ESMO 2024: Fecal Microbiota Transplantation vs Placebo in Patients Receiving Pembrolizumab plus Axitinib for Metastatic Renal Cell Carcinoma. Preliminary Results of the Randomized Phase 2 TACITO Trial.

(UroToday.com) The 2024 European Society of Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain between September 13th and 17th was host to the session Mini oral session: GU tumours, non-prostate. Dr. Chiara Ciccarese presented the preliminary results of the randomized phase 2 TACITO trial, exploring fecal microbiota transplantation (FMT) versus placebo in patients receiving pembrolizumab plus axitinib for metastatic renal cell carcinoma (mRCC).

ESMO 2024: Pre-Treatment Risk Factors for Enfortumab Vedotin-Induced Peripheral Neuropathy in Patients with Advanced Urothelial Carcinoma: Analysis of UNITE

(UroToday.com)The 2024 European Society for Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain between September 13th and 16th, 2024 was host to a genitourinary cancers poster session. Dr. Amanda Nizam presented an analysis of UNITE (Urothelial Cancer Network to Investigate Therapeutic Experiences) evaluating pre-treatment risk factors for enfortumab vedotin-induced peripheral neuropathy in patients with advanced urothelial carcinoma.

ESMO 2024: Invited Discussant: Efficacy of SPLASH and UpFrontPSMA Trials

(UroToday.com) The 2024 European Society for Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain between September 13th and 16th, 2024 was host to a proffered paper session for prostate cancer. Professor Irene Burger provided the discussant for both SPLASH and UpFrontPSMA.

ESMO 2024: Randomized Phase 3 Trial of Neoadjuvant Durvalumab plus Chemotherapy Followed by Radical Cystectomy and Adjuvant Durvalumab in Muscle-Invasive Bladder Cancer (NIAGARA)

(UroToday.com) The 2024 European Society of Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain between September 13th and 17th was host to the session Presidential Symposium II: Practice-changing trials. Dr. Thomas B. Powles presented the results of the NIAGARA trial, the first randomized phase 3 trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer.

ESMO 2024: Novel Serum Glycoproteomic Biomarkers Predict Response to Nivolumab plus Cabozantinib Versus Sunitinib in Advanced RCC: Analysis from CheckMate 9ER

(UroToday.com) The 2024 European Society of Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain between September 13th and 17th was host to the session Mini oral session: GU tumours, non-prostate. Dr. David A. Braun presented an exploratory analysis from CheckMate 9ER exploring Novel serum glycoproteomic biomarkers to predict response to Nivolumab plus Cabozantinib versus Sunitinib in advanced RCC (aRCC).

ESMO 2024: Phase 2 Study of Futibatinib plus Pembrolizumab in Patients with Advanced/Metastatic Urothelial Carcinoma: Final Analysis of Efficacy and Safety

(UroToday.com) The 2024 European Society of Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain between September 13th and 17th was host to the session Mini oral session: GU tumours, non-prostate. Dr. Vadim S. Koshkin presented the final analysis of efficacy and safety of the phase 2 study of futibatinib plus pembrolizumab in patients with advanced/metastatic urothelial carcinoma (mUC).

ESMO 2024: Preliminary Efficacy And Safety Of Disitamab Vedotin With Pembrolizumab In Treatment-Naive HER2-Expressing, Locally Advanced Or Metastatic Urothelial Carcinoma: RC48G001 Cohort C

(UroToday.com) The 2024 European Society of Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain between September 13th and 17th was host to the session Mini oral session: GU tumours, non-prostate. Dr. Matthew D. Galsky presented the preliminary efficacy and safety results of Disitamab Vedotin (DV) With Pembrolizumab (P) for the treatment-naive HER2-Expressing, locally advanced or metastatic urothelial carcinoma.

ESMO 2024: UpFrontPSMA : A Randomized Phase II Study of Sequential 177Lu-PSMA-617 and Docetaxel versus Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

(UroToday.com) The 2024 European Society for Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain was host to a proffered paper session for prostate cancer. Dr. Arun Azad presented the results of UpFrontPSMA, a randomized phase II trial of sequential 177Lu-PSMA-617 plus docetaxel versus docetaxel in metastatic hormone-sensitive prostate cancer (mHSPC). This study was concurrently published in The Lancet Oncology on September 15, 2024.

