x HER3 bispecific antibody-drug conjugate, in patients with locally advanced or metastatic urothelial carcinoma.

ESMO 2024: Are Cytotoxics Still the Next Option?

(UroToday.com) The 2024 European Society of Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain was host to the session Therapeutic options beyond AR pathway inhibitors: What do we choose next? Dr. Elena Castro discussed if cytotoxics are still the next option after ARPIs.

ESMO 2024: Prospective Randomized Phase II Trial of Ipilimumab + Nivolumab Versus Standard of Care in Non-Clear Cell RCC: Results of the SUNNIFORECAST Trial

(UroToday.com) The 2024 ESMO annual meeting included a session on kidney cancer, featuring a presentation by Dr. Lothar Bergmann discussing results of the phase II SUNNIFORECAST trial assessing ipilimumab + nivolumab versus standard of care in non-clear RCC. Non-clear cell RCC is a rare and heterogeneous group of more than 20 histological and molecular-defined entities.

ESMO 2024: Final Analysis of the Phase 3 LITESPARK-005 Study of Belzutifan Versus Everolimus in Participants with Previously Treated Advanced Clear Cell RCC

(UroToday.com) The 2024 ESMO annual meeting included a session on kidney cancer, featuring a presentation by Dr. Brian Rini discussing the final analysis of the phase 3 LITESPARK-005 study of belzutifan versus everolimus in participants with previously treated advanced clear cell RCC. Belzutifan is a first-in-class oral HIF-2alpha inhibitor that blocks heterodimerization with HIF-1beta and downstream oncogenic pathways:

ESMO 2024: Tivozanib–Nivolumab vs Tivozanib Monotherapy in Patients with RCC Following 1 or 2 Prior Therapies including an Immune Checkpoint Inhibitor – Results of the Phase III TiNivo-2 Study

(UroToday.com) The 2024 ESMO annual meeting included a session on kidney cancer, featuring a presentation by Dr. Toni Choueiri discussing results of the phase III TiNivo-2 trial assessing tivozanib + nivolumab versus tivozanib monotherapy in patients with RCC following 1 or 2 prior therapies including an immune checkpoint inhibitor. Immune checkpoint inhibitors are the cornerstone of the first line treatment of advanced metastatic RCC, however the optimal sequence in patients whose disease has progressed after treatment with immune checkpoint inhibitors is uncertain, leaving several unanswered questions:

Astellas Presents Scientific Progress in Advanced and Hard-to-Treat Cancers at ESMO 2024

  • Eight abstracts, including two oral presentations, feature new clinical data from Astellas’ oncology portfolio and two lead pipeline programs across a broad range of cancer types
Reno, Nevada (UroToday.com) -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) will highlight new data from across its approved and investigational cancer therapies during the 2024 European Society for Medical Oncology (ESMO) Congress being held in Barcelona, Spain on 13-17 September. Eight abstracts across a broad range of cancer types will be presented, reinforcing Astellas’ commitment to making a meaningful difference to people living with advanced and hard-to-treat cancers. Six abstracts include data spanning prostate, urothelial, gastric and gastroesophageal junction (GEJ), and pancreatic cancers. Two abstracts feature Phase 1 data presented for the first time from immuno-oncology and targeted protein degradation assets.

Tadaaki Taniguchi, MD, PhD, Chief Medical Officer, Astellas:

“The data presented at ESMO are an exciting demonstration of the strength of our portfolio and the transformative potential of our pipeline to help deliver outcomes that matter for patients. Astellas has made a long-term commitment to helping people living with hard-to-treat cancers by both investing in next-generation modalities like targeted protein degradation and immuno-oncology, and by maximizing the number of patients that could benefit from our approved medicines.”
Highlights at the ESMO Congress 2024 include:

