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As reported in the Journal of Clinical Oncology by Jacqueline Vuky, MD, of Oregon Health & Science University, Portland, and colleagues, long-term follow-up in the phase II KEYNOTE-052 study has shown durable responses with first-line pembrolizumab in cisplatin-ineligible locally advanced or...
In a phase II study reported in the Journal of Clinical Oncology,1 Matthew D. Galsky, MD, of The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, and colleagues found that maintenance pembrolizumab produced additional responses and improved progression-free survival vs...
Pembrolizumab: On January 8, 2020, pembrolizumab (Keytruda) was approved by the U.S. Food and Drug Administration (FDA) for bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or...
It may be possible to use a platinum-free combination as first-line treatment for advanced or metastatic urothelial carcinoma in cisplatin-ineligible patients, if the results of the phase Ib/II EV-103 trial hold up. The combination of the newly approved antibody-drug conjugate (enfortumab vedotin)...
As reported in The New England Journal of Medicine by Loriot et al, the fibroblast growth factor receptor 1-4 tyrosine kinase inhibitor erdafitinib showed activity in FGFR-altered advanced urothelial carcinoma.1 The study enrolled patients from sites in 14 countries between May 2015 and March 2018. ...
Maintenance therapy with avelumab and best supportive care significantly prolonged overall survival vs best supportive care alone in patients with advanced urothelial carcinoma that did not progress on first-line platinum-based chemotherapy, according to an interim analysis of the phase III JAVELIN ...
Over the past year, we have seen significant advances in the treatment of prostate, kidney, and urothelial cancers that will benefit patients now and in the future. We have learned about the final results of important clinical trials across multiple genitourinary cancers disease states leading to...
In a single-center phase II trial reported in The Lancet Oncology, Andrea Apolo, MD, and colleagues found that the multikinase inhibitor cabozantinib showed activity in a cohort of patients with platinum-refractory metastatic urothelial carcinoma. As noted by the investigators, in addition to...
Study discussant Daniel Y. Heng, MD, MPH, a medical oncologist at Tom Baker Cancer Centre, University of Calgary, Canada, called the negative trial results important. IMvigor010 randomly assigned patients with high-risk muscle-invasive urothelial carcinoma to adjuvant atezolizumab or observation...
Adjuvant atezolizumab, a PD-L1–blocking antibody, failed to meet the primary endpoint of disease-free survival in patients at high risk of recurrence of muscle-invasive bladder cancer compared with observation alone, according to the primary analysis of the IMvigor010 trial reported during the...
“These data are solid, showing a 7-month improvement in overall survival in patients with stable disease or better after first-line chemotherapy. This is roughly a 50% improvement in survival, which is clinically meaningful. Also, progression-free survival was significantly increased with...
According to an interim analysis of the phase III JAVELIN Bladder 100 trial, rates of survival among patients with advanced urothelial carcinoma who did not progress on first-line platinum-based chemotherapy were significantly prolonged by maintenance therapy with avelumab and best supportive care...
The global outbreak of the COVID-19 pandemic forced many cancer societies, including ASCO, to cancel their in-person meetings this year and instead present the latest advancements and new approaches in oncology care via a virtual platform. For the first time in its 56-year history, the ASCO Annual...
On June 30, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. JAVELIN Bladder 100 Efficacy of avelumab...
In patients with metastatic urothelial carcinoma, a novel combination of biomarkers from baseline tumor tissues was predictive of improved clinical responses and prolonged survival following treatment with immune checkpoint inhibitors, according to findings published by Goswami et al in Science...
As reported in the Journal of Clinical Oncology by Vuky et al, long-term follow-up in the phase II KEYNOTE-052 study has shown durable responses with first-line pembrolizumab in cisplatin-ineligible locally advanced or metastatic urothelial cancer, with higher response rates and longer survival in...
As reported in The Lancet by Matthew D. Galsky, MD, of Icahn School of Medicine at Mount Sinai, and colleagues, the phase III IMvigor130 trial has shown prolonged progression-free survival with first-line atezolizumab plus platinum-based chemotherapy vs platinum-based chemotherapy alone in patients ...
