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As reported in the Journal of Clinical Oncology by Pfister et al, the French phase III GETUG-AFU V05 VESPER trial showed a nonsignificant improvement in 3-year progression-free survival with dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (dd- MVAC) vs gemcitabine/cisplatin given...
The past year has witnessed tremendous advances in genitourinary oncology. I am pleased to review these findings in this year’s Genitourinary Oncology Almanac from The ASCO Post. I hope that you will find this roadmap helpful in highlighting a selection of these exciting developments. Checkpoint...
Neoadjuvant treatment with the antibody-drug conjugate enfortumab vedotin-ejfv achieved notable antitumor activity in patients with muscle-invasive bladder cancer who are ineligible for treatment with cisplatin, according to preliminary results for cohort H of the EV-103 trial reported at the 2022...
The VESPER phase III trial answers some key questions regarding the optimal management of muscle-invasive bladder cancer. The study found that the neoadjuvant regimen of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (dd-MVAC) was superior to standard gemcitabine/cisplatin in...
As reported inThe New England Journal of Medicine by Dean F. Bajorin, MD, of the Department of Medicine, Memorial Sloan Kettering Cancer Center, and colleagues, an interim analysis of the phase III CheckMate 274 trial has shown improved disease-free survival with adjuvant nivolumab vs placebo...
As reported in The New England Journal of Medicine by Thomas Powles, MD, of Barts Cancer Centre, Queen Mary University of London, and colleagues, a prespecified interim analysis of the phase III EV-301 trial has shown improved overall survival with the antibody-drug conjugate enfortumab...
In a cohort of the phase II TROPHY-U-01 trial reported in the Journal of Clinical Oncology, Scott T. Tagawa, MD, MS, of Weill Cornell Medicine, New York, and colleagues, found that the antibody-drug conjugate sacituzumab govitecan-hziy produced durable responses in patients with metastatic...
Sumanta K. Pal, MD, of City of Hope National Medical Center, discusses some key research developments in kidney cancer, including data on nivolumab and ipilimumab with or without CBM588 in metastatic renal cell carcinoma; intestinal microbiome associated with the development of grade 3 or 4 adverse events in patients with metastatic disease who have been treated with nivolumab plus ipilimumab and probiotic support; the link between TERT promoter mutations and clinical outcome with immune checkpoint inhibitor therapy for advanced urothelial cancer; mutations in the androgen receptor gene in patients with prostate cancer receiving novel androgen deprivation treatments; and findings on waning antibody titers in patients who have received COVID-19 vaccinations (Roundup of Abstracts 371, 561, 374, Posters 38 and 48).
Laura Bukavina, MD, MPH, a Urologic oncology fellow at Fox Chase Cancer Center, has been awarded the ASCO Genitourinary Conquer Cancer Merit Award. She presented the winning abstract, which characterizes the gut microbiome of patients with bladder cancer, at the 2022 ASCO Genitourinary (GU) Cancers ...
Petros Grivas, MD, PhD, of the University of Washington and Fred Hutchinson Cancer Research Center, discusses results from Cohort 3 of the TROPHY-U-01 study, which assessed sacituzumab govitecan-hziy in combination with pembrolizumab in patients with metastatic urothelial cancer who experienced disease progression after platinum-based regimens (Abstract 434).
Massimo Di Maio, MD, of the University of Turin, discusses the Meet-URO12 study, which showed that maintenance niraparib plus best supportive care (BSC) did not prolong progression-free survival, compared with BSC alone, among patients with urothelial cancer that did not progress after first-line platinum-based chemotherapy.
Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, discusses phase II findings from the BAYOU trial, which studied durvalumab in combination with olaparib for first-line treatment of platinum-ineligible patients with unresectable, stage IV urothelial carcinoma. Because secondary analyses indicated a potential progression-free survival benefit with this combination, there may be a role for PARP inhibitors in the treatment of advanced disease with homologous recombination repair mutation (Abstract 437).
Karen E. Knudsen, PhD, MBA, Chief Executive Officer of the American Cancer Society, discusses ways to address the inequities in genitourinary screening, treatment, and outcomes. Her suggestions focus on increasing awareness of screening, identifying risk factors, the dramatic rise in incidence among Hispanic individuals, and the basis for increased mortality in Black men.
Wesley Yip, MD, of Memorial Sloan Kettering Cancer Center, discusses phase II results on neoadjuvant gemcitabine and cisplatin for high-grade upper tract urothelial carcinoma, which was well tolerated and demonstrated a favorable pathologic response rate. Dr. Yip notes that this treatment, given prior to nephroureterectomy, did not significantly delay surgery or increase perioperative complication rates.