ESMO 2024: Efficacy of 177Lu-PNT2002 in PSMA-Positive mCRPC Following Progression on an Androgen-Receptor Pathway Inhibitor (SPLASH)

(UroToday.com) The 2024 European Society for Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain was host to a proffered paper session for prostate cancer. Dr. Oliver Sartor presented the first interim results of SPLASH, a phase III trial of 177Lu-PNT2002 in PSMA-positive metastatic castrate-resistant prostate cancer (mCRPC) following progression on an androgen-receptor pathway inhibitor (ARPI).

ESMO 2024: Radioligand Theranostics in Prostate Cancer: Status Quo and New Developments

(UroToday.com) The 2024 ESMO annual meeting included a session on radioligand theranostics in prostate cancer, featuring a presentation by Dr. Ken Herrmann discussing the status quo and new developments. PSMA can be visualized with PSMA-targeted radioligands that can be used for either PET imaging or therapeutic purposes. It is a transmembrane protein expressed on the surface of prostate cancer cells, with no appreciable circulation, and is highly expressed in prostate cancer cells within the tumor tissue (both primary and metastatic) in up to 80% of men with prostate cancer. Theranostics is a field that uses the same/similar targeting compound labeled with either a diagnostic or therapeutic radionuclide:

Lantheus Presents Results from the Primary Analysis of Phase 3 Pivotal SPLASH Trial in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer During ESMO Congress 2024

  • Study met its primary endpoint, demonstrating significant improvement in radiographic progression-free survival
  • Overall Response Rate was 38.1% vs. 12.0% for the ARPI switch arm, including 9.3% Complete Responses
  • Patients demonstrated statistically significant improvement in time to reduction of health-related quality of life (HRQoL) as measured by Functional Assessment of Cancer Therapy—Prostate (FACT-P)
  • Interim Overall Survival Crossover Adjusted Hazard Ratio was <1.00 when Assessed Using Two-Stage and Inverse Probability Censoring Weighting Methods
  • Overall Survival data continue to mature, an update is expected once data are available for 75% of protocol-specified target OS events

Reno, Nevada (UroToday.com) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, presented additional clinical data from initial topline results of the SPLASH Phase 3 trial evaluating the efficacy of 177Lu-PNT2002, a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT), administered at 6.8 GBq every 8 weeks for up to 4 cycles in patients with metastatic castration-resistant prostate cancer (mCRPC) following progression on androgen receptor pathway inhibitor (ARPI). Data were presented during the European Society of Medical Oncology (ESMO) Congress 2024, which is taking place in Barcelona, Spain.

ESMO 2024: Invited Discussant: ETER100, TACITO, and CheckMate 9ER Trials

(UroToday.com) The 2024 European Society of Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain between September 13th and 17th was host to the session Mini oral session: GU tumours, non-prostate. Dr. Camillo Guglielmo Porta reviewed and discussed the presentations of Drs. Sheng, Ciccarese and Braun.

ESMO 2024: EV-302: Exploratory Analysis of Nectin-4 Expression and Response to 1L Enfortumab Vedotin (EV) + Pembrolizumab (P) in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer (la/mUC)

(UroToday.com) The 2024 European Society of Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain was host to the session Mini oral session: GU tumours, non-prostate. Dr. Thomas B. Powles presented an exploratory analysis of Nectin-4 Expression and Response to first line Enfortumab Vedotin (EV) + Pembrolizumab (P) in previously Untreated patients with locally advanced or metastatic urothelial cancer (UC).

ESMO 2024: Anlotinib Combined with Anti-PD-L1 Antibody Benmelstobart (TQB2450) Versus Sunitinib in First-Line Treatment of Advanced Renal Cell Carcinoma -a Randomized, Open-Label, Phase III Study (ETER100)

(UroToday.com) The 2024 European Society of Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain between September 13th and 17th was host to the session Mini oral session: GU tumours, non-prostate. Dr. Xinan Sheng presented the results from the ETER100 phase III randomized, open-label study, exploring Anlotinib combined with anti-PD-L1 antibody Benmelstobart (TQB2450) versus sunitinib in first-line treatment of advanced renal cell carcinoma (RCC).