  • Data from the Phase 3 EV-302 study, evaluating Nectin-4 expression and response to first-line treatment of enfortumab vedotin in combination with pembrolizumab in previously untreated locally advanced or metastatic urothelial cancer (la/mUC). These results support the combination as a first-line advancement across la/mUC patient subgroups, regardless of Nectin-4 expression.
  • Five-year follow-up data from the Phase 1/2b EV-103 DE/A study, analyzing durable responses and meaningful survival to enfortumab vedotin in combination with pembrolizumab in patients with first-line cis-ineligible la/mUC. These results further support the broad suitability, regardless of cis-eligibility, and long-term benefits of this regimen in la/mUC.
  • Final pooled overall survival data from the Phase 3 SPOTLIGHT and GLOW trials, evaluating zolbetuximab plus chemotherapy as a first-line treatment in patients with HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma whose tumors are Claudin 18.2-positive.
  • Updates involving a Phase 2 trial in progress assessing zolbetuximab in combination with gemcitabine and nab-paclitaxel (GN) versus GN monotherapy as first-line treatment of Claudin 18.2-positive metastatic pancreatic cancer.
  • Phase 3 EMBARK post-hoc analyses, evaluating enzalutamide in combination with leuprolide and as monotherapy versus leuprolide alone in patients with high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer. These results support the benefits of enzalutamide both in combination with leuprolide and as monotherapy in patients aged <70 and ≥70 years.
  • Clinical data from lead pipeline assets: Phase 1 data from ASP3082, the first protein degrader targeting KRAS G12D mutant to enter clinical trials, in patients with advanced pancreatic, colorectal, and non-small cell lung cancer; and preclinical, translational/early clinical data from ASP1570, a novel DGKζ inhibitor, in patients with advanced solid tumors. The results support continued study of these investigational therapies for the treatment of various cancer types.

Astellas Presentations at 2024 ESMO Congress

Enfortumab Vedotin
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Zolbetuximab
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Enzalutamide
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Pipeline
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Source: © Astellas Pharma Inc. (2024 Sept 11). Astellas Presents Scientific Progress in Advanced and Hard-to-Treat Cancers at ESMO 2024 [Press release]. https://www.astellas.com/en/news/29431

AVEO Oncology, an LG Chem company, Announces Acceptance of Late-Breaking Oral Presentation of TiNivo-2 Results at ESMO 2024

Reno, Nevada (UroToday.com) -- AVEO Oncology, an LG Chem company (“AVEO”), announced their late-breaking abstract detailing their Phase 3 TiNivo-2 trial has been selected as a Proffered Paper oral presentation at the 2024 European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain this September 13-17th.

ESMO 2024: Bayer to Present New Prostate Cancer Data and Continued Oncology Portfolio Research at ESMO 2024

  • Bayer will present primary results from the Phase III ARANOTE trial in metastatic hormone-sensitive prostate cancer (mHSPC) for NUBEQA® (darolutamide) as a late-breaking oral presentation
  • Primary results from the European Organisation for Research and Treatment of Cancer’s (EORTC) Phase III PEACE-III study of the first-and-only-approved targeted alpha emitting radiopharmaceutical, XOFIGO® (radium-223 dichloride), in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC), of which Bayer is a key sponsor, will be presented during the Presidential Symposium: Practice-changing trials
  • As part of Bayer’s broader commitment to conduct research in the field of difficult-to-treat cancers, new data on VITRAKVI® (larotrectinib) and a Trial in Progress (TiP) for BAY 2927088 will also be presented at the congress 

Abstracts: LBA68, LBA1, 1629P, LBA71, 1395TiP, 628P, 627P, 1718O, 1925MO, 222P

Reno, Nevada (UroToday.com) -- Bayer will present new oncology data, including a late-breaking, comprehensive analysis from the Phase III ARANOTE trial investigating NUBEQA® (darolutamide) plus androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC), at the European Society for Medical Oncology (ESMO) Congress, taking place in Barcelona, Spain, from September 13-17, 2024.

WCET 2024: Robot Radical Prostatectomy: How to Achieve Better Continence Outcomes

(UroToday.com) On Thursday, August 15, 2024, during the WCET 2024, a plenary panel session was dedicated to discussing robotic radical prostatectomy and strategies to achieve better continence outcomes for patients undergoing the procedure. The session, moderated by Dr. Atsushi Takenaka, MD, PhD, opened with an emphasis on the critical importance of continence outcomes and their profound impact on patients' quality of life.

WCET 2024: Xi and SP Nephroureterectomy and Bladder Cuff

(UroToday.com) At the third World Congress of Endourology and Uro-Technology, WCET 2024, a plenary discussion was dedicated to Urothelial Cancer, with a particular emphasis on Cystectomy and Nephroureterectomy. The session featured a panel of three experts, moderated by a leading authority in the field. Among the panelists, Dr. Ravi Munver and Dr. Jeffery Nix were invited to provide a comprehensive comparison of the XI versus SP robotic approaches for managing nephroureterectomy and bladder cuff excision.

WCET 2024: What are the Most Important Outcomes in Stone Disease?

(UroToday.com) The 2024 World Congress of Endourology and Uro-Technology Conference continued its Thursday morning plenary session with a discussion on important stone disease outcomes, moderated by the esteemed Dr. Hassan Razvi. The session brought together key experts in stone disease to explore outcomes including quality of life, cost, stone-free rates, and complications associated with kidney stone treatment.

