ESMO 2024: Invited Discussant: Phase 3 ARANOTE Trial, Phase 3 Evaluation of Transdermal Estradiol vs LHRH Agonists and Ancillary Study of the PEACE-1

(UroToday.com) The 2024 ESMO annual meeting included a session on prostate cancer, featuring a discussant presentation by Dr. Niven Mehra discussing three abstracts including “Efficacy and safety of darolutamide plus ADT in patients with mHSPC from the phase 3 ARANOTE trial” by Dr. Fred Saad, “Prostate cancer efficacy results from a randomized phase 3 evaluation of transdermal estradiol versus LHRH agonists for androgen suppression in M0 prostate cancer” by Dr. Ruth Langley, and “Phenotypic and genomic characterization of de novo metastatic prostate cancer: an ancillary study of the PEACE-1 phase 3 trial” by Dr. Cedric Pobel.

ESMO 2024: Systemic Treatment Options

(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 Updates in the management of advanced renal cell carcinoma. Dr. Teresa Alonso Gordoa discussed systemic treatment options for the management of advanced renal cell carcinoma.

ESMO 2024: Is There a Role for Radiation Therapy in Advanced RCC?

(UroToday.com) The 2024 European Society of Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain was host to the session Updates in the management of advanced renal cell carcinoma. Dr. Chad Tang posed the question of whether there is a role for radiation therapy in advanced RCC. and moved on to discuss this important topic.

ESMO 2024: Efficacy and Safety of Darolutamide plus ADT in Patients with mHSPC from the Phase 3 ARANOTE Trial

(UroToday.com) The 2024 ESMO annual meeting included a session on prostate cancer, featuring a presentation by Dr. Fred Saad discussing the efficacy and safety of darolutamide plus ADT in patients with mHSPC from the phase 3 ARANOTE trial. In ARASENS, darolutamide + ADT + docetaxel significantly improved overall survival versus ADT + docetaxel in patients with mHSPC, and incidences of treatment-emergent adverse events were similar in both groups.1 The phase 3 global ARANOTE trial (NCT04736199) compared darolutamide + ADT versus ADT in patients with mHSPC. At ESMO 2024, Dr. Saad presented the primary results of the trial.

ESMO 2024: Phenotypic and Genomic Characterization of De Novo Metastatic Prostate Cancer: An Ancillary Study of the PEACE-1 Phase 3 Trial

(UroToday.com) The 2024 ESMO annual meeting included a session on prostate cancer, featuring a presentation by Dr. Cédric Pobel discussing phenotypic and genomic characterization of de novo metastatic prostate cancer from the phase 3 PEACE-1 trial. Recently, the addition of abiraterone acetate + prednisone to docetaxel and ADT became a standard of care for metastatic castration-sensitive prostate cancer (mCSPC) following results of PEACE-1:1

ESMO 2024 Late-Breaking Data: Phase III ARANOTE Trial Shows NUBEQA® (darolutamide) Significantly Reduced Risk of Radiological Progression or Death in Metastatic Hormone-Sensitive Prostate Cancer

  • In the Phase III ARANOTE trial, NUBEQA® (darolutamide) plus androgen deprivation therapy (ADT) demonstrated an improvement in radiological progression-free survival (rPFS) with a 46% statistically significant reduction in the risk of progression or death (HR 0.54; 95% CI 0.41-0.71; P<0.0001) compared to placebo plus ADT
  • With these results, NUBEQA plus ADT now has demonstrated efficacy data in metastatic hormone-sensitive prostate cancer (mHSPC) both with and without docetaxel in the pivotal Phase III ARANOTE and ARASENS trials
  • Results were consistent with the established safety profile of NUBEQA with no new safety signals observed
  • ARANOTE results have been published simultaneously in The Journal of Clinical Oncology

Reno, Nevada (UroToday.com) -- Results from the investigational pivotal Phase III ARANOTE trial demonstrated that NUBEQA® (darolutamide) plus androgen deprivation therapy (ADT) showed a statistically significant and clinically meaningful improvement in radiological progression-free survival (rPFS) compared to placebo plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC). 1 The results were presented today as a late-breaking oral presentation at the 2024 European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain, and published simultaneously in The Journal of Clinical Oncology.