ESMO 2024: Updates in Penile Cancer

(UroToday.com) The 2024 European Society for Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain between September 13th and 16th, 2024 was host to a session focusing on rare genitourinary cancers. Professor Andrea Necchi provided updates on the treatment of penile cancer.

ESMO 2024: ctDNA Clearance with Neoadjuvant Durvalumab + Tremelimumab + Enfortumab Vedotin for Cisplatin-Ineligible MIBC from the Safety Run-in Cohort of the Phase 3 VOLGA Trial

(UroToday.com) The 2024 ESMO annual meeting included a session on urothelial carcinoma, featuring a presentation by Dr. Alexandra Drakaki, discussing ctDNA clearance with neoadjuvant durvalumab + tremelimumab + enfortumab vedotin for cisplatin-ineligible muscle invasive bladder cancer from the safety run-in cohort of the phase 3 VOLGA trial. The VOLGA safety run-in of neoadjuvant durvalumab + tremelimumab + enfortumab vedotin in cisplatin-ineligible patients with muscle invasive bladder cancer has previously shown promising results (NCT04960709). Pathologic complete response was seen in 6/17 patients and pathologic non-muscle invasive response was seen in 9/17 patients. The safety profile was manageable, with the most common treatment related adverse events being fatigue, maculopapular rash, dysgeusia, dry mouth, and pruritus. Emerging data also suggests that ctDNA may help predict treatment benefit in patients with muscle invasive bladder cancer. At ESMO 2024, Dr. Drakaki and colleagues presented an exploratory analysis of plasma ctDNA from the safety run-in.

ESMO 2024: Non-Clear Cell RCC

(UroToday.com) The 2024 European Society for Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain between September 13th and 16th, 2024 was host to a session focusing on rare genitourinary cancers. Dr. Pedro Barata discussed the current treatment paradigm of non-clear cell renal cell carcinoma (nccRCC).

ESMO 2024: CARE1 Pragmatic Clinical Trial - First Line Randomised Study Platform to Optimize Treatment in Patients with Metastatic Renal Cell Carcinoma

(UroToday.com) The 2024 European Society of Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain was host to the presentation of the trial in progress 1717. Dr. Laurence Albiges presented CARE1 which is a first line randomised study platform to optimize treatment in patients with metastatic renal cell carcinoma (mRCC).

ESMO 2024: Alliance A031501: AMBASSADOR Study of Adjuvant Pembrolizumab in Muscle-Invasive Urothelial Carcinoma vs Observation: Extended Follow-up DFS Results and Metastatic Disease Recurrence Distribution

(UroToday.com) The 2024 ESMO annual meeting included a session on urothelial carcinoma, featuring a presentation by Dr. Andrea Apolo, discussing extended follow-up for disease free survival and an assessment of metastatic disease recurrence pattern from the AMBASSADOR study of adjuvant pembrolizumab in muscle-invasive urothelial carcinoma versus observation. Muscle invasive urothelial carcinoma is an aggressive disease with a noted high relapse rate. Previously, the AMBASSADOR study demonstrated a significant improvement in disease free survival (with 22 month follow-up) for adjuvant pembrolizumab versus observation in patients with high-risk muscle-invasive urothelial carcinoma after radical surgery. At ESMO 2024, Dr. Apolo and colleagues reported extended disease free survival (with 45 month follow-up) analyses, sites of metastatic recurrence, and lymph node status outcomes.

ESMO 2024: Invited Discussant: Improving Outcomes of Localized Urothelial Cancer

(UroToday.com) The 2024 ESMO annual meeting included a session on urothelial carcinoma, featuring a discussant presentation by Dr. Maria De Santis discussing three abstracts including “TAR-200 +/- cetrelimab and cetrelimab alone in patients with BCG-unresponsive high-risk NMIBC: Updated results from SunRISe-1” by Dr. Michiel Van der Heijden, “Alliance A031501: AMBASSADOR Study of Adjuvant Pembrolizumab in Muscle-Invasive Urothelial Carcinoma vs Observation: Extended follow-up DFS results and metastatic disease recurrence distribution” by Dr. Andrea Apolo, and “ctDNA clearance with neoadjuvant durvalumab + tremelimumab + enfortumab vedotin for cisplatin-ineligible MIBC from the safety run-in cohort of the phase 3 VOLGA trial” by Dr. Alexandra Drakaki.