As part of the latest
Oncology Decoded discussion, Manojkumar Bupathi, MD, MS, met with Benjamin Garmezy, MD, after the
2025 American Society of Clinical Oncology (ASCO) Annual Meeting to review data from the late-breaking abstracts, poster sessions, and other presentations of interest that may shift the paradigm across different genitourinary malignancies.
Bupathi is the executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and medical oncologist with Rocky Mountain Cancer Centers specializing in solid tumors and genitourinary cancers. Garmezy is the associate director of genitourinary research and executive cochair of the Genitourinary Cancer Research Executive Committee at SCRI and medical oncologist at SCRI Oncology Partners, also specializing in genitourinary cancers.
These experts highlighted their top abstracts and presentations from this year’s ASCO Annual Meeting, breaking down the results and clinical implications of key research in prostate cancer, bladder cancer, and other patient populations. Noteworthy studies and analyses included the following:
·
Phase 3 AMPLITUDE Trial (NCT04497844)
o Niraparib (Zejula) plus abiraterone acetate (Zytiga) with prednisone (AAP) reached the primary end point of radiographic progression-free survival (rPFS), reducing the risk of radiographic progression or death by 48% (HR, 0.52; 95% CI, 0.37-0.72;
P <.0001) in the
BRCA-mutated metastatic castration-sensitive prostate cancer (CSPC) population and 37% (HR, 0.63; 95% CI, 0.49-0.80;
P = .0001) in
the homologous recombination repair (
HRR)–mutated subgroup vs AAP alone.
o The niraparib combination also improved time to symptomatic progression across the
BRCA-mutant population (HR, 0.44; 95% CI, 0.29-0.68;
P = .0001) and the
HRR-mutant subgroup (HR, 0.50; 95% CI, 0.36-0.69;
P <.0001).
o Overall, data from AMPLITUDE appear to support early genomic testing and reinforce niraparib plus AAP as a new therapeutic option for patients with metastatic CSPC harboring
HRR alterations.
·
Phase 3 NIAGARA Trial (NCT03732677)
o Investigators found circulating tumor DNA (ctDNA) status to be highly prognostic for outcomes among patients who received perioperative durvalumab (Imfinzi) plus neoadjuvant chemotherapy for muscle-invasive bladder cancer (MIBC).
o Across the treatment arms in the NIAGARA trial, ctDNA-negative status conferred improvements in event-free survival (EFS) vs ctDNA positivity (HR, 0.42; 95% CI, 0.30-0.60).
o Adding nivolumab to neoadjuvant chemotherapy increased the rate of ctDNA clearance by 13% vs the use of chemotherapy alone.
·
Phase 2 SURE-02 Trial (NCT05535218)
o Combining perioperative sacituzumab govitecan-hziy (Trodelvy) with pembrolizumab (Keytruda) produced clinical complete responses in 44.4% (95% CI, 27.9%-61.9%) of patients with MIBC.
o The study treatment allowed for bladder preservation without chemoradiotherapy in 74% of patients who refused radical cystectomy.
o The data demonstrated a potentially safe and effective approach for patients with no standard-of-care options at the time of refusing radical cystectomy.
References
1. Attard G, Agarwal N, Graff J, et al. Phase 3 AMPLITUDE trial: niraparib (NIRA) and abiraterone acetate plus prednisone (AAP) for metastatic castration-sensitive prostate cancer (mCSPC) patients (pts) with alterations in homologous recombination repair (HRR) genes.
J Clin Oncol. 2025;43(suppl 17):LBA5006. doi:10.1200/JCO.2025.43.17_suppl.LBA5006
2. Powles T, Van Der Heijden M, Wang Y, et al. Circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA.
J Clin Oncol. 2025;43(suppl 16):4503.doi:10.1200/JCO.2025.43.16_suppl.4503
3. Necchi A, de Jong J, Proudfoot J, et al. First results of SURE-02: A phase 2 study of neoadjuvant sacituzumab govitecan (SG) plus pembrolizumab (pembro), followed by response-adapted bladder sparing and adjuvant pembro, in patients with muscle-invasive bladder cancer (MIBC).
J Clin Oncol. 2025;43(suppl 16):4518. doi:10.1200/JCO.2025.43.16_suppl.4518