Simon J. Crabb, PhD, MBBS, of the Southampton Experimental Cancer Medicine Centre, discusses data from the ATLANTIS trial, in which the authors hypothesized that switch maintenance therapy with the PARP inhibitor rucaparib, in patients who have derived clinical benefit from first-line chemotherapy, may improve outcomes for those with metastatic urothelial carcinoma that harbored a composite biomarker for DNA repair deficiency (Abstract 436).
In a study reported in the Journal of Clinical Oncology, Owens-Walton et al found that minority populations are underrepresented in phase II and III trials targeting prostate, kidney, and bladder cancers taking place in the United States. Study Details In the analysis, the ClinicalTrials.gov...
Daniel P. Petrylak, MD, of Yale Cancer Center, discusses new data on the antitumor activity of neoadjuvant treatment with enfortumab vedotin-ejfv monotherapy in patients with muscle-invasive bladder cancer who are not eligible for cisplatin.
Long-term survival data from the first prospective, randomized biomarker validation trial in patients with muscle-invasive bladder cancer being treated with cisplatin-based chemotherapy before surgery are being reported at the 2022 ASCO Genitourinary Cancers Symposium by Thomas W. Flaig, MD, and...
The antibody-drug conjugate enfortumab vedotin-ejfv is effective in patients with muscle-invasive bladder cancer who are not eligible for cisplatin chemotherapy, according to data from cohort H of the phase IB/II EV-103 clinical trial being presented at the 2022 ASCO Genitourinary Cancers Symposium ...
In a phase II trial reported in the Journal of Clinical Oncology, Funt et al found that the combination of neoadjuvant atezolizumab with gemcitabine and cisplatin resulted in a high rate of tumor downstaging to < pT2N0 in patients with muscle-invasive bladder cancer. Study Details The U.S....
As reported in The Lancet Oncology by Arlene O. Siefker-Radtke, MD, and colleagues, the final analysis of the phase II BLC2001 trial has shown maintained activity of the pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor erdafitinib in patients with locally advanced unresectable ...
The VESPER phase III trial answers some key questions regarding the optimal management of muscle-invasive bladder cancer. The study found that the neoadjuvant regimen of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (dd-MVAC) was superior to standard gemcitabine/cisplatin in...
Thomas Powles, MD, PhD, of Queen Mary University of London, discusses phase II results from the NORSE study, which showed that the kinase inhibitor erdafitinib plus the monoclonal antibody cetrelimab produced meaningful responses in cisplatin-ineligible patients with first-line metastatic or locally advanced urothelial carcinoma and fibroblast growth factor receptor (FGFR) alterations (Abstract LBA27).
On August 19, 2021, the PD-1 inhibitor nivolumab was approved for adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection.1 This is the first approval by the U.S. Food and Drug Administration for adjuvant treatment of patients...
The randomized phase III controlled GETUG/AFU VESPER V05 trial was designed to compare the efficacy of two perioperative treatment regimens—gemcitabine/cisplatin or dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (dd-MVAC)—in patients with muscle-invasive bladder cancer. The...
A study presented by Kevin Ginsburg, MD, and colleagues at the American Urological Association 2021 Annual Meeting has found that among patients treated with radical cystectomy, those with cT1 micropapillary bladder cancer had similar or worse oncologic outcomes compared with patients with cT2...
On July 9, 2021, enfortumab vedotin-ejfv, an antibody-drug conjugate targeting nectin-4, was granted regular approval. The agent is indicated for the treatment of adults with locally advanced or metastatic urothelial cancer who have received a PD-1 or PD-L1 inhibitor and platinum chemotherapy or...
In a phase II study reported in the Journal of Clinical Oncology, Tracy L. Rose, MD, MPH, and colleagues found that neoadjuvant therapy with pembrolizumab, gemcitabine, and primarily split-dose cisplatin resulted in pathologic downstaging (< pT2N0) in more than half of patients undergoing...
On August 31, the U.S. Food and Drug Administration (FDA) revised the label for the anti–PD-1 therapy pembrolizumab for its indication in first-line advanced urothelial carcinoma. The FDA converted the indication from an accelerated approval to a full approval. In addition, as part of the label...
In a phase II trial reported in JAMA Oncology, Sumanta K. Pal, MD, FASCO, and colleagues found that the addition of the ATR inhibitor berzosertib to cisplatin/gemcitabine provided no benefit in patients with metastatic urothelial carcinoma. The triplet did not prolong progression-free survival, and ...
On April 13, 2021, sacituzumab govitecan-hziy was granted accelerated approval to treat patients with locally advanced or metastatic urothelial cancer who had received platinum-containing chemotherapy and either a PD-1 or a PD-L1 inhibitor.1 Supporting Efficacy Data Approval was based on findings...
On August 19, the U.S. Food and Drug Administration (FDA) approved the anti–PD-1 therapy nivolumab (Opdivo) for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of disease recurrence after undergoing radical resection. This is the first FDA approval for adjuvant...