ESMO 2024: INSPIRE: Phase 2 Trial of Nivolumab 3mg/kg and Ipilimumab 1mg/kg in Molecularly Selected Patients with mCRPC

(UroToday.com) The 2024 ESMO annual meeting included a session on prostate cancer, featuring a presentation by Dr. Niven Mehra discussing nivolumab 3mg/kg and ipilimumab 1mg/kg in molecularly selected patients with mCRPC. Anti-PD1 immune checkpoint blockade is currently approved as monotherapy for mCRPC patients with a tumor mutational burden (TMB) of >10 mutations per megabase (mut/Mb) or mismatch repair deficiency.

ESMO 2024: RAPSON: Open-Label, Multicenter Randomized Trial of Radium-223 -> Docetaxel Versus Docetaxel -> Radium-223 Sequence in mCRPC with Prospective Biomarker Evaluation

(UroToday.com) The 2024 ESMO annual meeting included a session on prostate cancer, featuring a presentation by Dr. Vincenza Conteduca discussing results from RAPSON, an open-label multicenter randomized trial of Radium-223 -> docetaxel versus docetaxel -> Radium-223 sequence in mCRPC with prospective biomarker evaluation. Defining the most effective treatment sequence between the α emitter Radium-223 and docetaxel is pivotal for optimizing bone-dominant mCRPC outcomes.

ESMO 2024: The Role of Cytoreductive Nephrectomy in the Immunotherapy Era

(UroToday.com) The 2024 European Society for Medical Oncology (ESMO) Annual Congress held in Barcelona, Spain was host to a session summarizing updates in the management of advanced renal cell carcinoma (RCC). Dr. Mir discussed the role of cytoreductive nephrectomy in the immunotherapy era.

ESMO 2024: CC-94676-PCA-001: Clinical Activity of BMS-986365, a Dual Androgen Receptor Ligand-Directed Degrader and Antagonist, in Heavily Pretreated Patients with mCRPC

(UroToday.com) The 2024 ESMO annual meeting included a session on prostate cancer, featuring a presentation by Dr. Dana Rathkopf discussing the clinical activity of BMS-986365 (CC-94676) in heavily pretreated patients with mCRPC. The majority of mCRPC remains AR-dependent even if resistant to AR pathway inhibitors such as enzalutamide and abiraterone. BMS-986365 is a heterobifunctional, oral therapy designed to inhibit AR activity via a first-in-class dual mechanism of AR degradation and antagonism:

ESMO 2024: Prostate Cancer Efficacy Results from a Randomized Phase 3 Evaluation of Transdermal Estradiol Versus LHRH Agonists for Androgen Suppression in M0 Prostate Cancer

(UroToday.com) The 2024 ESMO annual meeting included a session on prostate cancer, featuring a presentation by Dr. Ruth Langley discussing efficacy results from a randomized phase 3 evaluation of transdermal estradiol versus luteinizing hormone-releasing hormone (LHRH) agonists for androgen suppression in M0 prostate cancer. Compared to LHRH agonists, transdermal estradiol lowers testosterone more rapidly, maintains bone mineral density, and improves metabolic outcomes and quality of life. Importantly, transdermal administration avoids the cardiovascular toxicity of oral estrogen.

ESMO 2024: Adding Metformin to ADT for Patients with mHSPC: Overall Survival Results from the Multi-Arm, Multi-Stage Randomized Platform Trial STAMPEDE

(UroToday.com) The 2024 ESMO annual meeting included a session on prostate cancer, featuring a presentation by Dr. Silke Gillessen discussing results from STAMPEDE assessing the addition of metformin to ADT for patients with mHSPC. ADT is standard of care in advanced prostate cancer, but it has metabolic adverse effects. Metformin is a widely used, well tolerated anti-diabetic agent. Several studies suggest metformin has anti-cancer activity in different malignancies, including prostate cancer. Dr. Gillessen and colleagues hypothesized that metformin also reduces the development of ADT-induced metabolic adverse effects, possibly improving overall survival via these mechanisms.