Christopher Sweeney, MBBS, of Dana-Farber Cancer Institute, talks with Thomas Powles, MD, PhD, of Queen Mary University of London, about the first study to demonstrate a survival advantage with avelumab for metastatic urothelial cancer. In the trial, avelumab improved median overall survival by 21.4 months compared with 14.3 months with best supportive care (Abstract LBA1).
“These data are solid, showing a 7-month improvement in overall survival in patients with stable disease or better after first-line chemotherapy. This is roughly a 50% improvement in survival, which is clinically meaningful. Also, progression-free survival was significantly increased with...
Maintenance therapy with avelumab and best supportive care significantly prolonged overall survival vs best supportive care alone in patients with advanced urothelial carcinoma that did not progress on first-line platinum-based chemotherapy, according to an interim analysis of the phase III...
On April 15, 2020, mitomycin gel was approved for the treatment of adult patients with low-grade upper tract urothelial cancer.1,2 Mitomycin gel is for pyelocalyceal use alone and not for intravenous, topical, or oral administration. Supporting Efficacy Data Approval was based on findings in the...
As Thomas Powles, MD, PhD, of Queen Mary University of London, prepares to deliver his late-breaking presentation at the ASCO20 Virtual Scientific Program (LBA-1), he talks with Christopher Sweeney, MBBS, of Dana-Farber Cancer Institute, about current therapy: PD1/PDL1 inhibition in second-line treatment and as monotherapy in the first-line setting, as well as the concept of maintenance switch.
Low-intensity cystoscopic surveillance may be a viable option for patients with high-risk, non–muscle invasive bladder cancer, according to data from a paper presented to the media during a special session moderated by the American Urological Association (AUA) on May 15. The research was also...
In the single-arm phase III OLYMPUS trial reported in The Lancet Oncology, Kleinmann et al found that primary chemoablation of low-grade upper tract urothelial carcinoma using a mitomycin-containing reverse thermal gel (UGN-101) resulted in disease eradication in more than half of patients. As...
In a phase II study reported in the Journal of Clinical Oncology, Matthew D. Galsky, MD, and colleagues found that maintenance pembrolizumab produced additional responses and improved progression-free survival vs placebo in patients with metastatic urothelial cancer who had at least stable disease...
On April 15, the U.S. Food and Drug Administration (FDA) approved mitomycin (Jelmyto) for adult patients with low-grade upper tract urothelial cancer. OLYMPUS Trial Efficacy determination was based on OLYMPUS, an ongoing, single-arm, multicenter trial enrolling 71 patients with treatment-naive or...
Over the past week, the U.S. Food and Drug Administration (FDA) granted Priority Review to an immunotherapeutic agent for solid tumors with a high tumor mutational burden and to a combination treatment for the first-line treatment of metastatic or recurrent non–small cell lung cancer. The agency...
Attendees gathered at the 2020 Genitourinary Cancers Symposium in San Francisco to hear the latest news about treating patients with cancers of the prostate, bladder, kidneys, and testicles. In addition to the comprehensive coverage of the meeting in The ASCO Post, here are some brief highlights...
The U.S. Food and Drug Administration (FDA) recently approved a new dose for a biosimilar referencing trastuzumab and granted Fast Track designations to agents for patients with urothelial cancer and follicular lymphoma. Approval of Multidose Vial of Trastuzumab Biosimilar The FDA approved a...
Philip J. Saylor, MD, Attending Physician at Massachusetts General Hospital and Assistant Professor at Harvard Medical School, Boston, commented on this study. “The results that were presented are clearly exciting and cause us to look forward to a likely phase III study of this strategy. The high...
It may be possible to use a platinum-free combination as first-line treatment for advanced or metastatic urothelial carcinoma in cisplatin-ineligible patients, if results of the phase Ib/II EV-103 trial hold up. The combination of the newly approved antibody-drug conjugate (enfortumab vedotin) and...
In the phase III POUT trial, reported in The Lancet, Alison Birtle, MD, and colleagues found that adjuvant gemcitabine/platinum chemotherapy was associated with improved disease-free survival vs surveillance in patients with locally advanced urothelial carcinoma of the upper urinary tract. As...