As reported in The New England Journal of Medicine by Dean F. Bajorin, MD, of the Department of Medicine, Memorial Sloan Kettering Cancer Center, and colleagues, an interim analysis of the phase III CheckMate 274 trial has shown improved disease-free survival with adjuvant nivolumab vs placebo...
The role of adjuvant treatment for invasive, high-grade bladder cancer remains controversial and challenging. Sternberg et al reported a statistically significant progression-free survival benefit from adjuvant combination gemcitabine/cisplatin (GC) or MVAC (methotrexate, vinblastine, doxorubicin, ...
As reported inThe New England Journal of Medicine by Dean F. Bajorin, MD, of the Department of Medicine, Memorial Sloan Kettering Cancer Center, and colleagues, an interim analysis of the phase III CheckMate 274 trial has shown improved disease-free survival with adjuvant nivolumab vs placebo...
The results of Cohort 1 of the phase II trial TROPHY-U-01 (IMMU-132-06; ClinicalTrials.gov identifier NCT03547973), published in the Journal of Clinical Oncology by Tagawa et al and reviewed in this issue of The ASCO Post, led to the recent accelerated U.S. Food and Drug Administration (FDA)...
In a cohort of the phase II TROPHY-U-01 trial reported in the Journal of Clinical Oncology, Scott T. Tagawa, MD, MS, of Weill Cornell Medicine, New York, and colleagues, found that the antibody-drug conjugate sacituzumab govitecan-hziy produced durable responses in patients with metastatic...
As reported in The New England Journal of Medicine by Thomas Powles, MD, of Barts Cancer Centre, Queen Mary University of London, and colleagues, a prespecified interim analysis of the phase III EV-301 trial has shown improved overall survival with the antibody-drug conjugate enfortumab...
On July 9, 2021, the U.S. Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv (Padcev), a Nectin-4–directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and...
A study published by Strother et al in BJU International found that patients with muscle-invasive bladder cancer can safely receive cisplatin-based neoadjuvant chemotherapy, even when their tumors are blocking their kidneys. The findings suggest that patients with the most serious type of this...
Peter H. O’Donnell, MD, of The University of Chicago, discusses response and survival results from the phase II KEYNOTE-052 study, which showed that after up to 5 years of follow-up, pembrolizumab continued to elicit clinically meaningful, durable antitumor activity in cisplatin-ineligible patients with advanced urothelial cancer (Abstract 4508).
Matt D. Galsky, MD, of the Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai, discusses results from a phase II trial designed to test gemcitabine and cisplatin plus nivolumab as neoadjuvant therapy in patients with muscle-invasive bladder cancer and to better predict benefit in those who opted out of cystectomy (Abstract 4503).
Sumanta K. Pal, MD, of City of Hope, discusses results from a phase II study that sought to determine whether adding berzosertib, a selective ATR inhibitor, to the standard upfront chemotherapy regimen of cisplatin with gemcitabine may improve outcomes in patients with metastatic urothelial carcinoma (Abstract 4507).
As reported in The Lancet Oncology by Thomas Powles, MD, PhD, and colleagues, the phase III KEYNOTE-361 trial has shown no significant improvement in progression-free or overall survival with first-line pembrolizumab plus platinum-based chemotherapy vs chemotherapy alone in patients with advanced...
In a study reported in a research letter in JAMA Oncology, Corbett et al found that the majority of phase III trials investigating systemic therapy in patients with advanced lung cancer, breast cancer, and melanoma over the past 20 years have excluded or restricted enrollment of those with brain...
As reported in The New England Journal of Medicine by Dean F. Bajorin, MD, and colleagues, an interim analysis of the phase III CheckMate 274 trial has shown improved disease-free survival with adjuvant nivolumab vs placebo among all patients with high-risk muscle-invasive urothelial carcinoma who...
In a presentation of real-world data given during the 2021 ASCO Annual Meeting, Miron et al concluded that the choice of first-line platinum chemotherapy did not result in a significant difference in overall survival benefit among patients with advanced bladder cancer who were able to go on to...
As reported in The Lancet Oncology by Arjun V. Balar, MD, and colleagues, the phase II KEYNOTE-057 trial showed that pembrolizumab produced enduring responses in a cohort of patients with high-risk non–muscle invasive bladder cancer unresponsive to bacillus Calmette-Guérin (BCG) who were ineligible ...
As reported in the Journal of Clinical Oncology by Jonathan E. Rosenberg, MD, and colleagues, the phase III CALGB 90601/Alliance trial has shown no improvement in overall survival with the addition of bevacizumab to gemcitabine/cisplatin in patients with metastatic urothelial carcinoma. Study...
In a perspective in The New England Journal of Medicine, Julia A. Beaver, MD, and Richard Pazdur, MD, of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE), discussed issues surrounding “dangling” accelerated approvals of anti–PD-1/PD-L1 antibodies—ie, approvals for...