ESMO 2024: Invited Discussant: CONTACT-02 Study and STAMPEDE Docetaxel Trials

(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. Rana McKay delivered the discussant session for CONTACT-02 and the post-hoc analysis of STAMPEDE Docetaxel assessing Decipher® as a potential predictive biomarker for overall survival in metastatic hormone sensitive prostate cancer (mHSPC) patients receiving docetaxel doublet therapy.

ESMO 2024: Cabozantinib plus Atezolizumab versus 2nd Novel Hormonal Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer: Final Overall Survival Results of the Phase III, Randomized, CONTACT-02 Study

(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. Neeraj Agarwal presented the final overall survival results of CONTACT-02, a phase III randomized trial of cabozantinib plus atezolizumab versus a 2nd novel hormonal therapy (NHT) in patients with metastatic castrate-resistant prostate cancer (mCRPC).

ESMO 2024: Decipher® mRNA Score for Prediction of Survival Benefit from Docetaxel at Start of Androgen Deprivation Therapy for Advanced Prostate Cancer: An Ancillary Study of the STAMPEDE Docetaxel Trials

(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. Emily Grist presented the results of an ancillary study of the STAMPEDE Docetaxel trial evaluating the genomic classifier Decipher® mRNA score for predicting a survival benefit with docetaxel doublet therapy intensification for metastatic hormone sensitive prostate cancer (mHSPC) patients.

ESMO 2024: Avelumab First-Line Maintenance in Advanced Urothelial Carcinoma: Conditional Survival and Long-Term Safety in Patients Treated for ≥1 or ≥2 Years in JAVELIN Bladder 100

(UroToday.com) The 2024 ESMO annual meeting included a session on urothelial carcinoma, featuring a presentation by Dr. Petros Grivas discussing conditional survival and long-term safety in patients treated for ≥1 or ≥2 years in the JAVELIN Bladder 100 trial. In the JAVELIN Bladder 100 phase 3 trial (NCT02603432), avelumab first-line maintenance + best supportive care significantly prolonged overall survival and progression-free survival vs best supportive care alone in patients with advanced urothelial carcinoma that had not progressed with first-line platinum-based chemotherapy.1

New Data from TAR-200 Phase 2b SunRISe-1 Study Show 84 Percent Complete Response Rate in Patients with High-Risk Non-Muscle-Invasive Bladder Cancer

Investigational TAR-200 monotherapy demonstrates high complete response rate without the need for reinduction or additive therapy in patients who are Bacillus Calmette-Guérin (BCG)-unresponsive

Reno, Nevada (UroToday.com) -- Johnson & Johnson (NYSE:JNJ) announced additional results from the pivotal Phase 2b SunRISe-1 study, supporting the safety and efficacy profile of investigational TAR-200 for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC). New data were featured in a late-breaking oral presentation at the European Society of Medical Oncology (ESMO) 2024 Congress (Abstract #LBA85).

ESMO 2024: Invited Discussant: A 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. Petros Grivas discussed the presentation by Dr. Thomas B. Powles who presented the results of the NIAGARA trial, a randomized phase 3 trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer.

ESMO 2024: TAR-200 +/- Cetrelimab and Cetrelimab Alone in Patients with BCG-Unresponsive High-Risk NMIBC: Updated Results from SunRISe-1

(UroToday.com) The 2024 ESMO annual meeting included a session on urothelial carcinoma, featuring a presentation by Dr. Michiel Van der Heijden, discussing updated results from SunRISe-1 assessing TAR-200 +/- cetrelimab and cetrelimab alone in patients with BCG-unresponsive high-risk NMIBC. Unfortunately, patients with BCG unresponsive high-risk NMIBC have limited treatment options. Standard of care for these patients is radical cystectomy, which is a life-changing operation associated with considerable morbidity and impact on quality of life, and a 90 day mortality risk of up to 8%. Limited US FDA approved treatment options are available to treat BCG-unresponsive high-risk NMIBC CIS, with 12 month complete response rates of:

ESMO 2024: Invited Discussant: Futibatinib Plus Pembrolizumab, Retrospective Assessment of Nectin-4 Expression, and Disitamab Vedotin

(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. Aristotelis Bamias was the invited discussant to summarize and critically appraised the presentations by Drs Vadim S. Koshkin, Thomas B. Powles, and Matthew D. Galsky exploring different treatment options for locally advanced and metastatic urothelial (la/mUC) carcinoma.