This week, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for non–small cell and small cell lung cancers, as well as for diffuse large-B cell lymphoma (DLBCL); Breakthrough Therapy designation to an antibody-drug conjugate for bladder cancer; and a double Fast...
On January 8, 2020, pembrolizumab was approved for treatment of patients with bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.1,2...
Nicholas D. James, PhD, MBBS, of The Institute of Cancer Research in London, discusses results from a phase I/II feasibility study that showed the combination of cetuximab, chemoradiation, fluorouracil, and mitomycin yields high bladder cancer control rates with acceptable toxicity and quality of life, meriting further evaluation in a randomized trial (Abstract 491).
Syed A. Hussain, MD, of the University of Sheffield, discusses phase II findings comparing nintedanib or placebo in combination with gemcitabine and cisplatin in locally advanced muscle-invasive bladder cancer. The data showed that adding nintedanib was safe and well tolerated, with a significant improvement in progression-free and overall survival at 1 and 2 years (Abstract 438).
Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, discusses study results which showed that, in first-line cisplatin-ineligible patients with metastatic urothelial carcinoma, enfortumab vedotin/pembrolizumab demonstrated activity and durability, with a manageable safety profile (Abstract 441).
In patients with metastatic urothelial carcinoma, platinum chemotherapy is the standard of care in the first-line setting; however, for patients who are ineligible for platinum treatment, the alternative standard—gemcitabine plus carboplatin—can be poorly tolerated and have limited durability and...
In studies to be presented at the 2020 Genitourinary Cancers Symposium (Abstracts 649 and 665), researchers examined the prevalence of fear of cancer recurrence in patients with renal cell carcinoma and evaluated the prognostic understanding patients with genitourinary cancer possess of their...
In the phase I EV-101 trial reported in the Journal of Clinical Oncology, Rosenberg et al found that the antibody-drug conjugate enfortumab vedotin had no maximum tolerated dose and was active in patients with metastatic urothelial carcinoma at the dose selected for phase II evaluation. The agent...
As reported in The Lancet Oncology by Brian I. Rini, MD, and colleagues, the phase III TIVO-3 trial has shown a statistically significant increase in progression-free survival with tivozanib vs sorafenib as a third- or fourth-line treatment for advanced renal cell carcinoma. Study Details The...
On December 18, 2019, the antibody-drug conjugate enfortumab vedotin-ejfv (PadcevTM) was granted accelerated approval for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed cell death protein 1 (PD-1) or programmed cell...
This week, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to infigratinib for patients with advanced or metastatic cholangiocarcinoma with a certain genetic mutation, and Orphan Drug designation to the treatment for patients with cholangiocarcinoma. The FDA also granted...
Today, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the treatment of patients with bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have...
The phase III JAVELIN Bladder 100 trial met its primary endpoint of overall survival at the planned interim analysis. In this study, patients with previously untreated locally advanced or metastatic urothelial carcinoma whose disease did not progress on induction chemotherapy and who were randomly...
As reported in The Lancet Oncology by Daniel P. Petrylak, MD, and colleagues, the phase III RANGE trial has shown no significant improvement in overall survival with the addition of ramucirumab to docetaxel in patients with locally advanced or metastatic urothelial carcinoma previously treated...
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Reviews for treatments in extensive-stage small cell lung cancer (SCLC), non–muscle invasive bladder cancer, and BRAF V600E–mutant colorectal cancer. The Agency also recently issued multiple Breakthrough Therapy designations and ...
On December 18, the U.S. Food and Drug Administration (FDA) granted accelerated approval to enfortumab vedotin-ejfv (Padcev) for adult patients with locally advanced or metastatic urothelial cancer who have previously received neoadjuvant or adjuvant treatment with a programmed cell death protein 1 ...
As reported in The Lancet Oncology by Daniel P. Petrylak, MD, and colleagues, the phase III RANGE trial has shown no significant improvement in overall survival with the addition of ramucirumab to docetaxel in patients with locally advanced or metastatic urothelial carcinoma previously treated with ...
The ESMO Congress continues to grow as a pivotal platform for research in clinical oncology. At the ESMO Congress 2019, important findings were showcased in more than 2,200 studies, including 93 late-breaking abstracts. The ASCO Post summarized much of that news in separate articles over several...