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Highlights from the 2024 ASCO Genitourinary Cancers Symposium |
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| Enfortumab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Previously Untreated Locally Advanced Metastatic Urothelial Carcinoma: Subgroup Analyses Results from EV-302, a Phase 3 Global Study
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| Michiel Simon van der Heijden, MD, Ph.D.
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| Michiel van der Heijden presented subgroup analyses from the EV-302 trial, a phase 3 study comparing enfortumab vedotin plus pembrolizumab to chemotherapy in previously untreated locally advanced metastatic urothelial carcinoma. The combination of enfortumab vedotin plus pembrolizumab significantly improved PFS and OS compared to platinum-based chemotherapy across various subgroups, supporting its role as a new standard of care for this population.
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| Cabozantinib plus Pembrolizumab as First-line Therapy for Cisplatin-ineligible Advanced Urothelial Carcinoma (PemCab)
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| Rohit K. Jain, MD, MPH
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| Rohit Jain presented the results of the PemCab study, a non-randomized phase II trial evaluating cabozantinib plus pembrolizumab as first-line therapy for cisplatin-ineligible advanced urothelial carcinoma. These findings suggest that the combination of cabozantinib and pembrolizumab may be a viable treatment option for patients with cisplatin-ineligible urothelial carcinoma, providing a potential new therapeutic avenue for this population.
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| BCG Shortage: What’s on the Horizon to Replace?
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Joshua J Meeks, MD, Ph.D.
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| Josh Meeks discussed the shortage of Bacillus Calmette-Guérin (BCG) for urothelial carcinoma and potential replacements. With BCG supply challenges, various strategies are being explored, including the S1602 trial comparing the Tokyo172 BCG strain to TICE, and gemcitabine plus docetaxel as a promising alternative.
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| SAKK 06/19 - Intravesical Recombinant BCG Followed by Perioperative Chemo-Immunotherapy for Patients with Muscle-Invasive Bladder Cancer: A Multicenter, Single Arm Phase 2 Trial
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| Richard Cathomas, MD
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| The SAKK 06/19 trial, presented Richard Cathomas, focuses on a phase II study investigating intravesical VPM1002BC followed by perioperative chemo-immunotherapy for operable MIBC. The trial aims to enhance outcomes in MIBC by combining novel recombinant BCG (VPM1002BC) with systemic chemo-immunotherapy.
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| GDFather-Neo - Neutralizing GDF-15 in MIBC: A Neoadjuvant Immunotherapy trial of visugromab (CTL-002) in combination with the anti-PD1 antibody nivolumab
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| Andrea Necchi, MD
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| The GDFather-Neo trial focuses on neoadjuvant immunotherapy for muscle-invasive bladder cancer (MIBC). The trial investigates the combination of visugromab (CTL-002), a GDF-15 neutralizing antibody, with the anti-PD1 antibody nivolumab, aiming to enhance pathologic complete response rates in MIBC patients ineligible for or opting out of neoadjuvant chemotherapy.
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| MAIN-CAV: Phase III Randomized Trial of Maintenance Cabozantinib and Avelumab vs Avelumab After First-Line Platinum-Based Chemotherapy in Patients with Metastatic Urothelial Cancer
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| Shilpa Gupta, MD
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| Shilpa Gupta presented the MAIN-CAV trial focusing on metastatic urothelial carcinoma patients who do not progress after first-line platinum-based chemotherapy. The phase III randomized trial aims to assess the efficacy and safety of maintenance therapy with cabozantinib and avelumab versus avelumab alone.
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| PIVOT-006: A phase 3, Randomized Study of Cretostimogene Grenadenorepvec vs Observation for the Treatment of Intermediate Risk Non-muscle Invasive Bladder Cancer Following TURBT
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| Robert S. Svatek, MD
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| In this presentation, Robert Svatek discussed the PIVOT-006 study focusing on the treatment of intermediate-risk non-muscle invasive bladder cancer following transurethral resection of bladder tumor. The phase 3, randomized study compares cretostimogene grenadenorepvec, an intravesically delivered adenovirus with oncolytic immunotherapy properties, with observation.
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| A Phase 1 Study of IO102-IO103 Vaccine Plus Pembrolizumab in Patients with BCG-intolerant or Unresponsive Non-Muscle Invasive Bladder Cancer
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| Sumana Veeravelli, MD
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| Sumana Veeravelli presented a phase 1 study of the IO102-IO103 vaccine in combination with pembrolizumab for patients with BCG-intolerant or unresponsive non-muscle invasive bladder cancer. This investigational therapeutic cancer vaccine aims to stimulate T-cells against indoleamine-2,3-dioxygenase 1 and/or PD-L1 positive cells in the tumor microenvironment, potentially enhancing the antitumor immune response.
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| Pembrolizumab with Favezelimab or Vibostolimab for Patients with BCG–Unresponsive High-Risk Non–Muscle Invasive Bladder Cancer: Phase 2 KEYNOTE-057 Cohort C
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| Girish Kulkarni, MD, Ph.D.