WCET 2024: Dietary Management in Urolithiasis Patients: Myths & Truths

Dr. Penniston opened the plenary on "Myths and Misconceptions of Diet and Stone Prevention" with an engaging discussion. She deconstructed the turbulence regarding dietary advice for stone prevention, which in part arises from the complexity of the condition, with various stone types posing unique etiologies and risk factors. She proceeded to refute the traditional “one-size-fits-all” approach to dietary advice, as it is dually illogical and culturally insensitive.

WCET 2024: Leave No Stone Unmeasured: A Comparison of Three Methods for Determining Stone Volume

(UroToday.com) On the fourth day of the WCET 2024 Annual Meeting in Seoul, South Korea, the twenty-fifth moderated poster session included the work of Mr. D. Daniel Baldwin of Loma Linda Urology. Here, he presented work regarding a comparison of volumetric stone measurement methods.

WCET 2024: Panel: How to Manage Multiple Small Renal Masses

(UroToday.com) At the annual WCET 2024, a plenary session included a panel on the management of multiple small renal masses (SRMs). This included a presented argument by respective conservative, intermediate, and prompt approaches moderated by Dr. Woong Kyu Han, MD. Honored panelists included Dr. Jason Y. Lee, MD, MHPE, FRCSC, Dr. Orit Raz, MD, and Dr. Jaime Landman, MD.

WCET 2024: What's Next in Urologic Robotics: Future Perspectives

(UroToday.com) The Thursday morning plenary session at the 2024 World Congress of Endourology and Uro-Technology Conference in Seoul was presented by Dr. Jeremy Teoh on the rapidly evolving world of urologic robotics.

WCET 2024: Assessment Of Post-Operative Outcomes Following Robotic assisted Mini- Percutaneous Nephrolithotomy With The Monarch™ Platform, Urology

(UroToday.com) At the WCET 2024 conference, Dr. Margaret Knoedler unveiled promising early results of robotic-assisted mini-percutaneous nephrolithotomy (mini-PCNL) using the MONARCH™ Platform. The MONARCH™ Platform, developed by Johnson & Johnson MedTech, represents a significant advancement in the field, designed to enhance percutaneous access and streamline the treatment of large renal stones. A retrograde ureteroscope is inserted and operated by the surgeon using a handheld controller.

WCET 2024: Prospective Randomized Trial Comparing High Power Ho:YAG and Thulium Fiber Laser for Ret- Retrograde Ureteroscopy: Preliminary Clinical Results, Environmental Noise Analysis, and Surgeon Satisfaction.

(UroToday.com) At the WCET 2024 conference, Dr. Wilson Molina from the University of Kansas Medical Center presented a study comparing the intraoperative and postoperative outcomes of the SOLTIVE Thulium Fiber Laser (TFL) with the high-power Holmium:yttrium-aluminum-garnet (Ho:YAG) laser during flexible ureteroscopy (fURS). This study also assessed physician satisfaction between the two laser systems, focusing on a variety of critical factors, including but not limited to noise and effort to concentrate.

WCET 2024: Extraperitoneal and Transvesical Approaches to SP RALP

(UroToday.com) This was a special plenary held by two esteemed urologists, Dr. Jihad Kaouk and Dr. Ryan Nelson, who gave a talk on extraperitoneal and transvesical approaches to single-port robotic radical prostatectomy.

WCET 2024: Pulp Fiction: Vitamin C Supplementation and Risk of Kidney Stones

(UroToday.com)In the medical management of stones moderated poster session, Dr. Daniel Jhang presented his research on the impact of vitamin C supplementation on urinary parameters that are crucial in the formation of kidney stones. Vitamin C is one of the most commonly taken supplements and recently the incidence of urolithiasis has risen. This study comes in response to growing concerns over the increased incidence and complexity of kidney stones coinciding with higher vitamin C intake during the COVID-19 pandemic. Vitamin C is thought to contribute to stone formation via oxalate which is byproduct of the metabolism of Vitamin C.

WCET 2024: Getting into Focal Therapy: Why Your Robotic Practice Should Include FT

(UroToday.com) At the WCET 2024 conference, a plenary session focused on the importance of Focal Therapy in robotic practice, with Dr. Indy Gill delivering a compelling presentation. He began by emphasizing his key takeaway: clinical practice should be guided by level 1 evidence, with data-driven planning for localized prostate cancer. Dr. Gill cautioned against treating the entire prostate gland, as it often leads to significant morbidities without offering real oncological benefits. He argued that for men with intermediate-risk prostate cancer, whole-gland treatment might do more harm than good, whereas Focal Therapy presents a balanced approach that can preserve function while maintaining good oncologic outcomes.