Bladder Cancer

The FDA approved an additional recommended dosage of 400 mg every 6 weeks for the anti-PD-1 therapy pembrolizumab (Keytruda), across all adult indications, including monotherapy and combination therapy, Merck reported.

Nadofaragene firadenovec, a novel intravesical gene-mediated therapy, achieved complete response in 53.4% of patients with bacillus Calmette Guérin-unresponsive carcinoma in situ, according to findings from a phase III trial. First author Stephen A. Boorjian, MD, professor of urology at Mayo Clinic, Rochester, MN, discusses the study results and their implications.

Systemic and intravesical therapies are changing the landscape of BCG-unresponsive disease, according to Matthew Galsky, MD.

New results from a study investigating infigratinib in patients having metastatic urothelial carcinoma with activating FGFR3 mutations and/or fusions indicate that the investigational selective fibroblast growth factor receptor 1 to 3 (FGFR1-3) tyrosine kinase inhibitor may have greater activity for treating upper tract urothelial carcinoma than for urothelial carcinoma of the bladder.

Durvalumab (IMFINZI) appears to be feasible as neoadjuvant therapy with preliminary evidence of antitumor activity in patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy.

ImmunityBio announced that the FDA has granted Breakthrough Therapy designation for its interleukin-15 agonist complex, N-803, in combination with Bacillus Calmette-Guerin (BCG), for the treatment of patients with BCG-unresponsive nonmuscle-invasive bladder carcinoma in situ.

The FDA has granted Breakthrough Therapy designation for enfortumab vedotin-ejfv (PADCEV) in combination with the anti-PD-1 therapy pembrolizumab (KEYTRUDA) for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting.

High-grade nonmuscle-invasive bladder cancer is characterized by high rates of disease progression following introduction of bladder-preservation therapy after treatment with Bacillus Calmette-Guérin.

“Histologic subtype shouldn’t exclude patients from getting checkpoint inhibitor therapy,” says Natalie J. Miller, MD, PhD.

"In this era of BCG shortage, we may be forced to develop new standards and alternative strategies for bladder preservation," writes Badar M. Mian, MD.

"It certainly looks like these new therapies will provide better results. From the research and literature, it looks like significant improvement," says one urologist.

“Our study showed that at least with the regimen used in our trial, patients can have chemotherapy in addition to radiotherapy without any fear that it will impair their quality of life,” says researcher Robert A. Huddart, MD, PhD.

“In the OLYMPUS trial, more than half of patients receiving the gel had complete regression of their cancers, and most of the responses were durable. Based on these results, if UGN-101 is approved, it can be strongly considered as a kidney-sparing option for a challenging cancer," says John L. Gore, MD, MS.

“The results of our retrospective study support taking advantage of the Cxbladder test to identify patients who should be further evaluated for cancer and to spare those who likely do not have cancer from an unnecessary workup," says Badrinath Konety, MD, MBA.

“We’re in an era of more personalized or precision medicine, and the ability to target cancer treatment to a patient’s specific genetic mutation or biomarker is becoming the standard,” according to Richard Pazdur, MD.

The FDA has approved the anti-PD-1 therapy pembrolizumab (KEYTRUDA) as monotherapy for the treatment of patients with Bacillus Calmette-Guerin-unresponsive, high-risk, nonmuscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

The FDA has granted accelerated approval to enfortumab vedotin-ejfv (PADCEV) for the treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before or after surgery or in a locally advanced or metastatic setting.

The BCG shortage, overuse of cystoscopy, and hematuria evaluation approaches are among the topics of the most-read Urology Times articles from 2019 on bladder cancer.

A study investigating discharge destination and perioperative complications after radical cystectomy provides useful data for risk stratification and preoperative counseling of patients 80 years of age and older, said Hayden M. Hill, MD, who presented the research at the American College of Surgeons Clinical Congress in San Francisco.

Financial toxicity is prevalent among patients with bladder cancer, according to findings from a cross-sectional study presented at the American College of Surgeons Clinical Congress in San Francisco.

"It’s critically important to not overemphasize the benefits or overlook the concerns related to new technology or surgical approaches as is too often the case in the marketing campaigns by various centers (both academic and community)," writes Badar M. Mian, MD.

Adding immunotherapy in the form of atezolizumab (Tecentriq) to platinum-based chemotherapy extends progression-free survival compared with chemotherapy alone in patients with previously untreated metastatic urothelial carcinoma, according to results from a phase III study.

Access to novel therapies early in the regulatory process as a result of the FDA’s accelerated approval program can be valuable for many cancer patients, but the clinicians who are responsible for their care must have heightened vigilance for incoming data and FDA guidance about these drugs that have not gone through the “gold standard” of phase III testing.

Combined treatment with nivolumab (Opdivo), 1 mg/kg and ipilimumab (Yervoy), 3 mg/kg resulted in a 38% overall response rate in a study of platinum-pretreated metastatic urothelial cancer patients.

Despite recommendations for low-intensity cystoscopic surveillance in low-risk non-muscle invasive bladder cancer patients, U.S. Department of Veterans Affairs providers overused cystoscopy in 75% of these patients, according to a study published in Urology (2019; 131:112-9).