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| Girish Kulkarni discussed Cohort C of the KEYNOTE-057 trial which focuses on evaluating the efficacy and safety of pembrolizumab in combination with either the TIGIT inhibitor vibostolimab or the LAG-3 inhibitor favezelimab for patients with BCG-unresponsive high-risk NMIBC. The study aims to assess the antitumor activity, complete response rates, PFS, OS, and safety of these co-formulations, providing potential novel combinations to enhance the efficacy of pembrolizumab in treating high-risk NMIBC.
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| Adverse Effects and Discontinuation of Pembrolizumab in BCG Refractory Non-Muscle Invasive Bladder Cancer |
| Borivoj Golijanin |
| Borivoj Golijanin presented the results of a study evaluating the adverse effects and discontinuation rates of pembrolizumab in patients with BCG-refractory non-muscle invasive bladder cancer (NMIBC). The analysis included 18 patients with a median age of 74.5 years, and the median follow-up was 17.5 months. The findings indicated that treatment with pembrolizumab was not well-tolerated, leading to a high rate of discontinuation primarily due to grade ≥2 toxicity. |
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| A Phase II Study of Tislelizumab Monotherapy as Neoadjuvant Treatment for Cisplatin-Ineligible High-Risk Upper Tract Urothelial Carcinoma |
| Jiwei Huang |
| Jiwei Huang presented the results of a phase II study evaluating tislelizumab monotherapy as neoadjuvant treatment for cisplatin-ineligible patients with high-risk upper tract urothelial carcinoma (UTUC). The study included 16 patients who received tislelizumab for a maximum of 4 cycles before undergoing surgery. The primary endpoint was the pathological complete response rate, and secondary endpoints included pathological response rate, disease-free survival, and safety. |
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| Blue Light Cystoscopy Versus White Light Cystoscopy for the Detection of Bladder Cancer in China: An Analysis of Unpublished Clinical Trial and Real-World Data |
| Hanzhong Li, MD |
| Hanzhong Li presented an analysis of unpublished clinical trials and real-world data comparing blue light cystoscopy to white light cystoscopy for the detection of bladder cancer in China. The results from both the RCT and real-world study confirmed the superiority of blue light cystoscopy, based on innovative LED technology with hexaminolevulinate (HAL), compared to white light cystoscopy for detecting bladder cancer in Chinese populations. |
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| BladderGATE: Atezolizumab + intravesical BCG Upfront Combination in Patients with High-risk NMIBC—Phase I-II ONCOSUR Study
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| Daniel Castellano, MD
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| Daniel Castellano presented the results of the BladderGATE study, a phase I-II ONCOSUR trial evaluating the combination of atezolizumab plus intravesical Bacillus Calmette-Guerin (BCG) as an upfront treatment in patients with high-risk non-muscle invasive bladder cancer. The results showed that the upfront combination of atezolizumab and intravesical BCG was feasible and safe, with a 2-year local recurrence rate of 14%, and 8% of patients showed evidence of progression to muscle invasiveness.
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| Interim Analysis of a Phase I/Ib Study of Enfortumab Vedotin plus Cabozantinib in Patients with Metastatic Urothelial Carcinoma
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| Jacqueline T. Brown, MD
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| Jacqueline Brown presented an interim analysis of a phase I/Ib study evaluating the combination of enfortumab vedotin plus cabozantinib in patients with metastatic urothelial carcinoma. The results showed that all six patients in the dose escalation cohort achieved a partial response, and the recommended phase 2 dose was determined to be cabozantinib 20 mg daily. The combination demonstrated promising efficacy with an acceptable safety profile in this preliminary analysis.
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| First Results of NURE-Combo: A Phase 2 Study of Neoadjuvant Nivolumab and Nab-paclitaxel Followed by Postsurgical Adjuvant Nivolumab in Patients with MIBC
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| Chiara Mercinelli, MD |
| Chiara Mercinelli presented the initial results of the NURE-Combo phase 2 study, which investigated neoadjuvant nivolumab plus nab-paclitaxel followed by postsurgical adjuvant nivolumab in patients with muscle-invasive bladder cancer (MIBC). These results showed that 39% of patients achieved pCR, and 73% had a ≤ypT1N0 response. No disease progression occurred during neoadjuvant treatment, and the 12-month event-free survival was 89% |
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| Sequential Endoluminal Gemcitabine and Docetaxel vs BCG for the Treatment of High-Grade UTUC
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| Ian McElree
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| Ian McElree presented the results of a study comparing sequential endoluminal gemcitabine plus docetaxel versus bacillus Calmette-Guerin (BCG) for the treatment of high-grade upper tract urothelial carcinoma (UTUC). The study was a retrospective analysis of 59 patients with 71 upper tract tumors, of which 35 were treated with gemcitabine/docetaxel, and 36 received BCG.
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